Chronic pain pts not the only high acuity patients having trouble getting their medications

Posted on December 24, 2024 by Pharmaciststeve

An insurance CEO was gunned down. Malignant health care system in Kansas explains reaction.

https://coloradonewsline.com/2024/12/23/an-insurance-ceo-was-gunned-down-malignant-health-care-system-in-kansas-explains-reaction/

I remember the room so clearly. It was a small conference space in the Concord Monitor newspaper office in New Hampshire, scarcely big enough for two people. I had ducked into the room to make a phone call to a mail-order pharmacy, one of the “conveniences” required by my health insurance company.

My voice shook, and I could barely contain my emotion.

Do you understand that I need this drug to live? I told the person on the other side. Do you understand that without this medicine I will die?

If you want to understand why so many Americans of disparate political ideologies have cheered on Luigi Mangione, the man accused of killing UnitedHealthcare CEO Brian Thompson, you might look to that moment, one that I’m confident has been shared by countless people in recent decades. The exact medicine I was talking about doesn’t matter in the grand scheme of things — some folks depend on EpiPens, others on asthma inhalers, others on insulin, others on antiretroviral therapy, still others on chemotherapy drugs.

Until you find yourself on that call, begging our nation’s health care cartel to keep you alive, you don’t know what it’s like.

The shame grinds at you.

But at least there’s some sort of coverage underneath it all. You’re not one the approximately 172 Kansans who died this year because of the Legislature’s blinkered refusal to expand Medicaid. Imagine their friends and families, reeling from preventable carnage.

We have numbed ourselves, I think, to the shocking cruelty of it all, to the everyday horror of begging for medicine, for medical care, for someone to listen. Insurers and the dubious shell companies they spawn (take a look into pharmacy benefit managers sometime) enjoy record profits. Meanwhile, everyday folks grit their teeth and persist.

Those a rung or two lower on the social ladder? Forget about it.

Mangione has been apprehended and will face justice. Murder and violence, no matter the motivation, are wrong. Killing Thompson not only wounded his loved ones and friends, but it arguably makes efforts to improve the system more difficult. No CEO wants to appear as though fear has changed their behavior.

Yet when so many feel powerless as a system runs roughshod over them, we should not be surprised that some number (perhaps larger than we imagine) will condone horrifying violence.

Consider that the Kansas Legislature passed Medicaid expansion — yes, passed it — a mere seven years ago. Then-Gov. Sam Brownback vetoed the bill, and lawmakers couldn’t override him. Each year, advocates trek to the Statehouse in Topeka and make their case. Each year, think tanks issue papers showing how many more parents and children would be covered. Each year, the news media points out the clear good that such a move could make.

One year, demonstrators even unfurled banners covered with red handprints, declaring the legislators had blood on their hands. Others have tried mildly disruptive tactics, anything to seize the attention and make the case.

We know the cost — you can calculate it with publicly available numbers. Once 2024 ends in a couple of weeks, some 1,720 Kansans will have died over 10 years.

Yet nothing happens.

Writ large, the same story has played out across the nation. Despite the Affordable Care Act’s success in covering more Americans, the law did not prevent for-profit insurance companies from playing the angles to maximize their take. It has not meaningfully lowered prices. Mangione’s manifesto points out — entirely accurately — that we spend more money on health care in the United States than any other nation yet see poor health outcomes.

Mangione faces first-degree murder charges in New York. If found guilty, he will face punishment from society. We punish those who commit acts of violence against others — as long as they do it one-on-one. The German philosopher Friedrich Engels described a different kind of murder in 1845. He called it “social murder,” described it as occurring when society’s elites created conditions for the poor that inevitable prove fatal.

“When society places hundreds of proletarians in such a position that they inevitably meet a too early and an unnatural death, one which is quite as much a death by violence as that by the sword or bullet; when it deprives thousands of the necessaries of life, places them under conditions in which they cannot live – forces them, through the strong arm of the law, to remain in such conditions until that death ensues which is the inevitable consequence – knows that these thousands of victims must perish, and yet permits these conditions to remain, its deed is murder just as surely as the deed of the single individual,” he wrote.

Engels also helped create communism with Karl Marx, so skepticism might be warranted. Yet he precisely defines the socially excused violence that threatens our state and nation.

The political process, if working correctly, should reform the mechanisms that create such suffering. Successive generations of reformers, from Teddy Roosevelt to Franklin Roosevelt to Lyndon Johnson, created a web of safety nets. Untold numbers of lives were saved.

Yet that process has solved fewer and fewer problems of late. Americans feel in their bones that something is amiss, that something has gone wrong and needs fixing. Conservatives blame liberals, while liberals blame conservatives. Neither want to blame actual culprits, the wealthy, because they underwrite each party’s existence.

Extremism flourishes when officials close off everyday avenues of social and government change.

I fear it, from any party or ideology. Once lit, certain fires can be difficult to extinguish. We have witnessed the results of popular uprisings over the past 150 years, and they do not fill one with confidence. Revolution often ends poorly. Dictators and strongmen rise, while the ultra-wealthy flee to stable fortresses elsewhere.

We know what we need to do. Create a responsive government at the state and national levels. Lower health care costs without sacrificing coverage or quality. Reorient society from a win-at-all-costs mindset to the neighborliness of an earlier age. Show others the caring we would hope they show us.

Yet how can we plausibly achieve these goals? Ideological chasms yawn. Many have abandoned hope, drawn into black holes of nihilism. Those of us who dare to imagine better outcomes wonder if we lead others astray by doing so.

We are all locked in that room together now, still on that phone call, begging for our lives.

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Another “I’m not comfortable pharmacist” throwing a intractable chronic pain pt into COLD TURKEY WITHDRAWAL

Posted on December 24, 2024 by Pharmaciststeve

From this interaction between this pt and this pharmacist – which is really the MOST UNCOMFORTABLE? I am going to share – again- the graphic that explains the potential comorbidity complication – or cause additional comorbidity issues – from under/untreated pain. One of the very basic functions of the practice is the starting, changing or stopping a pt’s therapy. Does this pharmacist’s action – and many other Pharmacists that “we” never hear about – are potentially practicing medicine without a license?

Here is something – are these Pharmacists violating the oath that we all took – JUST LOOK AT THE FIRST LINE (PROMISE) of the Pharmacist’s Oath!

Should pts and prescribers start filing complaints with respective state Boards of Pharmacy with this Pharmacist Oath enclosed/attached?  If the pharmacy boards gets enough complaints – will some of them become UNCOMFORTABLE?

Oath of a Pharmacist

The revised Oath was adopted by the AACP Board of Directors and the APhA Board of Trustees in November 2021. AACP member institutions should plan to use the revised Oath of a Pharmacist during the 2021-22 academic year and with spring 2022 graduates.

“I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

  • I will consider the welfare of humanity and relief of suffering my primary concerns.
  • I will promote inclusion, embrace diversity, and advocate for justice to advance health equity.
  • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for all patients.
  • I will respect and protect all personal and health information entrusted to me.
  • I will accept the responsibility to improve my professional knowledge, expertise, and self-awareness.
  • I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.
  • I will embrace and advocate changes that improve patient care.
  • I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

 

 

In case someone takes issue with the fact that the Pharmacist Oath was recently revised. I found a version where the revisions are in COLOR

Oath of a Pharmacist: Final revised draft

Revised: 6/4/2021

I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

I will consider the welfare of humanity and relief of suffering my primary concerns.

I will apply my knowledge and experience to advance health equity to assure optimal outcomes for all patients.

I will respect and protect all personal and health information entrusted to me.

I will accept the responsibility to improve my professional knowledge, expertise, and self-awareness.

I will champion diversity and inclusion, respect the perspectives of others, and mitigate my personal biases.

I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.

I will embrace and advocate changes that improve patient care.

I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Edits to existing statement

New statement

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Just another Pharmacy Desert created 45 +million people live in a pharmacy desert

Posted on December 23, 2024 by Pharmaciststeve

As Drugstores Close, Older People Are Left in ‘Pharmacy Deserts’

https://www.nytimes.com/2024/12/21/health/drugstore-closures-seniors.html

Shuttered drugstores pose a particular threat to older adults, who take more medications than younger people and often rely on pharmacies for advice.

In July, a notice appeared on the front door of The Drug Store, the only pharmacy in rural Kernville, Calif. After 45 years, the proprietor wrote regretfully, it would be closing in four days and transferring customers’ prescriptions to a Rite Aid about 12 miles away.

As the news spread, “there was a real sense of loss, a sense of mourning,” said Roberta Piazza Gordon, who owns Piazza’s Pine Cone Inn in Kernville. The pharmacy had served as a community crossroads where people chatted with neighbors and with the friendly staff.

Its closing also created practical concerns. “We are an aging population,” Ms. Gordon, 69, said of the townspeople.

She relied on The Drug Store for her blood pressure and cholesterol medications and for anti-inflammatories after injuring her shoulder. Her husband, who is 70, also regularly filled prescriptions there.

At The Drug Store, “you got your flu shot, your Covid shot, your pneumonia shot,” she said.

Now those services require a 20- to 30-minute drive to the Rite Aid, which is in Lake Isabella and which Ms. Gordon described as understaffed for its growing number of customers.

“On any given day, there’s a line of 10 to 15 people waiting at the pickup window,” she said. Unlike The Drug Store, the Rite Aid doesn’t deliver.

That leaves Kernville residents in what researchers call a pharmacy desert, defined as living more than 10 miles from the nearest pharmacy in rural areas, two miles away in suburban communities, or a mile away in urban neighborhoods.

Nearly 30 percent of pharmacies in the United States closed between 2010 and 2021, according to a new study in the journal Health Affairs. After initial years of growth, the number of closures outpaced that of openings from 2018 to 2021.

“It’s an unprecedented decline,” said Dima Qato, the director of the medicines and public health program at the University of Southern California and the senior author of the study.

Like many health disparities, reduced access to pharmacies affects some communities more than others. Closings “happen more in low-income Black and Latinx neighborhoods than any other, and in neighborhoods that are more heavily dependent on Medicare and Medicaid,” Dr. Qato said.

In Miami-Dade County, Fla., for example, more than half of pharmacies closed over the decade, and while many others opened, the county experienced a 5 percent net loss. Forty-one states, and about a third of U.S. counties, had fewer pharmacies in 2021 than in 2010.

“It’s going to get worse,” Dr. Qato said.

Several big chains have more recently announced further closures. When Rite Aid declared bankruptcy last year, the company said it would close 154 locations.

In 2010, it owned about 4,800 pharmacies. When it emerged from bankruptcy in September, it had 1,300.

CVS, the nation’s largest pharmacy chain, opened 100 stores between 2022 and 2024; in that period, it closed 900. Walgreens announced in October that it would shutter 1,200 of its roughly 8,500 stores over three years. Independent pharmacies, the Health Affairs study noted, face more than twice the risk of closure compared with chain stores.

Declines in the numbers of pharmacies pose a particular threat to older adults, who take more medications than younger people do. Nearly 90 percent of seniors reported taking a prescription drug last year, and almost 60 percent took four or more, according to an analysis by KFF, a health research organization.

Moreover, “pharmacies don’t just dispense medications,” said Dr. G. Caleb Alexander, an internist and epidemiologist at Johns Hopkins University and a co-author of the Health Affairs study. “They deliver other services.”

Eighty percent of shingles vaccinations were administered at pharmacies last year. So, too, are 60 to 70 percent of flu shots and 40 to 50 percent of pneumococcal vaccinations during cold and flu season, according to the IQVIA Institute for Human Data Science.

Some pharmacies include walk-in clinics that offer other medical services. At Walmart stores in 21 states, for instance, pharmacists can test customers for strep throat, flu and Covid-19, and provide prescriptions for those who test positive.

When pharmacies close, some customers simply stop taking vital medications. In a 2019 study of older adults taking cardiac drugs — such as statins, beta blockers and blood thinners — adherence to prescribed regimens dropped immediately among those whose pharmacies had closed, compared with that of the control group. The decline persisted after a year.

“These are commonly used medicines that treat important cardiac conditions that people take daily for years,” said Dr. Alexander, a co-author of the study, which appeared in JAMA Network Open.

The decline, though small (5 to 6 percent for each drug category), was “clinically significant,” he continued. “With the number of older adults on these medications and the incredible churn of pharmacies, we’re talking about hundreds of thousands of individuals a year at risk” of discontinuing prescribed drugs.

Experts cite a number of reasons for the wave of shutdowns. Dr. Qato pointed to “a lot of mergers and vertical integration in the pharmacy industry,” as well as low reimbursement rates through Medicare Part D, which covers prescription drugs, and state Medicaid programs.

Others note the huge sums that chains like CVS and Walgreens paid to settle lawsuits related to the opioid crisis.

The role of pharmacy benefit managers has come under particular scrutiny, including from an investigation by the Federal Trade Commission. Its interim report in July was pointedly subtitled “The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.”

These intermediary companies, many affiliated with insurers or pharmacy chains, design drug formularies and negotiate prices. They also determine which pharmacies are in network for insurance plans, and which of those are “preferred,” offering patients lower co-pays.

“That’s why they’re so powerful,” said Ge Bai, a health policy and management researcher at Johns Hopkins. “They control the money.”

Nearly all stand-alone Medicare Part D drug plans, and more than half of Part D plans included in Medicare Advantage, designate preferred pharmacies, the trade publication Drug Channels has calculated.

“Patients don’t go to you if you’re not preferred,” Dr. Bai said. That puts independent pharmacies, less likely to be “preferred,” at risk of lower reimbursement and closure.

Congress, Medicare or the F.T.C. could take steps to address this. Dr. Bai compares financially imperiled pharmacies to rural hospitals kept open with federal support.

“You either let them die, or you subsidize them with taxpayer money,” she said. “It will be expensive to do” but might prevent pharmacy deserts.

Dr. Qato argues that Part D plans should not select preferred pharmacies at all.

“Allow patients to choose which pharmacy to go to, with the co-pay the same, regardless,” she said. “So the pharmacy is reimbursed fairly, whether it’s preferred or not.”

The odds that an incoming Republican administration or Congress would take any such action seems remote, however. Dr. Bai predicted less scrutiny from the F.T.C. in coming years as well.

So older consumers may be navigating the fallout on their own, turning to online and mail-order sources as local pharmacies fold.

In Oxford, Mich., “going out of business” signs suddenly appeared in the windows of the Rite Aid pharmacy last summer.

That was where Jon Katz, 75, a retired ad executive, filled three cardiac prescriptions, and where his wife, Cathy Katz, 68, a retired medical assistant, got antibiotics when needed.

When they picked up anti-seizure medications for their disabled adult son, Joey, the pharmacists greeted him by name. The family was vaccinated for Covid there, too.

Now the nearest pharmacy is a Walgreens in Rochester Hills, 10 miles away. “It’s understaffed and overwhelmed due to the influx of new customers,” Mr. Katz said. “The service is lacking and the technical glitches are too many.” And nobody knows Joey’s name.

But it’s their best option for now — as long as one of them can drive. When older people can’t, Ms. Katz said, “you just hope you have a big, healthy family.”

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Everyone needs to listen to this 4 minute video

Posted on December 23, 2024 by Pharmaciststeve

In this day and age, most healthcare professionals are just employees of a large corporation. They have little/no say over staffing levels. Patients that are in charge of caring for can get possible good or bad care .. depending on the staffing levels. Generally, these attorneys/bureaucrats go after “deep pockets”.  The got after the pharmas, the drug wholesalers, the physicians – they all have deep pockets.

I had never really thought about it until now, but when it comes to hospitals and nursing homes. The attorneys/bureaucrats seem to go after the employees of those entities. Could it be that “they” believe that going after the employees of those corporations will be perceived as a “warning” to the corporation to straighten up in staffing levels and/or the quality/training of the staff so that pts are more properly cared for?

I am not an attorney, but I counted 38 different counts stated in the video and I presume that each one of the 18 staff of the nursing home had 38 charges against each of them. for a GRAND TOTAL OF 684 charges collectively.

It was stated within those 18 staff members, there was the administrator and a nurse, so that state of Virginia is going to after least financially bankrupt the administrator and the nurse and the balance of those charged will need the state to provide them with legal counsel (Public Defender). Will this cause the Nursing Home Industry in Virginia to get their act together?

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A video presentation worth your time to watch

Posted on December 23, 2024 by Pharmaciststeve

This video was done on Dec 3, 2024 and as typical of me, I was little late to the party, since I just watched it today. You would not believe all the links to some video that can be a ONE HOUR+ that are shared with me.  Unfortunately, I have to pick and chose which ones that I have to carve out the time to watch.

One of the most poignant info was from Attorney Kate Nicholson, who stated that just trying to make change only at the state or federal level, success will be fairly limited. Her statement is toward the end of the video.

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When a Pharmacist intentionally throws a intractable chronic pain pt into cold turkey withdrawal

Posted on December 20, 2024 by Pharmaciststeve

I talked to a practitioner a few days ago, this practitioner had a high intensity, intractable chronic pain pt who had been filling a opiate Rx at a local grocery store pharmacy for some time.  All of a sudden, the pt was informed by a Pharmacist at the pharmacy that he “was not comfortable” to continuing filling the pt’s C-2 and this was just a few days before the pt was get a new C-2 filled. In fact, the practitioner had already electronically sent the C-2 Rx to the pharmacy.

The pt had been taking 135 MME/day for some time. I have often stated that one of the basics of the practice of medicine, the starting, changing, stopping a pt’s therapy. In reality, “I’m not comfortable” is not a valid clinical reason for stopping a pt’s therapy and it would suggest that this Pharmacist is totally indifferent to intentionally throwing this pt into a cold turkey withdrawal and within days of Christmas.

I don’t know if this pt was intending to travel to be with family or the pt was planning on having family at their house for Christmas?

IMO, this Pharmacist should be taken before the state pharmacy board for unprofessional conduct and lack of empathy for the cold turkey withdrawal and torturous level of pain the Pharmacist’s action was intentionally causing for this patient.

I wonder what a State Board Pharmacy actions would  take – if any- against a Pharmacist, if a pt would file a formal complaint?

I went out to www.perplexity.ai and asked the following question:

what could be the consequences to a pharmacist that intentionally cut a legit chronic pain patient off their pain meds and intentionally throws the patient into cold turkey withdrawal. Could the pharmacist be charged with practicing medicine without a license

If a pharmacist intentionally cuts a legitimate chronic pain patient off their pain medications, leading to cold turkey withdrawal, the consequences can be severe and multifaceted. Here are some potential outcomes:

## Professional and Legal Consequences
– The pharmacist could face disciplinary action from their professional licensing board, including the suspension or revocation of their license. This is because such actions would violate the standards of professional practice and potentially harm the patient[1][6][8].

## Criminal Charges
– While the pharmacist would not be charged with practicing medicine without a license, as pharmacists are licensed to dispense medications, they could face other charges. For example, they might be charged with negligence, reckless endangerment, or other crimes related to the harm caused to the patient[5].

## Civil Liability
– The pharmacist and the pharmacy could be held liable in a civil lawsuit for any harm or suffering caused to the patient. This could include damages for physical and emotional distress, medical expenses, and other related costs[5].

## Health Consequences to the Patient
– Abruptly stopping opioid pain medications can lead to serious withdrawal symptoms, uncontrolled pain, psychological distress, and even thoughts of suicide. Patients may also seek other sources of opioids, including illicit substances, which can further exacerbate the situation[1][4][6].

## Ethical and Regulatory Violations
– Such actions would violate FDA guidelines and other regulatory standards that emphasize the importance of gradual tapering of opioid doses to avoid serious harm to patients. This could result in regulatory penalties and further disciplinary action[1][6].

In summary, while the pharmacist would not be charged with practicing medicine without a license, they could face severe professional, legal, and civil consequences for their actions. The primary issue would be the violation of professional standards and the potential harm caused to the patient.

Citations:
[1] https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[2] https://www.davidrankinlaw.com/former-pharmacist-arrested-for-practicing-health-care-without-a-license/
[3] https://www.govinfo.gov/content/pkg/FR-2018-04-30/html/2018-09020.htm
[4] https://www.nbcnews.com/health/health-news/cdcs-new-opioid-guidelines-little-late-chronic-pain-patients-rcna74248
[5] https://www.criminaldefenselawyer.com/resources/practicing-medicine-without-a-license.htm
[6] https://www.npr.org/sections/health-shots/2019/10/10/768914092/dont-force-patients-off-opioids-abruptly-new-guidelines-say-warning-of-severe-ri
[7] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[8] https://en.wikipedia.org/wiki/Practicing_without_a_license

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Walgreens’ Woes: Retail Pharmacy Giant Reportedly Weighing Private Equity Sale to Sycamore Partners

Posted on December 19, 2024 by Pharmaciststeve

Walgreens’ Woes: Retail Pharmacy Giant Reportedly Weighing Private Equity Sale to Sycamore Partners

https://www.doximity.com/collections/890523eb-6a52-412a-8533-fb6bbf3abd1b

After a tumultuous run which included making major investments into healthcare delivery assets (most notably VillageMD), Sycamore Partners is reportedly taking Walgreens private as scooped by the Wall Street Journal.

In November, Walgreens parted ways with VillageMD CEO Tim Barry.

It has been a tough few years for the beleaguered retail pharmacy player, and Walgreens has been brought to its knees in 2024. The knockout punch was coming. How did we get here?

Walgreens has been hit hard by uncontrollable secular shifts in consumer behavior. Amazon and others are eating Walgreens’ retail lunch.

The retail side of Walgreens’ business is stagnant and oversaturated with stores, as more consumers shift to online shopping. This challenge is two-pronged. The pharmacy business traditionally operated like a “gas station” model—drawing foot traffic that would lead to retail sales. But as patients increasingly choose online prescription refill services for convenience, fewer people are visiting physical pharmacy stores, resulting in decreased retail shopping at these locations.

So when retail sales sagged, Walgreens needed to make a move in a big way. The big plan involved embarking on an ambitious business transformation journey into healthcare delivery .

This journey jump-started in 2021 with VillageMD as Walgreens cobbled together the below healthcare footprint to sell a healthcare transformation story, including diving into value-based care headfirst.

Execution, however, didn’t go as planned. As Hospitalogists reading this breakdown know, healthcare is hard. Primary care is hard. Value-based care is hard. This dynamic isn’t unique to Walgreens and VillageMD, either.

Unfortunately this assemblage of assets no longer seems to be industry leading.

Plain and simple, Walgreens was desperate and overpaid for what it got in a low-interest rate environment. In its 2024 full year earnings release Walgreens incurred an $8.6B net loss on $12.7B in goodwill impairment charges (meaning they overpaid for these companies and the current earnings/economics could not support the acquired valuation, more or less). VillageMD performance weighed down the healthcare story given acute pressures in Medicare Advantage and changes to risk adjustment, along with significant capital and timeline required to build out an appropriate risk-bearing primary care player.

Unfortunately, unlike CVS, Walgreens lacks some of the most important assets to execute on the strategy (at least so far) to make the flywheel…fly – the PBM and the health insurance plan (side note that CVS isn’t doing particularly well either but for its own reasons).

Despite its own struggles, CVS holds a believable narrative to tell investors. From Q3:

But I digress. This is Walgreens’ share performance since acquiring a majority stake in VillageMD for $5.2B in late 2021, then proceeding to attach Summit Health for $9B in late 2022. At its peak, Walgreens held a $100B+ market cap in 2015.

Today it sits at $8B:

In Walgreens, Sycamore is acquiring a struggling giant, but with a vast revenue base and operating footprint – $147.7B in revenue. While not being an accountant, the impairment charges are largely addressed in 2024, so Sycamore probably thinks there’s significant value to unlock over time as a private company – and tax savings to boot. I’m inclined to agree. Walgreens holds some bright spots. Without being under the gun of quarterly investors Walgreens will have more freedom to reduce its debt load and continue billions of dollars in cost-cutting initiatives (1,200+ store closures in the coming years, capex reductions, working capital reductions). Expect to see Walgreens continue this trajectory but also focus on growing service lines like specialty pharmacy – probably its best acquisition to date.

 

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FDA Says Compounded Tirzepatide Must Exit the Market

Posted on December 19, 2024 by Pharmaciststeve

FDA Says Compounded Tirzepatide Must Exit the Market

Compounders only have 2 to 3 months left to copy injectable

https://www.medpagetoday.com/endocrinology/obesity/113478

The shortage of the diabetes and obesity injectable tirzepatide (Mounjaro, Zepbound) has been resolved, the FDA announced

As a result, compounders will have a grace period of 60 to 90 days to wrap up production and distribution of the combination GIP/GLP-1 receptor agonist during which the FDA won’t take legal action against them, “to avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition,” the agency noted in a letter to maker Eli Lilly

Compounders are only allowed to make copies of a drug when it’s on the FDA shortage list, meaning the demand or projected demand of that drug exceeds the U.S. supply.

First added to the shortage list nearly 2 years ago, the agency initially determined that the tirzepatide shortage was resolved on Oct. 2, prompting it to be removed from the drug shortage list.

But just 5 days later, the FDA was sued by compounders, and as part of a court order, the agency had to reevaluate its decision to remove tirzepatide from the shortage list — a decision that has now been confirmed.

As part of its reevaluation, the agency concluded that the supply is “currently meeting or exceeding demand for these drug products, and that Lilly has developed reserves that it now holds in its finished product inventory, plus significant units of semi-finished product, and has scheduled substantial additional production over the coming months, such that supply will meet or exceed projected demand.”

But even after a shortage is considered resolved, patients and prescribers could still face intermittent localized supply disruptions as products move through the supply chain from the manufacturer and distributors to local pharmacies, the agency noted in their letter.

Furthermore, the 60- to 90-day grace period doesn’t preclude the FDA from taking action for other violations, including in cases of substandard quality or safety concerns.

Approved in 2022 for type 2 diabetes and in 2023 for chronic weight management along with diet and exercise, tirzepatide is the only once-weekly dual GIP/GLP-1 receptor agonist on the market and is arguably the most effective weight-loss injectable

As of today, three other GLP-1 receptor agonists remain on the FDA’s shortage list: semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and liraglutide (Victoza, Saxenda). All have been reported as “available” by their respective manufacturers, but the FDA hasn’t formally declared their shortages to be resolved yet.

The agency said it will continue to monitor supply and demand for these products, including tirzepatide.

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Biden’s DOJ taking its last swing for the fences

Posted on December 19, 2024 by Pharmaciststeve

As you read the accusations of the DOJ on CVS, notice the words they use accused of … alleges …  dangerous and excessive quantities of opioids… trinity cocktails… especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant…. “known ‘pill mills.”…  bearing the hallmarks of abuse and diversion… invalid prescriptions with red flags… what it called CVS’ unlawful practices and to prevent future violations…

THIS IS SUCH BS !!!  Their allegations are nothing but the DOJ doing some statistical number crunching and them “counting” the number of  “statistical out-liars”  as determined by the DOJ or DEA.

There is no mention of a time frame, numbers of prescriptions or any other specific numbers

This year the SCOTUS overturned the Chevron Doctrine which means that federal agencies do not have the statutory authority to create new interpretations of the laws they are in charge of enforcing. In regards to the DEA, think about all the RED FLAGS that they have created during the last 5 decades.

From www.perplexity.ai:

How many prescriptions for opioids/opiates were filled over the last decade

To estimate the number of opioid prescriptions filled over the last decade, we can use data from various sources that track opioid prescribing rates and trends.

National Opioid Prescribing Rates

  • From 2013 to 2015, the annual opioid prescribing rates in the United States decreased from 81.2 prescriptions per 100 persons to 70.6 prescriptions per 100 persons
    1

    .

  • By 2019, the national opioid dispensing rate had further declined to 46.8 opioid prescriptions per 100 persons, and by 2023, it had dropped to 37.5 prescriptions per 100 persons
    6

    .

Total Number of Prescriptions

To calculate the total number of opioid prescriptions, we need the total U.S. population and the prescribing rates per 100 persons.

  • The U.S. population in 2013 was approximately 316 million, and by 2023 it was around 334 million.
  • Using the average population over the decade, we can estimate the total number of prescriptions.

Example Calculation for 2019 and 2023

  • In 2019: With a population of about 328 million and a rate of 46.8 prescriptions per 100 persons, the total number of opioid prescriptions would be:
    328,000,000×46.8100≈15,358,400 prescriptions
  • In 2023: With a population of about 334 million and a rate of 37.5 prescriptions per 100 persons, the total number of opioid prescriptions would be:
    334,000,000×37.5100≈12,525,000 prescriptions

Average Annual Prescriptions Over the Decade

Given the declining trend, we can estimate an average annual number of prescriptions. Here is a rough estimate based on available data points:

  • Average annual prescriptions from 2013 to 2015: Approximately 75-80 prescriptions per 100 persons (midpoint of 77.5)
    1

    .

  • Average annual prescriptions from 2019 to 2023: Approximately 42-46 prescriptions per 100 persons (midpoint of 44)
    6

    .

Using these midpoints and the average U.S. population over the decade (around 326 million), we can estimate:

  • For the period 2013-2015:
    326,000,000×77.5100≈25,295,000 prescriptions per year
  • For the period 2019-2023:
    326,000,000×44100≈14,344,000 prescriptions per year

Total Over the Decade

Assuming a gradual decline from the higher rates in the early part of the decade to the lower rates in the latter part, we can estimate an average annual number of prescriptions. Let’s use a rough average of these two periods:

Average annual prescriptions=25,295,000+14,344,0002≈19,819,500 prescriptions per year

Over a decade (2013-2023), the total number of opioid prescriptions would be:

19,819,500×10≈198,195,000 prescriptions

This is a rough estimate and actual numbers may vary based on more precise data and trends. However, it gives a general idea of the scale of opioid prescriptions filled over the last decade.

Citations:
[1] https://www.cdc.gov/mmwr/volumes/66/wr/mm6626a4.htm
[2] https://www.cvshealth.com/news/pharmacy/cvs-health-fighting-national-opioid-abuse-epidemic-with-enterpri.html
[3] https://jamanetwork.com/journals/jamapediatrics/fullarticle/2781107
[4] https://www.cnn.com/2024/12/18/business/doj-cvs-opioid/index.html
[5] https://www.nature.com/articles/s41598-024-52032-4
[6] https://www.cdc.gov/overdose-prevention/data-research/facts-stats/opioid-dispensing-rate-maps.html

CVS knowingly dispensed ‘massive’ amount of invalid opioid prescriptions: DOJ lawsuit

https://www.newsbreak.com/news/3722553226577-cvs-knowingly-dispensed-massive-amount-of-invalid-opioid-prescriptions-doj-lawsuit

The largest pharmacy chain in America is accused of “unlawfully dispensing massive quantities of opioids and other controlled substances to fuel its own profits at the expense of public health and safety,” according to a civil lawsuit filed by the Justice Department, which was unsealed Wednesday.

The DOJ lawsuit alleges that CVS has, for more than a decade, knowingly filled sometimes-dubious prescriptions for controlled substances that lacked a legitimate medical purpose, or were not valid.

Those prescriptions included “dangerous and excessive quantities of opioids” and “trinity cocktails” — a blend of “especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant,” the suit stated.

The suit also accuses the company of filling “at least thousands of controlled substance prescriptions” penned by “known ‘pill mills.'”

In a statement to ABC News, CVS spokesperson Amy Thibault called the suit “misguided” and said company officials “strongly disagree with the allegations and false narrative” described in the DOJ suit and will “defend ourselves vigorously.”

DOJ’s lawsuit says CVS “contributed to the opioid crisis, a national public health emergency with devastating effects in the United States.” The suit went on to say: “These included illegitimate prescriptions for extremely high doses and excessive quantities of potent opioids that fed dependence and addiction, as well as illegitimate prescriptions for dangerous combinations of opioids and other drugs.“

The suit accuses CVS of ignoring sometimes “egregious red flags” about prescriptions “bearing the hallmarks of abuse and diversion.” The lawsuit points to performance metrics and incentive compensation policies that allegedly pressured pharmacists to “fill prescriptions as quickly as possible, without assessing their legitimacy” and corporate policies that allegedly prioritized speed over safety.

The suit claims CVS refused to implement compliance measures recommended by its own experts to reduce the number of invalid prescriptions with red flags “primarily due to fear that they would slow the speed of prescription filling and increase labor costs,” according to the suit.

The government is seeking civil penalties, injunctive relief and damages to address what it called CVS’ unlawful practices and to prevent future violations.

In her statement, Thibault, the CVS spokesperson, said the company has been an industry leader in fighting opioid misuse.

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

She said the DOJ lawsuit “intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few.”

 

 

 

 

 

 

 

 

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PBM industry TOSS some financial crumbs to pharmacy and ONE national pharmacy associations IS HAPPY

Posted on December 18, 2024 by Pharmaciststeve

This statement below was out on the web from a VP from one of the NATIONAL PHARMACY ASSOCIATIONS.  This person seem very PROUD that pharmacy can expect an additional FIVE BILLION in profits.

The USA fills 4.9 BILLION prescriptions in 2024. Presume that the PBMs decide what is going to be paid for 90% of them or 4.41 BILLION.  I remember when the PBM industry first showed up on the scene in 1970. The year I graduated from Pharmacy school and got licensed.

Back then 90% of Rxs were brand name meds and today 90% of Rxs are generics. Back in 1970 the average Rx price was in the $4-$5 range, vs today the average Rx is in the $70 range. As a guesstimate, I would say that if it was not for the PBM industry, we are paying at a minimum $30/Rx more because we have all these middlemen involved in our prescription system.

Over the last 5 decades, as the percentage of Rx that the PBMs were controlling went up .. the faster the average Rx prices went up. Multiplying out the number of Rxs the PBM industry control – 4,41 billion by $30/Rx comes out to 132 BILLION/YR.

So it appears that the PBM industry is returning FIVE BILLION. That is just abt 4% of what they are now over-charging and padding their bottom lines. I have to wonder what sort of “song & dance” bureaucrats, politicians and other decision makers were told and they believed that a large number of middlemen coming into ANY SYSTEM.. each with its own overhead costs and desire to show a net profit, could reduce overall expenditures on medication. Again, back in the day, it was claimed that prescriptions were 6% of total medical expenditures and today it is reported that medications are now 12%-15% of total medical expenditures.

Over 45 Million Americans Lack Convenient Access to a Pharmacy

  • Over 46% of U.S. counties are pharmacy deserts. In these counties, more than half of people have to drive more than 15 minutes to reach nearby pharmacies.

  • Today, over 45 million Americans live in a pharmacy desert. That’s an increase of over 9% since 2021, and the rate has outpaced population growth.

  • From 2021 to 2024, the number of community retail pharmacies decreased by nearly 15%, worsening pharmacy access across the U.S.

    Nearly 30% of US drugstores closed in one decade, study shows

  • The study found that more than 29% of the nearly 89,000 retail U.S. pharmacies that operated between 2010 and 2020 had closed by 2021. That amounts to more than 26,000 stores.

Congress has pulled the end of year spending package including long overdue PBM reforms due to unrelated issues. The PBM reforms save $5 billion and represent a lifeline to rural and underserved communities access to their only healthcare provider. Congress should not leave town until these reforms get passed – which are supported by over 100 U.S. House members and 34 U.S. Senators, FTC lawsuits and investigations, multiple congressional oversight hearings, investigations and reports, support from the President-elect, and hundreds of pharmacists’ and patients’ calls, letters, and meetings with congressional staff

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