Contact Congress to stop FDA & Big Pharma’s attempt to control supplements and get power to ban kratom

Contact Congress to stop FDA & Big Pharma’s attempt to control supplements and get power to ban kratom

The Prescription Drug User Fee Act reauthorization is being used to give the FDA even more power to threaten kratom and all supplements

First off, we understand this is getting into the legislative weeds, but this is incredibly important as it could change how all supplements and kratom are controlled by the FDA. 

The Prescription Drug User Fee Act or PDUFA is up for reauthorization, and proposed changes to it could give the FDA power to deny registration of all supplements; granting them power to require kratom to be registered, and therefore the power to deny registration and effectively ban all kratom products

Please contact your congressional representatives today! Go to Protectkratom.org/congress using the link below to complete the email contact for to tell Congressional officials not to support any attempts to require supplement registration.

Supplements are not prescription drugs, and shouldn’t be treated the same.  

NOTE: The House Committee on Energy & Commerce is meeting on the PDUFA regulation for the House so we’ve created an additional contact form to be used for them as well. 

After years, pharmacy-middleman suit might finally come to trial

 

After years, pharmacy-middleman suit might finally come to trial

https://ohiocapitaljournal.com/2022/05/16/after-years-pharmacy-middleman-suit-might-finally-come-to-trial/

Since at least 2016, Ohio pharmacists have been accusing large companies acting as pharmacy middlemen of abusive practices, which they deny. And since 2019, the state has been accusing them as well, in the form of lawsuits.

Now, after years of wrangling in court, some of that litigation might be headed to trial.

The middlemen, known as pharmacy benefit managers, operate behind the scenes, but they’re part of some of the largest corporations in the United States. And the big three, which handle prescription transactions for more than 70% of covered Americans, are part of companies that also own major insurers.

Pharmacy benefit managers, or PBMs, negotiate rebates from drugmakers, in part by controlling which drugs are covered by insurance and at what level. They contract with networks of pharmacies and decide how much to pay them for the prescriptions they dispense.

In 2016, two of the big-three PBMs — CVS Caremark and OptumRx — were working for Ohio’s five Medicaid managed-care companies. Late that year, many Ohio pharmacists complained, the companies slashed their reimbursements and then CVS — which was also their biggest retail competitor — offered to buy them out.

CVS and OptumRx insist their reimbursements have been fair and that their actions have saved money for consumers and taxpayers. But amid a newspaper investigation and one by then-Auditor Dave Yost, the Ohio Department of Medicaid in 2018 commissioned an investigation that showed that in 2017, CVS and OptumRx charged taxpayers $244 million more for Medicaid drugs than they paid the pharmacies that dispensed them.

While that was a bombshell, big portions of the analysis were redacted. Under prodding from lawmakers and the press, then-Medicaid Director Barbara Sears moved to release an unredacted version. CVS and Optum sued on July 16, 2018 to block release.

That suit continues, even though The Columbus Dispatch was able to get behind the redactions and show that CVS in 2017 reimbursed big competitors such as Kroger and Walmart much worse than it did its own pharmacies.

The case has languished for almost four years, with Franklin County Common Pleas Judge Andy D. Miller most recently granting another delay last month.

But another, perhaps more substantive case, appears to be moving ahead.

After he became attorney general, Yost in 2019 sued OptumRx over its dealings with the Ohio Bureau of Workers’ Compensation. That suit claims that Optum defrauded the agency of $16 million by not providing guaranteed discounts and through other practices.

It’s slated for trial before Franklin County Common Pleas Judge Michael Holbrook on Oct. 24, and the parties seem to be getting ready for trial.

“We are in the discovery process and planning accordingly for our trial date in October,” Yost’s spokesman, Steven Irwin, said in an email on Tuesday.

A spokesman for OptumRx again denied that the company had done anything wrong.

“We are honored to have delivered access to more affordable prescription medications for the Ohio Bureau of Workers’ Compensation and Ohio taxpayers,” the spokesman, Andrew Krejci, said in an email. “We continue to believe these allegations are without merit and will vigorously defend ourselves.”

Yost also has sued another of the big-three PBMs, Express Scripts, on behalf of the Ohio Highway Patrol System. The suit seeks an unspecified dollar amount after Express Scripts “egregiously charged for services it didn’t deliver,” Yost said. 

Express Scripts also denied wrongdoing. The case now is slated for trial before Franklin County Common Pleas Judge Colleen O’Donnell in June 2023.

When he announced the workers’ comp suit, Yost said it was the start of a flurry of litigation against the pharmacy middlemen, and his office is said to be pursuing other claims.

He tallied a big win last year after he sued Medicaid managed-care provider Centene over dealings using its in-house PBMs. Centene didn’t admit wrongdoing, but it agreed to pay Ohio $88.3 million and set aside an additional $1 billion to settle similar claims in states that hadn’t even sued.

 

Medicare Advantage Versus Traditional Medicare

Medicare Advantage Versus Traditional Medicare

https://www.daily-remedy.com/medicare-advantage-versus-traditional-medicare/

Financial engineering is a derisive term given to private equity firms who spruce up the value of their portfolio companies by manipulating cash flow statements on Excel spreadsheets.

Technically, the company is performing at the same level as before, but on paper it looks much better.

In healthcare, we find a similar phenomenon, called clinical engineering. By manipulating the documentation and reimbursement coding, healthcare systems can appear to provide greater value to their patients than what they really offered.

We find this among health systems that offer Medicare Advantage plans, the latest rendition of health management organizations (HMOs) and preferred provider organizations (PPOs). They use different payment mechanisms to receive financial remuneration for clinical services rendered, instead of the traditional fee-for-service model, where a set amount is given for a specific clinical service. These health systems incorporate a far more complicated financial scheme.

Centers for Medicare and Medicaid Services (CMS) rates Medicare Advantage plans based on over 40 quality measures. These measures are then benchmarked against other similar health plans across the nation. Reimbursement becomes a complex mix of base compensation and premium reimbursements, which often have less to do with clinical care and more with financial incentives.

Most patients are not aware of the payment differences. To them, it is all the same, because the premiums paid by members of Medicare Advantage and traditional Medicare plans remain roughly the same. But the reality is these two payment models could not be further apart – and with different financial structures come different financial incentives.

The Office of Inspector General (OIG) acknowledges as much, and in a scathing report last Fall took many Medicare Advantage plans to task, particularly the United Healthcare plans, citing overly aggressive documentation practices as the primary driver of clinical value, more than any true clinical improvements in patient care.

The Commonwealth Fund confronts this uncomfortable notion at face value and evaluates the clinical value gleaned from Medicare Advantage plans compared with traditional plans.

It discloses every moral hazard and exploitable opportunity available in Medicare Advantage plans as they are currently structured. It details the very mechanisms of clinical engineering so many Medicare Advantage plans have enjoyed for nearly half a decade.

It concludes by demonstrating little to no true clinical value gained in Medicare Advantage plans relative to traditional Medicare plans. The implications prompt an awkward question we should all be asking: Should we have less regulation and oversight in healthcare?

Medicare Advantage plans were touted as the latest and greatest attempt to improve the almighty behemoth that is healthcare. Yet it is susceptible to the same failures as all other prior so-called-saviors in healthcare. The recurring failed attempts show an undeniable fact: When clinical value depends on the quality of documentation, it ceases to be an appropriate metric for quality of care.

This presents an interesting paradigm, known as Goodhart’s Law: “When a measure becomes a target, it ceases to be a good measure”. When clinical documentation becomes the primary driver to measure quality in healthcare, the documentation becomes a poor marker of quality.

This is a uniquely challenging quagmire for regulators. The federal government has created a system of oversight ostensibly reliant on documentation. But if the very metric to regulate healthcare becomes a poor marker of quality of care, then regulators must question their very basis of oversight.

We assume clinical data is good and we reward Medicare Advantage plans for maintaining good clinical records. But the value of data quickly deteriorates when it becomes nothing more than the tool which health plans use to manipulate clinical outcomes.

In the ever litigious culture of healthcare, we gravitate toward the quantitative. We value what we can measure. And we regulate whatever can be measured. But eventually, what we measure ceases to be a good metric of what we are targeting. And for Medicare Advantage plans, it seems we are at this point, particularly where every measurable metric provides some form of reimbursement.

Perhaps we should focus less on measuring the seemingly endless array of metrics, and relieve health systems of the burden of measuring metrics as a whole.

We may find something more valuable than a metric to measure: We may find the implicit motivation to improve patient care.

 

Walgreens reaches opioid settlement with State of Florida

It appears that in FLORIDA Walgreens is being sued for “contributing” our fabricated opiate crisis and in CALF they are being sued for having their stores understaffed and putting pt’s safety at risk from mistakes Walgreens’ Priority Was Filling Drug Orders Fast, Judge Told

https://www.tobaccofreekids.org/assets/factsheets/0365.pdf     Florida got 10+billion out of the Tobacco settlement at the end of the last century. I don’t know if they were hoping to extend the “annual annuity payments” from the tobacco settlement with suing the pharma industry.  It appears that this settlement comes up short.

Florida may be returning to the pharmacy environment back in the mid 2010-2020 decade… when most chain pharmacists were SELDOM COMFORTABLE filling Rxs for controlled meds… the term was coined back then as the “Pharmacy Crawl”..where pts trying to get a controlled Rx filled may have to go to a dozen or so different pharmacies in trying to get a controlled Rx filled.  Can you imagine a chronic pain pts … having to drive around most of a day to find a pharmacy to fill their pain med Rx ?  Back then controlled Rxs were still “paper”, so the pt had a Rx in their hand. Today, most all controls are now sent to a pharmacy electronically. When a pharmacy/pharmacist can’t/won’t fill a C-II,  the Rx basically goes dead, because the pharmacy can’t do nothing but CANCEL the electronic Rx… and the pt is having to have to reach out to their prescriber to send it to another pharmacy. Of course, pharmacies will not tell a pt over the phone if they actually have a particular C-II in stock. When one of the early statements in the early part of the war on drugs was “JUST SAY NO”… may take on a new meaning for chronic pain pts trying to get their pain meds filled .

Walgreens reaches opioid settlement with State of Florida

DEERFIELD, Ill. — Walgreens announced Thursday that it has entered into an agreement with the State of Florida to resolve all claims related to the distribution and dispensing of prescription opioid medications across the company’s pharmacies in the state.

The settlement amount of $683 million includes $620 million to be paid out to the State of Florida over 18 years, as well as a one-time payment of $63 million for attorneys’ fees.

The settlement includes no admission of wrongdoing or liability by Walgreens.

“As the largest pharmacy chain in the state, we remain focused on and committed to being part of the solution, and believe this resolution is in the best interest of all parties involved and the communities we serve across Florida,” said Danielle Gray, executive vice president and global chief legal officer, Walgreens Boots Alliance. “Our pharmacists are dedicated health care professionals who live and work in the communities they serve, and play a critical role in providing education and resources to help combat opioid misuse and abuse.”

As one of Florida’s leading health care providers, Walgreens has taken a number of actions to prevent and respond to the opioid crisis, while continuing to serve patients, including:

  • Providing patient education on safe opioid use
  • Making life-saving Naloxone, the opioid overdose reversal medication, available in all Walgreens pharmacies nationwide
  • Providing safe and convenient medication disposal kiosks available at 1,400 Walgreens stores, along with other safe disposal options at all other Walgreens locations
  • Deploying technology to help pharmacists ensure they are dispensing prescriptions written for a legitimate medical purpose
  • Stopping self-distribution of opioids and all pharmaceuticals to Walgreens stores in 2014

The settlement funds will be used by the State of Florida to support its efforts to combat and treat opioid addiction. The settlement is a result of unique facts and circumstances concerning the state of Florida. It should not be used to forecast or predict the value of any other litigation claims or future settlements, and is unrelated to any other opioid-related litigation in which Walgreens is involved and which the company will continue to defend vigorously.

Click to access 0365.pdf

Walgreens’ Priority Was Filling Drug Orders Fast, Judge Told

Walgreens’ Priority Was Filling Drug Orders Fast, Judge Told

A former Walgreens pharmacist felt pressured to “fill, fill, fill” prescriptions while working at a pace that made her fear making fatal errors, a California federal judge heard in recorded testimony Thursday in a multibillion-dollar bellwether trial over claims Walgreens and others illegally fueled San Francisco’s opioid epidemic.

The city of San Francisco has accused Walgreens, along with drugmakers Teva and Allergan and drug distributor Anda, of creating a public nuisance by marketing opioids with misleading messages about their safety and failing to prevent the ensuing flood of painkillers from being diverted for improper uses.

Thursday marked the second day of the bench trial in which the testimony focused on San Francisco’s case against the pharmacy chain. It included the recorded deposition of Rebecca Gayle, who worked at a San Francisco Walgreens as a staff pharmacist from 2012 to 2016, also holding the role of assistant store manager from 2014 to 2016.

“The most challenging part of working at Walgreens was I constantly felt there was the pressure to fill, fill, fill, and that was what the company cared about most,” Gayle said. “That’s the message I got.”

The demand to fill prescriptions quickly made it difficult for her to investigate suspicious prescriptions or talk to patients about their medications.

“I constantly got feedback to go faster, shave down on the things that were most important to me as a pharmacist like counseling patients,” Gayle said, later adding, “I ran into situations where I was afraid I made a lot of mistakes that could result in severe patient … harm or even death, depending on medication and the type of error.”

During Gayle’s cross-examination, a lawyer for Walgreens asked her if she believed she and her colleagues were doing their best on behalf of their patients and to make sure they prevented diversion.

“I feel like we, as pharmacists, could have had many more tools, and support from a staffing and time perspective, to do more due diligence to prevent diversion,” Gayle said. “We were doing our best, but it was limited given the volume of prescriptions we were filling and the pace at which we were expected to fill.”

Gayle said she would sometimes search doctors’ names on the internet if she felt something was fishy about them, as well as leave notes for her colleagues to warn them about doctors who appeared to be issuing excessive opioid orders.

If there was a strong red flag, Gayle said she and her colleagues would sometimes refuse to fill a prescription.

Brian Swanson of Bartlit Beck Herman Palenchar & Scott LLP, an attorney for Walgreen’s, asked Gayle if she was ever punished for refusing an order, and she said no.

Among doctors who had “fishy” prescribing practices was Collin Leong, Gayle said. He ultimately lost his license in 2013 and pled guilty to selling opioid prescriptions to homeless people with no medical justification, but not before Walgreens filled thousands of his prescriptions, according to a document the city filed with the court. 

An attorney for San Francisco showed Gayle a news article that said the homeless people would be given cash for the pills from a third party. Leong charged $80 to $150 for a prescription, taking in about $400,000, according to the news report.

“Did your district managers ever ask you to identify suspicious prescribers so they could warn others?” the attorney asked. Gayle said no.

Another former San Francisco Walgreens employee, Victor Lo, also testified that the store he worked at was inadequately staffed, making it difficult to do his job carefully.

“We always felt like we were behind, we always felt, at least I felt, I could potentially dispense something incorrectly,” Lo said.

Lo, however, testified that when he told his supervisor that he felt the pharmacy was dispensing a lot of narcotics from doctors who appeared to be “too free” in writing prescriptions, he was told the pharmacists couldn’t say no.

“We couldn’t categorically say flat out we’re not filling these prescriptions from a licensed prescriber. Those prescribers could sue Walgreens,” Lo said he was told.

In addition to Lo, live testimony was given Thursday from Carmen Catizone, who said Walgreens did not meet the standard of care legally required of pharmacies. Among concerns, from 2003 to 2012, Walgreens had a policy passed on to pharmacists to merely call the doctor who issued a questionable prescription as opposed to doing any other due diligence.

“This is especially true when the prescriber may be assisting the patient to inappropriately use controlled substances,” Catizone said.

In 2013, Walgreens introduced a checklist for pharmacists to use when dispensing some drugs, but it didn’t cover some commonly diverted opioids. Until 2020 the checklists were maintained only in hard copy at each pharmacy, and not electronically, so they could be shared with other stores, Catizone said.

During cross-examination, Swanson took aim at the list of “red flags” or warning signs that suggest opioid abuse or diversion that Catizone said pharmacists are required to be on the lookout for.

“You don’t cite any federal or state statute that discloses each of these specific red flags you identify, do you?” Swanson asked, later noting that they also don’t appear in the Controlled Substances Act.

Swanson also posed several hypothetical situations to Catizone that would result in a legitimate prescription being flagged. For example, if a patient obtained multiple opioid prescriptions from different prescribers.

“That would flag a patient who broke a leg and then gets an opioid script from the ER and then gets a second prescription from the orthopedist who treats them,” Swanson noted.

Walgreens’ lawyer also said pill volume wasn’t necessarily a red flag, for example, if a doctor was prescribing for an oncology patient or for pain management.

Catizone’s time on the stand was about 30 minutes, in keeping with Judge Breyer’s orders and a tight trial timetable, limiting direct witness examinations to written declarations with only a short live introductory summary.

Catizone, who served as the executive director and CEO of the National Association of Boards of Pharmacy from 1988 to 2020, also submitted a 35-page declaration to the court.

The Bay Area litigation is the first to rope together defendants across the pharmaceutical supply chain, from manufacturing to distribution and pharmacy dispensing.

San Francisco is represented by its city attorney’s office, Lieff Cabraser Heimann & Bernstein LLPRobbins Geller Rudman & Dowd LLPAndrus Anderson LLPWeitz & Luxenberg PCSimmons Hanly Conroy LLC and Levin Papantonio Rafferty.

Allergan and its affiliates are represented by Kirkland & Ellis LLP.

Teva and its affiliates are represented by Morgan Lewis & Bockius LLP.

Anda is represented by Foley & Lardner LLP.

Walgreens is represented by Bartlit Beck LLP and Gibson Dunn & Crutcher LLP.

The case is City and County of San Francisco et al. v. Purdue Pharma LP et al., case number 3:18-cv-07591, in the U.S. District Court for the Northern District of California. The MDL is In re: National Prescription Opiate Litigation, case number 1:17-md-02804, in the U.S. District Court for the Northern District of Ohio.

Record Numbers of Americans Are Dying of Overdoses. Instead of Justice, We Get Theater | Opinion

 

https://www.newsweek.com/record-numbers-americans-are-dying-overdoses-instead-justice-we-get-theater-opinion-1706231

The Guggenheim Museum in New York City announced this week that it would be removing the Sackler’s nameplate off of their arts center in response to pressure from activists. “The Guggenheim and the Mortimer D. Sackler family have agreed to rename the arts education center,” a museum spokesperson said in a statement on Tuesday. The Guggenheim was not alone; the Metropolitan Museum of Art in New York also removed the Sackler name from a gallery, as did the National Gallery in London this week.

The Guggenheim’s effort is timely, coming on the heels of another devastating statistic: Nearly 108,000 people died from drug overdoses in 2021. And yet, the sad truth is, embarrassing members of the Sackler family will not bring justice to the victims of the opioid crisis and their families, who are once again being offered busy work as though it were meaningful reform. Scrubbing the Sacklers’ name from museums, like suing them in court, amounts to little more than kabuki theater—and everyone but the victims knows it.

Real justice could not be more urgent. America remains mired in a protracted drug-overdose crisis, with over half a million people dead in just a decade. The crisis is being fed by the ubiquity of dangerous fentanyl in the black market. Despite illegal drugs being the culprit in almost every case, the focus of the media and politicians has been on punishing pharmaceutical companies, in particular, members of the Sackler family who own Purdue Pharma, for which a major case of civil litigation is ongoing.

But the calls for justice for the victims of opioid addiction rarely rise above the symbolic, things like the Guggenheim or the Metropolitan Museum of Art removing the Sackler name from their nameplates. And this is a far cry from meaningful consequences that would help the victims of the opioid crisis.

But the lawsuit is a far cry from what real justice would look like. “The whole thing is kabuki theater,” says Richard Ausness, a legal scholar and renowned opioid litigation expert from the University of Kentucky Law. He told me that while there is a high emotional charge to these proceedings, the actual bearing on the case is minimal. “It ought to be about money,” Dr. Ausness explained. “About who pays what. And instead, they want to make the Sacklers listen to people complain about them.”

It may surprise you to learn that instead of trying to bring the Sacklers to justice, the Department of Justice has done anything but. On multiple occasions, the family agreed to multi-billion-dollar settlements, like a widely-criticized bankruptcy agreement from September of 2021 which mandated that the Sacklers would forfeit Purdue ownership and shell out $4.3 billion to litigants. But it granted the Sacklers sweeping immunity from opioid lawsuits brought against their company Purdue Pharma and its drug OxyContin. The plan was killed last December by U.S. District Judge Colleen McMahon, after the DOJ publicly announced they didn’t like how the Sacklers would be immune to further shakedowns lawsuits.

Oxycontin
WHITE PLAINS, NEW YORK – AUGUST 9: Friends and family members of people who have died during the opioid epidemic protest against a bankruptcy deal with Purdue Pharmaceuticals that allows the Sackler family to avoid criminal prosecution and to keep billions of dollars in private wealth, on August 9, 2021 outside the Federal courthouse in White Plains, New York. For decades the Sackler family, which owned Purdue, knowingly marketed highly addictive painkillers, including Oxycontin. Andrew Lichtenstein/Corbis via Getty Images

So this March, the Sacklers made a new deal, with compensation coming to $6 billion—and immunity from further litigation. Once again, the DOJ pushed to have it overturned, though U.S. Bankruptcy Judge Robert Drain stood firm and overruled. (DOJ is still pushing for an appeal in the federal appeals court.)

Professor Ausness and others I spoke to believe the case will end up at the Supreme Court, and it’s anyone’s guess what happens then. But as it currently stands, the victims will never see a single cent from civil litigation. Unless specified otherwise by state law, litigation settlement funds are at the discretion of state attorneys general, who have historically allocated the vast majority of opioid litigation money to feed state budgets. What little funds go toward “anti-addiction” projects have been spent on ridiculous efforts that have very little do with addiction, like Michigan’s focus on helping new mothers or West Virginia’s emphasis on public education.

The media and prosecutors should have been honest with victims from the start and admitted that putting the Sacklers in jail was never an option. Remember, in the 1990s and 2000s, the hard push for prescribing opioids was at the behest of the federal government. These companies’ advertising strategies weren’t drastically different from those for any other drug. While Big Pharma’s behavior was unethical, that is not the same as it being illegal.

Meanwhile, Americans are still overdosing on illegal drugs in the hundreds of thousands.

Where are the calls for justice for them?

Nurse Vaught Sentenced for Deadly Medical Error

If healthcare providers start/keep getting thrown in jail for medical errors, pretty soon there will be no one to care for people need medical care. Many lethal medical errors that I have read about, most all the “system” contributed to the problem. Some of that is when licensing boards fail to take actions against a practitioner’s license who is a “frequent offender”, other times..it can be grossly understaffed/overworked staff, other times it can be contributed to by automation systems that are not working as designed … either from poor design or malfunctions that have failed to be corrected/fixed.

Nurse Vaught Sentenced for Deadly Medical Error

https://www.medpagetoday.com/special-reports/exclusives/98706

Former Vanderbilt nurse gets 3 years probation for negligent homicide, adult abuse

RaDonda Vaught, the Tennessee nurse convicted after a medical error led to a patient’s death, was sentenced to 3 years of supervised probation, evading a possible prison sentence of up to 8 years.

Today’s sentencing caps a years-long process, including delays caused by the COVID-19 pandemic, that brought to light Vaught’s medical error, led to her prosection, and sparked a national outcry from the medical community.

Vaught, 38, was convicted on March 25 of negligent homicide and impaired adult abuse over the medication error, which resulted in the death of 75-year-old Charlene Murphey at Vanderbilt University Medical Center (VUMC) in 2017. Vaught received concurrent sentences of 3 years probation for the adult abuse charge and 2 years probation for the reckless homicide charge.

The fatal error happened when Vaught, a nurse at VUMC at the time, was preparing Murphey for a PET scan on the day after Christmas. Murphey had complained of feeling anxious ahead of the scan and was ordered 2 mg of IV versed. Vaught mistakenly administered 10 mg of vecuronium to the patient instead, according to a CMS report on the incident. Murphey was transported to radiology for imaging, coded in the scanner, and died shortly after.

Vaught was fired from VUMC on Jan. 3, 2018. The hospital negotiated an out-of-court settlement with the patient’s family, one that required them not to speak publicly about Murphey’s death or the error, according to a report from the Tennessean. An anonymous tipster eventually reported the error to state officials in October 2018, and Vaught was charged by prosecutors in February 2019.

The case has stirred up a national conversation around the implications of criminal persecution for medical errors, an uncommon punishment for what many medical societies consider to be accidents born out of high pressure and high-risk environments.

Vaught’s case has also become a symbol of the policy problems that several experts say can lead to these kinds of errors.

“This is an excruciating case for nurses, because it is so abundantly clear that the conditions under which this particular nurse was working made it impossible for her to practice in a manner that ensured patient safety,” Patricia Pittman, PhD, of the Milken Institute School of Public Health at George Washington University, told MedPage Today via email. “It is a tragic example of what happens when nurse-to-patient ratios are too low. There is over twenty years of research showing this relationship, but policymakers and some healthcare leaders still don’t get it.”

“The case is also a horrifying example of how moral injury works — a situation in which health workers feel betrayed by those in authority and forced to practice in ways that violate their professional ethics,” added Pittman, who is also director of the Fitzhugh Mullan Institute for Health Workforce Equity. “This leads to shame and a sense of helplessness and is a major driver of nurses’ resignations.”

The nurse community has reacted with strong opposition since the verdict in late March. Both the American Nurses Association and the Tennessee Nurses Association released statements following the verdict questioning the original decision to prosecute medical errors.

“Health care delivery is highly complex,” the statement said. “It is inevitable that mistakes will happen, and systems will fail. It is completely unrealistic to think otherwise. The criminalization of medical errors is unnerving, and this verdict sets into motion a dangerous precedent.”

State passes law to make legal off label Rxing – legal in the state

Missouri bill bars pharmacists from questioning Ivermectin effectiveness

https://www.kansascity.com/news/politics-government/article261400142.html

Missouri lawmakers this week passed legislation that appears to bar pharmacists from questioning doctors who prescribe the controversial off-label drugs ivermectin and hydroxychloroquine for patients. The measure, which passed the House on a resounding 130-4 vote this week, was tucked into a bill related to professional licensing. After passing both chambers, the bill now heads to Gov. Mike Parson’s desk. According to its language, the bill would prevent state medical licensing boards from punishing or taking away the medical licenses of doctors who “lawfully” prescribe the two drugs. And it prevents pharmacists from contacting a doctor or patient “to dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use” unless the doctor or patient asks about the drugs’ effectiveness. Sen. Rick Brattin, a Harrisonville Republican, told The Star Thursday he added the amendment after he spoke with doctors who worried they would lose their medical licenses for prescribing the drugs. Brattin, who said he previously bought ivermectin for COVID-19 but has never taken it, described the drug as “politicized.” “Unfortunately, because of the politicization of those two drugs, [doctors are] being targeted,” he said. “I wanted to protect them from that.” The bill, specifically Brattin’s amendment, swiftly drew criticism on social media from people who pointed to the fact that the Food and Drug Administration has not approved ivermectin for treating COVID-19. The drug is authorized for humans to treat infections caused by parasitic worms, head lice and skin conditions like rosacea. The agency has received multiple reports of people who have been hospitalized after taking ivermectin intended for livestock, according to its website. “The Missouri legislature has chosen to ‘own the libs’ by issuing a gag order against every pharmacist in this state from offering their medical opinion on taking either one of those medications—even if it could kill their patient,” former U.S. House candidate Lindsey Simmons wrote on Twitter. Rep. Patty Lewis, a Kansas City Democrat who served on the committee that handled the bill, told The Star Thursday that Democrats agreed to the language in the bill to satisfy a group of hard-right conservatives in the Senate. She said the parts of the bill relating to the two drugs will not change anything in the medical community. She said medical licensing boards already would not punish a doctor for prescribing a drug lawfully. “This language, with a few buzzwords, is to keep some difficult, obstinate, conservative senators quiet,” she said. “It’s not necessary, it’s not needed. It’s ‘do nothing’ language only to make sure the bill does not fail in the Senate.”

 

Woman files CLASS ACTION LAWSUIT against CVS – for refusal to fill C-II for directions > 90 MME



One of the basics of the practice of medicine is the starting, changing/limiting , stopping a pt’s therapy. So besides these Pharmacists violating the American with Disability Act & Civil Rights Act… which both makes it illegal to discriminate against disabled people. It would seems that these Pharmacists are practicing medicine without a license.

I wonder if an attorney would file a complaint with the state’s board of Pharmacy and the Medical licensing board on behalf of all the pts being involved in this class action lawsuit, could be ignored by those licensing boards.  Some states allow complaints against state licensing boards to be filed directly with the state’s Attorney General.

I have had some pts tell me recently that a CVS pharmacist told them that NO CVS PHARMACY will fill a particular controlled med in the immediate area.  I have also been told that ordering of stock for CVS Rx depts is now managed by the pharmacy computer system.  So it would seem that someone at CVS HQ could put a ZERO inventory to be maintained on certain meds at certain stores. Some state Pharmacy Practice Act, require a pharmacy to maintain inventory of meds routinely prescribed in their area. So if CVS HQ is prohibiting a CVS Rx dept to stock certain meds – even though the Pharmacist is regularly  being presented prescriptions to be filled.  Compounding the problem, C-II electronically sent, if they are not filled by the pharmacy/Pharmacist, basically become DEAD… because all paper C-II Rxs MUST BE SIGNED BY THE PRESCRIBER. I have read where the DEA has changed regulations that allows Pharmacist/Pharmacies to electronically transfer such electronic C-II to another pharmacy – HOWEVER – states would have to change their state control rules to allow this and pharmacy computer software would have to be changed.  I do not know  if any states and computer software companies have implement this.

This refusal to fill a pt’s controlled med Rx, seems that many different rules/regulations are being ignored and/or violated.

Here is a recent published article that shows that the MME SYSTEM has NO SCIENCE nor DOUBLE BLIND CLINICAL STUDIES behind it and/or supporting it.  Also, I have not seen any FDA professional prescribing information that mentions the MME SYSTEM regards to prescribing opiates. https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154  So what science or double blind clinical studies is CVS using in establishing this limiting pt’s opiate Rxs to 90 MME/day.  I was always told/taught that all clinical decisions has to be based on CLINICAL FACTS

Unsafe pharmacy conditions put patient safety at risk, spark resignations among pharmacy techs

Survey: Unsafe pharmacy conditions put patient safety at risk, spark resignations among pharmacy techs

https://drugstorenews.com/survey-unsafe-pharmacy-conditions-put-patient-safety-risk-spark-resignations-among-pharmacy-techs

The survey shows that a significant percentage of pharmacy technicians are leaving their roles due to poor working conditions that are creating concerns for patient safety.
Sandra Levy

Senior Editor
Sandra Levy profile picture

Under staffing, increased expectations and new COVID-19 era responsibilities are creating extreme burnout among pharmacy technicians, who are citing concerns about its impact on patient safety, according to a recent survey conducted by the National Pharmacy Technician Association.

The survey of 1,386 pharmacy technicians found that poor working conditions have driven 36% of respondents to plan to leave their jobs within the next three to 12 months. This is in addition to the record-setting 25.7% growth in job transition for pharmacy technicians observed from 2019 to 2021, according to NPTA.

[Read more: Pharmacist shortages are affecting the pharmacy industry]

When it comes to burnout, 91.4% of participants report experiencing burnout caused by unmanageable workloads due to under staffing and increased responsibilities, unrealistic expectations, low wages and even productivity quotas. On top of these demands, 44% of participants said their employers also do not provide legally required breaks.

Still, 91.6% reported that they have a passion for their work. That passion, coupled with concerns about the impacts of burnout, led 56% of respondents to report that these conditions are negatively affecting patient safety. Burnout in pharmacies can result in serious or even fatal medication errors, NPTA noted.

“As the largest organization of pharmacy technicians, our No. 1 priority has always been ensuring the quality and safety of patient care,” said Mike Johnston, CEO of NPTA. “We all have a responsibility to ensure pharmacies make significant changes to these working conditions, not only for the benefit of their employees, but also to protect their patients.”

To support these advocacy efforts to improve patient safety, NPTA has partnered with the Institute for Safe Medication Practices to invite pharmacy technicians to participate in a new, anonymous survey requesting specific accounts of how these working conditions are negatively impacting patient safety. Results from this survey will be shared with regulators, legislators, employers and industry organizations to provide the data needed to bring about change. Anonymous submissions can be made here.

The survey results come on the heels of news last month about a pharmacist shortage being the latest concern affecting the pharmacy industry. Currently, 80% of pharmacies are having trouble finding pharmacists, and many are offering huge sign-on bonuses of up to $50,000 to entice them.

Bridging the gap

The American Society of Health-System Pharmacists also is keeping tabs on the pharmacy technician employment situation.

A recent ASHP survey found that a majority of hospital and health-system pharmacy administrators reported turnover rates of at least 21-30% in 2021, and nearly 1 in 10 had lost 41% or more of their pharmacy technicians. The survey also showed that a growing number of health systems are responding to technician requests for professional development by implementing internal technician training programs.

In response, ASHP has launched PharmTech Ready, a resource to help bridge the professional development and training gaps that are among the drivers of the current nationwide shortage of pharmacy technicians.

PharmTech Ready provides healthcare organizations with tools to develop internal training programs to strengthen their ability to recruit, retain and advance the pharmacy technician workforce. The program aligns with the didactic learning requirements of the ASHP/Accreditation Council for Pharmacy Education Model Curriculum. Users can adapt the training program to a variety of settings and methods of delivery for technician training programs. The program features over 160 hours of entry- and advanced-level content on more than 70 topics and includes supplemental materials that will allow healthcare organizations to leverage their sites for experiential training.

“The growing shortage of pharmacy technicians poses a significant challenge to achieving optimal medication outcomes and protecting patient safety,” said ASHP CEO Paul Abramowitz.  “PharmTech Ready draws on ASHP’s extensive experience in developing education and practice resources for the pharmacy workforce and will help technicians build the skills needed to fulfill their essential role on the healthcare team.”

PharmTech Ready includes access to a range of exclusive ASHP continuing education, tools and other resources to bolster pharmacy technicians’ professional development and support their career advancement as critical members of the healthcare team.