Court addressed how and why a pharmacist may legally decline to honor a prescription

what I find interesting in this court issue is…  what they are talking about is “off-label” prescribing… in which day in and day out… off label prescribing is a significant percent of all prescriptions filled. But “they” seemed to dance around and side-step around the very issue of off-label prescribing. Off labeling prescribing typically has NO SCIENTIFIC EVIDENCE for what the med is being prescribed for, but here our legal system … uses no scientific as a reason for siding with the defendants.  In reality, there is a growing mountain of scientific evidence that these mRNA vaccines, may not be a “vaccine” in the truest sense, and may only – at best – provide some passive immunity to a pt.   In fact, 100 of millions of vaccinations where administered under FDA’s EMERGENCY USE AUTHORIZATION and only having a very brief/abbreviated short term clinical trial.

This was just posted today: The CDC director just got COVID. She got the new bivalent booster a month ago      Pres Biden and Dr Fauci also was tested positive once or twice after getting all the recommended vaccinations…  Yet the CDC is getting ready, at a very minimum, to mandate COVID-19 vaccine for all kids in school.  It would seem that POLITICAL SCIENCE is dictating what our healthcare is doing/recommended.  Someone must be making a lot of money or has a vested interest in all of these mandated vaccinations.

Court addressed how and why a pharmacist may legally decline to honor a prescription

https://www.pharmacytoday.org/article/S1042-0991(22)00798-8/fulltext

The important question of whether a pharmacist may legally decline to honor a scientifically unsupportable prescription continues to be addressed by courts. In December 2021 and March 2022, I reviewed 4 legal cases in which hospitalized patients challenged the hospital’s refusal to administer ivermectin for the treatment of COVID-19. All 4 cases resulted in court rulings favoring the hospital.
A recent case from Minnesota considered similar claims in a community pharmacy setting. The legal rationale of these cases extends beyond the COVID-19 pandemic, to include any situation in which a pharmacist declines a prescription based on scientific evidence.

Background

In the late summer of 2021, a Minnesota husband and wife became ill with COVID-19. They both obtained a prescription for ivermectin from a Missouri physician through a telehealth appointment. The wife also later obtained a prescription for hydroxychloroquine from the same physician.
Two local pharmacies refused to honor the prescriptions. The first pharmacist explained that “it is not appropriate to treat COVID-19 patients with ivermectin.” The second pharmacist cited “corporate policy to refuse ivermectin and hydroxychloroquine prescriptions to treat COVID-19.”
The patients alleged that the pharmacists’ refusal to honor their prescriptions endangered their lives and forced them to use veterinary ivermectin, after which they “experienced rapid and significant improvement.”
The patients sued the pharmacies for “replacing [the physician’s] reasoned judgment and [the patients’] own reasoned decision-making” with “baseless political conclusions” (in the case of the first pharmacy) and a “one-size fits all corporate policy based on political fearmongering” (in the case of the second pharmacy).
The pharmacies moved to dismiss the case.

Rationale

The judge first considered the plaintiffs’ claim that they were asserting their “common law right to self-determination.” The judge reasoned that the implications of recognizing “not just the right to do whatever you want with your own body, but the right to force others to help you (so much for their right of self-determination) would be mind-boggling.”
The judge stated that the recognition of such a right would “completely upend” the regulation of health care professionals.
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The judge then reviewed the plaintiffs’ allegation that the pharmacists’ refusal to honor their prescriptions was “extreme and outrageous” conduct, noting that to meet this legal standard, the conduct must be “so atrocious that it passes the bounds of decency and is utterly intolerable to a civilized community.”
The judge acknowledged that “there might be circumstances under which a pharmacist’s refusal to dispense life-saving medicine to a severely ill person because of the pharmacist’s political beliefs (or because of a policy of the pharmacist’s employer) could be extreme and outrageous.” However, the judge concluded that “this case does not remotely approach those circumstances.”
Lastly, the judge reviewed the plaintiffs’ allegation that the pharmacists had interfered with the physician’s performance of her contract to treat the patients.
However, the plaintiffs conceded that the physician had not breached her contract with them. A person cannot have interfered with a contract between other persons if the contract was actually fulfilled. The judge ruled that the pharmacists had taken no affirmative action to interfere with the physician-patient relationship. They had merely declined to participate.
The case was dismissed.

Takeaways

In the hospital-based ivermectin refusal cases, the courts deferred to medical standards of care that had been approved by hospital committees based on carefully reviewed scientific evidence. In the present case, the judge deferred to the evidence-based judgment of an individual pharmacist (at the first pharmacy) and to corporate policy (at the second pharmacy). These are two different examples of how and why a pharmacist may legally decline to honor a scientifically unsupportable prescription.
Political disagreements have found their way into pharmacy practice. It is uncomfortable, yet it was inevitable. Individual pharmacist decisions and corporate policies that are based on scientific evidence can legally justify prescription refusals in the face of patient insistence due to political factors or other nonscientific beliefs.

Pharmacist sued for confiscating patient’s prescription

Pharmacist sued for confiscating patient’s prescription

https://www.pharmacytoday.org/article/S1042-0991(20)30963-4/fulltext#relatedArticles

Judicial opinions can be frustrating when the judge authoring the opinion has not provided sufficient factual information. That is particularly true of this month’s case. The court’s description of the facts may lead one to believe, and actually hope, that an important fact has been left out of the opinion. It is difficult to imagine that a pharmacist would confiscate a patient’s prescription under the circumstances presented in this case.

Background

The patient was a veteran who allegedly was “suffering from chronic pain associated with a defective hip implant.” He also suffered from other medical conditions and was “not a candidate for surgery.” He was prescribed an extended-release (ER) morphine product that he had “successfully taken for years,” and he faced “substantial medical risks associated with dose reduction.
The patient alleged that he presented his ER morphine prescription at the defendant pharmacy; that the pharmacist “called the prescriber and verified the legitimacy of the prescription;” yet the pharmacist “refused to fill the prescription and confiscated his prescription document, preventing him from filling it elsewhere.
The patient allegedly suffered “severe pain and several days of opioid withdrawal symptoms.” He “was able to see his doctor six days later for a new prescription and was able to fill that prescription at a different pharmacy.
The patient sued the pharmacy based on several legal theories, the most significant of which were professional negligence and conversion. The pharmacy moved to dismiss the case, arguing that the pharmacist “did nothing more than act within his professional obligations and judgment.

Rationale

The court evaluated the four elements of a negligence claim (duty owed, breach of duty, causation, and damages) and concluded that the patient had alleged sufficient facts to support such a claim.
The court then turned to the conversion claim. A civil lawsuit for “conversion” is similar to a criminal prosecution for theft. The main difference is that a conversion lawsuit is filed by a person from whom property was taken against the person who allegedly took the property, while a theft case is filed by the government against the alleged perpetrator.
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The court evaluated the three elements of a conversion claim (plaintiff’s right to possession of the property, defendant’s wrongful act or disposition of property rights, and damages). It concluded that the patient had alleged sufficient facts to support this claim also.
The pharmacy’s motion to dismiss was denied. This does not mean that the pharmacy will lose the lawsuit. It simply means the alleged facts, if proven by the patient, can support liability of the pharmacy.

Discussion

Pharmacists are obligated under the law to investigate suspicious circumstances before honoring controlled substance prescriptions. Unfortunately, these investigations sometimes can be misinterpreted by prescribers and patients. And pharmacists are sometimes overly aggressive in the way they do their investigations and in the accompanying statements they make.

As best practice, pharmacists should adhere to the following suggestions based on case law:

  • Talk with the patient (or the patient’s representative).
  • Talk with the prescriber (or the prescriber’s representative).
  • Never make any disparaging remarks about the patient, the prescriber, or the medication.

  • If suspicions are not resolved, then you may decline the prescription with apologies and the explanation that it cannot be honored based on pharmacy policy. Return the prescription to the patient.

  • If the document presented is confirmed to be forged or otherwise illegal, then call the police and let them do their job. If the police instruct that the prescription should be confiscated, then do so briefly until they arrive to take possession of it as evidence.
  • Do not fill an illegal prescription, even if the police instruct that this be done. It is against the law to knowingly fill an illegal prescription.
  • If threatened, then cooperate. Never say or do anything that may result in harm to pharmacy staff.

Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say

Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say

False positives, false negatives remain a concern

https://www.medpagetoday.com/painmanagement/opioids/101359

A photo of a swab laying on a petri dish which is laying on a DNA sequencing gel.

An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD).

In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of currently available alternative forms of detecting OUD risk.

AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

Currently, no FDA-cleared or -approved devices are indicated for identifying genetic risk for OUD. SOLVD, maker of the AvertD device, submitted an initial de novo classification request for AvertD, which the FDA declined in August 2021. In June 2022, the company resubmitted its request after collecting additional information to address the agency’s concerns.

But for many advisory committee members, questions about the device lingered. “My vote was really based on my concerns about the clinical validity of this test,” said Laura Bierut, MD, of Washington University School of Medicine in St. Louis, who voted no. “I am concerned about the validity of these 15 SNPs really being able to differentiate people with opiate use disorder.”

At the meeting, SOLVD presented results of an observational study that demonstrated an 82.76% sensitivity and a 79.23% specificity for detecting OUD among 385 adults exposed to prescription oral opioids for 4 to 30 days. Slightly more than half (57%) of the sample population were men, and 92% were white.

“There was no safety evaluation of this device, which I thought was a really odd omission,” noted panelist Adam Gordon, MD, MPH, of the University of Utah in Salt Lake City, who voted no.

“We have no idea what the prescribing patterns would be after the test was implemented,” Gordon pointed out. “We have no patient-level outcomes. We have no assessment of both providers and patients of how they would approach receiving results of this test. And I think that’s a really important point because I’m really worried about the false positives.”

“I believe 100% of the risk associated with this test is with false positives and false negatives — both people being untreated or poorly treated because somehow it came back as a positive result, or being given inappropriate treatment because it said negative,” observed Timothy Ness, MD, PhD, of the University of Alabama at Birmingham, who also voted no.

For some panelists, the demographic makeup and sample selection of the study helped sway their decision. “I have a lot of concerns about the demographic population that was sampled in the testing, that it’s not reflective of the population that would actually be treated out there,” noted Sherif Zaafran, MD, president of the Texas Medical Board, who voted no.

And at least one committee member who voted yes did so with reservations. “I voted in favor of approval clearance,” said Wilson Compton, MD, MPE, deputy director of the NIH’s National Institute on Drug Abuse. “I would have preferred not to be able to answer yes or no but to give sort of a balance, and I just barely kicked into the yes area.”

“I heard lots of concerns expressed today about potential risks,” Compton acknowledged. “I expressed a number of those myself.”

“But the part of the question that tipped the balance for me was the second half where it asked for risks and benefits in comparison to current available technology,” he noted. “And to my mind, I think genetic tests are likely to add benefit compared to the currently used risk profile test that clinicians have available at this time.”

Dr. Forest Tennant: Intractable Pain Syndrome | Episode 1

https://youtu.be/RFazRe7TMAk

Florida Gov. Ron DeSantis says there will be no children’s COVID vaccine mandate

We intentionally avoided the first mRNA vaccines and got the J&J/Jansen original vaccine and booster.  This most recent booster they are PUSHING is abt 50% of the original COVID-19 vaccine and other parts are suppose to be effective on the COVID-19 variations of BA.4 & BA.5 and the clinical trial consisted on it being test on a a HANDFUL OF MICE…  Somewhere along the line the J&J/Jansen version of the COVID-19 vaccines…. DISAPPEARED… and “they” start pushing a BOOSTER with VIRTUALLY NO CLINICAL TRIALS….   We are SKIPPING THIS ROUND OF (UNTESTED) BOOSTERS FOR COVID-19

Florida Gov. Ron DeSantis says there will be no children’s COVID vaccine mandate

https://www.foxnews.com/politics/florida-gov-ron-desantis-says-there-will-be-no-childrens-covid-vaccine-mandate

Florida Surgeon General Joseph Ladapo has come out against routine COVID-19 vaccines for children

Florida Gov. Ron DeSantis drew a line in the sand Thursday, telling reporters he is against mandatory COVID-19 vaccine shots for children. 

On Wednesday, a panel at the Centers for Disease Control and Prevention (CDC) voted to add the vaccine to the recommended Vaccines for Children (VFC) Program. It would not make the shots mandatory. 

“As long as I’m kicking and screaming, there will be no COVID shot mandates for your kids,” DeSantis said during a speech to announce an executive order to provide property tax relief for residents impacted by Hurricane Ian. “That is your decision to make as a parent.”

Florida Gov. Ron DeSantis on Thursday pushed back against a CDC recommendation that the COVID-19 vaccine be added to the agency’s recommended childhood schedule. (Joe Raedle/Getty Images)

The governor said his office has received questions about the CDC adding the vaccine and schools potentially mandating students be vaccinated against COVID-19.

“I get a kick out of it when people kind of compare it to (measles, mumps and rubella shots) and things that have been around for decades and decades,” he said. “Parents, by and large, most parents in Florida have opted against doing these booster shots, particularly for young kids.”

“These are new shots,” he said, adding that Florida Surgeon General Joseph Ladapo has not recommended the booster shots for children. “Basically, his reason for that is there’s not been a proven benefit for that.”

Ladapo tweeted about the CDC panel a day before the vote, saying nothing would change in Florida, whatever the result. 

“Regardless of what @CDCgov votes tomorrow on whether COVID-19 vax are added to routine child immunizations – nothing changes in FL,” he wrote Tuesday. “Thanks to @GovRonDeSantis, COVID mandates are NOT allowed in FL, NOT pushed into schools, & I continue to recommend against them for healthy kids.”

Meanwhile, medical experts have pushed back on Ladapo’s stance on vaccines, according to Politico.

Missouri Gov. Mike Parson on Thursday also shared his opposition to mandatory vaccine requirements for children.

“As long as I am Governor of Missouri, I will do everything under my authority to never let the federal government mandate COVID vaccines in our schools,” he tweeted.

Finally – An Honest Portrayal Of Opioid Overdose Deaths

Notice in SECOND GRAPH – post 2016 CDC opiate dosing guidelines OD’s from illegal drugs ( Illegal Fentanyl, Cocaine, Heroin, Meth & other stimulants ) where HIGHER in 2021 Illegal fentanyl significantly so  … whereas, Rx opiates remained fairly CONSTANT. Since both pharma opiate products and prescribed opiate Rxs were declining…  does this suggest that fewer pharma opiates were being diverted ?

Finally – An Honest Portrayal Of Opioid Overdose Deaths

https://www.acsh.org/news/2022/10/19/finally-honest-portrayal-opioid-overdose-deaths-16614

If you’ve ever tried to figure out which drugs are causing overdose deaths the CDC site doesn’t offer much help. Why? Because the way that the agency categorizes drug classes is scientifically flawed at best or deliberately misleading at worst. Either way, it’s a mess. But NIST, a subsidiary of the Department of Commerce has taken CDC’s own graph and relabeled it so that the answers are clear and accurate. The difference is striking.

 

 

The role of the CDC in categorizing opioid drugs

Relatively safe prescription analgesics have become next to impossible to get, regardless of medical need, while far more dangerous street drugs are pouring into the US. Yet the CDC, arguably the primary offender in the anti-opioid movement still maintains significant control of the national conversation on opioid addiction and death. Even though we are years into the “Fentanyl Epidemic” the agency, intentionally or otherwise, still obfuscates overdose death data as you’ll see in the graph below. Why? It could just be sloppy science or it could also be intentional, possibly to minimize the public perception of the harms that its CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 caused. But, as you’ll see shortly, another government agency has, intentionally or otherwise, cleared up the confusion by simply relabeling a part of a graph.

I could not adequately cover the 2016 Prescribing Guidelines in 10 articles, so let’s focus on a single, but important error – the language used in establishing the categories. What does it mean? What are these categories of drugs that are allegedly doing so much harm to those who take them?

Language can be a powerful tool, especially when misused. Let’s focus on the definitions of two of the drug categories, something I’ve written about before (See Stop Calling Fentanyl A Synthetic Opioid. It’s Confusing). It’s a form of “narcotic gaslighting,” where the blame for opioid overdoses remains focused on prescription pills, in language which is difficult to understand unless you’re an organic chemist.

The CDC graph – one problem after another

Figure 1. CDC graph of different drugs responsible for overdose deaths. In some language or other. Pay attention to the terms in the two ovals.

This article is focused on two classifications of drugs, “natural and semisynthetic opioids” and “synthetic opioids other than methadone.” Both terms are scientifically inaccurate; neither term provides any useful information defining which drugs are the killers. Let’s take a look.

In the CDC graph (above), the black oval highlights one of the categories, “natural and semisynthetic opioids,” (referring to the light blue line) –  the number of deaths from this bewildering term. What does it even mean? Unless you happen to understand “CDCese” you can’t possibly know; the term tells us nothing about the drug; not its potency, dosage, or addiction potential. Instead, the category encompasses “natural” opioids (as if that matters) that happen to be “semisynthetic,” whatever that means.

  1. “Natural”

The term “natural” is both irrelevant and also confusing when referring to overdose deaths. It is thoroughly meaningless, yet also misleading, taking advantage of the popular misconception that natural drugs and chemicals are in some way superior or safer than synthetic ones. This is absolutely false. The origin of a drug (or chemical) is irrelevant; its properties are determined by the chemical structure of the drug itself, not whether it happens to be derived from plants, animals, or petrochemicals. Examples of “natural” opioids include codeine and morphine. They are found in poppy flowers. So what? Whether made by a flower or in a factory doesn’t matter one bit. So, why use this term? It is confusing and also misleading. (For an esoteric exercise about the meaning of “natural,” see Note 1. If you dare)

  1. “Semisynthetic”

The term “semisynthetic” is even worse; it refers to drugs that are not found in living organisms but are synthesized from other chemicals or drugs that are. Very few non-chemists would understand what this really means. Drugs in this class include oxycodone and heroin (2); neither is found in poppy but both are made from ingredients in poppy. And, just like the term “natural,” “semisynthetic” tells us nothing about the drugs, only that they were manufactured from natural ingredients in poppy. Absolutely useless information.

  1. The worst of the worst: “Synthetic opioids other than methadone”

If the nonsense about natural vs. semisynthetic is bad, the terminology used for characterizing the opioid drugs that didn’t have the good fortune to be created by a plant is even worse. “Synthetic opioids other than methadone?” What does this even mean? It means nothing. Why? There are two drugs shoved into this category: Fentanyl (the strongest common opioid) and tramadol (the weakest). These two drugs don’t even belong in the same room (or the same medicine cabinet) yet they appear in the same category.

Why? Here’s my guess.  Doing this served a purpose – to downplay the significance of fentanyl deaths (note that fentanyl is not even mentioned) thereby keeping the focus on prescription pills for any number of reasons. (3)

Language matters

The CDC chose to represent drugs that caused overdose deaths using these meaningless classes. Why? These terms make it next to impossible for your average citizen to understand which drugs are responsible for what. To the American public, overdoses are caused by nondescript white pills. Both the CDC used these fuzzy definitions (in my opinion) to obscure the fact that by the mid-2010s street drugs (heroin and Illicit fentanyl) were becoming the primary killers, passing the number of deaths from legal prescription opioids, a trend that would only accelerate with time. The “intentional fuzziness” worked so well that it was difficult (even for physicians) to understand that the opioid overdose crisis had fundamentally changed. Prescription pills were no longer the primary danger. Not even close.

Clarity from a strange place

Let’s look at a slightly different way to present the same data – accurately. The graph below was put together by the National Institute of Standards and Technology (NIST), a subsidiary of the US Department of Commence (2) based entirely on CDC data. There are two seemingly trivial changes in how the data are presented. But those two changes make a world of difference (Figure 2). They actually tell us the truth about the opioid crisis.

Figure 2. Overdose deaths by drug – clearly and accurately portrayed. “Semi-synthetic opioids” has been replaced by “prescribed opioids, such as oxicodone [sic].  The category formerly titled “Synthetic opioids other than methadone” is now “fentanyl and related drugs.” Quite a difference. Both of these categories are now clearly defined. Credit: B. Hayes/NIST (March, 2021) based on data from U.S. Centers for Disease Control and Prevention 

Small changes make a big difference

As mentioned above, the category “synthetic opioids other than methadone” has been replaced by  “fentanyl and related drugs. ‘This is not a trivial change. Finally, someone can look at this graph and see quite clearly what is killing Americans – illicit fentanyl and its analogs.

And the term “natural and semisynthetic opioids” is mercifully gone. It meant nothing in the first place, but its replacement does. The meaningless term has been replaced by an accurate one: “Prescribed opioids.” This include drugs like oxycodone, hydrocodone, and hydromorphone. All of a sudden it becomes very easy to look at CDC data and see what is really going on.

What is especially galling is that the CDC could have made this simple change a decade ago, but the result would have been a far greater understanding of what constitutes the “opioid crisis” – probably something that the CDC had little interest in clarifying.

Incompetence? Sleight of hand? Honest mistake?

You tell me.

NOTES:

(1) But just to screw with your head: There isn’t much codeine in the flower, so industrially it is synthesized from morphine or thebaine, two other components of the flower. Does this make it natural? Yes. Or maybe no. You decide.

(2) If you’re wondering why the US Chamber of Commerce is now weighing in on something that is very far from its mission you are not alone. Then again, drug policies should have never been determined by the CDC; it knows nothing about drugs, something that should be quite obvious by now.

(3)  There’s an awful lot of money to be made by “expert” witnesses who demonize legal opioids in shoddy papers and propaganda-like seminars. Then they pedal their “expertise” to work with lawyers, who seek huge settlements from opioid manufacturers and distributors, regardless of whether they did anything wrong or not. (See PROP Keeps Lying About Opioids – This Time They Got Caught.)

Genetic Testing for Opioid Use Disorder Heads to FDA Advisors

Genetic Testing for Opioid Use Disorder Heads to FDA Advisors

https://www.medpagetoday.com/painmanagement/opioids/101314

To date, no FDA-cleared or approved devices are indicated for identifying genetic risk of OUD

On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD).

AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

The device currently is marketed to physicians and their patients and is paid for either by insurance or by the patient directly at $199.

Currently, no FDA-cleared or approved devices are indicated for identifying genetic risk for OUD. A version of AvertD with 11 of the 15 SNPs now included in the device was granted FDA breakthrough device designation in March 2018.

More recently, the device was assessed in a multi-site observational study that evaluated 385 people after their initial exposure to prescription oral opioids.

The FDA declined SOLVD’s initial de novo classification request for AvertD in August 2021. That decision was upheld on appeal in January. In June, SOLVD resubmitted a de novo request after collecting additional information about study participants to respond to the FDA’s concerns.

Now, the FDA is seeking input from its advisory committee before rendering its final decision.

SOLVD reported overall study results demonstrating a sensitivity of 82.76% (95% CI 76.31-88.05) and specificity of 79.23% (95% CI 73.06-84.54). “However, numerous factors impact the interpretation of test performance and raise uncertainty about the applicability of the observed clinical study test results to the intended use population,” the FDA wrote in its briefing documents ahead of the meeting.

“A device that detects genetic variants that may be associated with OUD could be potentially beneficial in combating the opioid epidemic,” the agency observed.

But genetic risk may not be the biggest factor in predicting OUD risk, the FDA pointed out, noting that “the genetic associations of individual candidate genes identified so far explain only a small portion of OUD risk.” In addition, many individuals with risk factors may never develop the disease, the FDA said.

Unlike risk assessment tools for chronic pain that include routine screening like patient history questionnaires and urine drug tests, genetic tests may have different emotional ramifications and stigmas associated with them, the FDA noted. Risks associated with false-positive and false-negative results also need to be considered, the agency said.

Research studies have also indicated that the 15 SNPs detected by the AvertD are not specific to OUD and may be associated with several other disorders of addiction and mood, the FDA added.

But the over-arching question for the advisory panel on Thursday will focus on the clinical study and whether study participants adequately represent the intended-use population. The FDA voiced a number of potential concerns, including variances in the case report forms used to collect study data, confidence that the study fully excluded people whose index oral opioid exposure was either illicit or for treatment of chronic pain, and the demographic makeup — race, ethnicity, age, and sex — of participants.

In its pre-meeting documents, SOLVD addressed these points and provided additional analyses to support that AvertD study results apply to the intended-use population.

SOLVD also noted that prescribing guidelines call for individual benefit-risk assessments to determine whether opioids are appropriate to manage acute pain.

“Thus, AvertD would fit into current clinical flow, with the principal benefits being providing information to patients and providers to make more informed choices about prescribing opioids for acute pain,” the company wrote.

Congressman Escalates War With PBMs – one of only 2 Pharmacist in Congress/House

Congressman Escalates War With PBMs – one of only 2 Pharmacist in Congress/House

They are hurting healthcare affordability and quality, says Rep. Buddy Carter

https://www.medpagetoday.com/pharmacy/pharmacy/101124

SAVANNAH, Ga. — Representative Buddy Carter, BSPharm (R-Ga.), a pharmacist and former pharmacy owner, on Friday escalated his longstanding battle against pharmacy benefit managers (PBMs), releasing a report critical of the industry and calling for changes in the PBM rebate system.

“What we’re trying to achieve in healthcare is accessibility, affordability, and quality,” Carter said at a press conference in the parking lot of a pharmacy here. “PBMs are hurting accessibility, affordability, and the quality of healthcare.”

Carter issued a report entitled “Pulling Back the Curtain on PBMs: A Path Towards Affordable Prescription Drugs.” The report included stories from patients who had experienced difficulties in accessing their medications due to PBM rules or excessively high drug costs.

The report also urged support for a regulation issued by the Trump administration — but delayed by the Biden administration — that would force drug company rebates to be passed along to patients at the point of sale, rather than being absorbed by the PBMs. And it urged support for legislation now in Congress, such as the Pharmacy DIR Reform to Reduce Senior Drug Costs Act and the Drug Price Transparency in Medicaid Act, that would curb some PBM authorities and force them to be more transparent about their pricing strategies.

At the press conference, speakers — several of whom also appear in Carter’s report — outlined the issues they were having receiving their medications. Jessica Wofford, a nurse who has had Crohn’s disease for 15 years, said that her monthly 1-ml injection of ustekinumab (Stelara) is $24,900. “My insurance company is wonderful in that they will pay $17,000 of this, leaving the rest of the $7,000 to me to figure out how I’m going to pay for it.”

Wofford said she is enrolled in two copay assistance programs to help make up the difference. “I’m enrolled in the second one because I maxed out of the first one in March of this year … And the problem with these kinds of medications is that they’re authorized by your insurance, [but] your insurance will only authorize this through one particular specialty pharmacy. You cannot shop these medications; you cannot go online, unfortunately, and find better prices.”

Terry Wilcox, CEO and founder of Patients Rising NOW, a group of patients advocating for better access to treatment, said that she recently went to a pharmacy to pick up ear drops for her son. “They said, ‘That’ll be $210.'” When Wilcox said the price wasn’t usually that high and that the GoodRx app quoted a price of $80, the pharmacy told her she couldn’t pay that price because it wouldn’t count toward her deductible.

“I was like, ‘Why would I want to pay two and a half times more for something just so that it can count towards my deductible? I want this,'” she said. “So I ended up paying that price. But that’s the shenanigans you go through.”

Elisa Comer, a healthcare administrator, said “there should never be a case where a pharmacist or physician has to tell a mother she can’t [access] medication for a child with juvenile arthritis,” sending the child back into a wheelchair for the next year and a half. “These are true stories,” said Comer. She said that she herself fought so hard with PBMs one year that “I had to give up and go off my medication.”

“I have a message for you PBMs out there: we’re on to you and we’re coming for you,” she said. “These are hills that we are willing to die on. And we’re tired of you hijacking our healthcare. And a word for my chronic illness family — you stay the course, you stay in there and fight. ‘Let’s roll.'” Her last remark a quote from Todd Beamer, a passenger on one of the hijacked September 11, 2001 flights, who said “Let’s roll” before he and some fellow passengers stormed the pilots’ cabin in an effort to derail the hijackers.

Asked for their response, the Pharmaceutical Care Management Association, a trade group for PBMs, sent a statement saying that “Americans consistently reject the use of blame game tactics, especially when real patients’ health and lives are at stake. This is especially true when it comes to blaming PBMs, the one entity reducing costs in the healthcare system.”

“An overlooked reality is that, for the majority of Americans, average patient out-of-pocket costs are actually decreasing thanks to PBM’s [sic] proven ability to negotiate discounts from pharmacies and drug manufacturers on behalf of patients,” the statement said. “Without the affordability and care coordination provided by PBMs, patients’ access to their medications will be limited. We urge other members of the prescription drug supply and payment chain to put down their swords, and join us in making prescription drugs more affordable for more Americans.”

Pharmacy benefit managers inflate drug prices and decrease competition while consumers pay the price. Does the FTC have the medicine to fix it?

Pharmacy benefit managers inflate drug prices and decrease competition while consumers pay the price. Does the FTC have the medicine to fix it?

Pharmacy benefit managers inflate drug prices and decrease competition while consumers pay the price. Does the FTC have the medicine to fix it?

Many have never heard of a pharmacy benefit manager, mega-profitable companies that control what consumers pay for prescription drugs. The FTC’s new probe needs to go far to change the status quo.

One in four people struggle to afford their medications, and eight in 10 people say the cost of prescriptions is unreasonable. Do we really understand why?

The answer: pharmacy benefit managers, or PBMs. If you’re not in healthcare, you’ve likely never heard of these conglomerates, even though some are in the Fortune 10. They impact consumers by controlling and driving up drug prices. After pressure from provider and pharmacy groups, and on the heels of the bipartisan Pharmacy Benefit Manager Transparency Act, the Federal Trade Commission launched a long-overdue investigation into the anti-competitive, anti-consumer practices of the major PBMs, including CVS Caremark, OptumRx, and Express Scripts, who control 80% of the prescription drug market.

How do PBMs work? It’s complicated, on purpose. But the crux is this: PBMs negotiate “rebates” with drug manufacturers to ostensibly lower the price of drugs for consumers on commercial health plans. If you’re a drug manufacturer and don’t pay the rebate, you’re likely excluded from the PBM’s benefit plans. It’s a pay-to-play scheme, and a common practice in this market, leading to allegations that at least one PBM forcibly steered patients to more expensive drugs. Another way PBMs grow profits is adding margin to the price they pay the pharmacy versus what they charge the health plans and patients, a practice known as “spread pricing.” The PBM keeps the spread while raising drugs prices, and any savings comes out of the pockets of pharmacy owners.

What’s more, PBMs operate completely in the dark. There’s no transparency on rebates they get from drug manufacturers, why they cover some drugs but not others, and how they reimburse pharmacies for filling prescriptions. These practices have so inflated the cost of drugs that no one even knows what the real cost is, making all parties in the chain – pharmacists, employers, providers, consumers – completely disempowered. If you’re not mad yet, get ready: PBMs increase their control through bundling, or more precisely, “tying.” The three biggest PBMs are owned by or operate medical payers – CVS/Caremark now owns Aetna, ExpressScripts is now operated by Cigna, and OptumRx is a subsidiary of UnitedHealth Group. They use their newfound drug profits to subsidize their health plan premiums – the argument for vertical integration being, “we’re lowering the cost of healthcare.”

I call it moving money from the left pocket to the right. But the real strategy here is more nefarious. By leveraging their market power in the drug business, bundling this very profitable business with the lower margin medical insurance business becomes an effective tool for blocking new market entrants that would disrupt their lucrative model. The winner is the vertically integrated oligopoly; the loser is consumers.

These conglomerates not only control what drugs are covered and what you pay for them, but even where you can buy them – whether you can use your local community pharmacy or the mail order pharmacy they own and operate. The result is that consumers have been steered away from essential community pharmacies and toward PBM-owned pharmacies, further restricting competition and increasing the PBM’s profits.

Because PBMs have created market distortion in price and prevented a more efficient market from developing, people can’t shop for the drugs they need. Co-pays are sometimes more expensive than paying in cash, patients increasingly can’t afford their medication, and pharmacies are struggling to survive.

So, what can be done? FTC, we look to you: you must nail PBMs on price transparency and tying, bringing real change to the industry through the following requirements:

  • PBMs must disclose to their customers the actual net prices paid and rebates they receive for employer health plans.
  • Make it illegal to limit a patient’s choice of pharmacy providers to the PBM’s owned pharmacy.
  • Enforce existing prohibitions on price tying and bundling when used as a device to block competition.
  • Continue expanding patients’ right to their data, with severe penalties making the cost greater than the rewards for protecting their existing business model.

Anything less will continue the pain at the pharmacy counter. Only through transparency can change come. When people know the price of their drugs and can compare prices across pharmacies and co-pay vs. cash, they can finally take control of their prescription drug experience – and make the right choices for their health.

Pres Biden has costs Medicare folks requiring insulin abt $900 extra on the cost of their insulin over TWO YEARS

back in June 2020  

Trump slashes cost of insulin for Medicare enrollees to $35 a month

This plan would have limited the cost of insulin to Medicare folks to $35/month, starting in Jan 2021

Yes, Biden stopped a Trump order to lower insulin costs, but it would not have helped most diabetics

President Biden took office in Jan, 2021 reversed Trump EO because it would not help that many people… only those on Medicare

The Inflation Reduction Act caps costs for Medicare patients on insulin. Where the push for broader relief stands

In Aug 2022, President signed into law this bills that will provide a copay limit of $35/month on Insulin for Medicare folks – and will not start until 2023.  33% of Medicare folks require insulin to treat their diabetes  And because of this action by President Biden each one of those Medicare folks had to pay – on average –  $446/yr … for their insulin for a EXTRA TWO YEARS

Insulin Rationing Common Among Patients With Diabetes

https://www.medpagetoday.com/endocrinology/diabetes/101257

— More than a million Americans may be engaging in the risky practice, researchers said

More than a million Americans with diabetes may be skipping insulin doses or delaying purchase of the drug because of its expense, said authors of a new study.

Based on data from 982 insulin users participating in the CDC’s 2021 National Health Interview Survey (NHIS), 16.5% reported some form of rationing the drug (95% CI 13.8%-19.6%), according to Adam Gaffney, MD, of Harvard Medical School in Cambridge, Massachusetts, and colleagues.

If that finding is representative of all Americans with diabetes, it could mean more than 1 million patients are rationing insulin with potentially harmful consequences, the researchers wrote in a brief report published in Annals of Internal Medicine.

The survey asked adult insulin users with type 1 or 2 diabetes if they had skipped insulin doses, took less than needed, or delayed buying insulin in the past 12 months to save money. Gaffney’s team considered any positive response an indication of rationing. The most common form of rationing was delayed purchase (14.2%), followed by taking less than needed (10.6%), and skipping doses (9.6%), the study found.

“Several factors likely underlie our findings. Insulin prices in the United States are far higher than in other nations. Moreover, pharmaceutical firms have increased insulin prices year upon year, even for products that remain unchanged,” Gaffney and colleagues said.

“Previous research, media reports of deaths due to insulin omission, and the established pathophysiology of diabetes indicate that cost-related nonadherence to insulin can have serious, even fatal outcomes,” they noted.

Insulin rationing varied among subgroups. Among adults 65 or older, 11.2% reported rationing, compared with 20.4% of younger persons. Among those with higher incomes, 10.8% reported rationing, compared with 19.8% of middle-income and 14.6% of low-income persons. Among Black participants, 23.2% rationed insulin, compared with 16.0% of white and Hispanic individuals.

Rates of rationing were highest among the uninsured (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%), the study found.

Gaffney’s group also investigated whether rationing was associated with feeling “overwhelmed by the demands of living with diabetes” in the past month. Survey responses were dichotomized as “sometimes, usually, or always” versus “rarely or never.” After adjustment for sociodemographic variables, there was a significant association with feeling overwhelmed (prevalence ratio 1.48, 95% CI 1.20-1.76).

In an email to MedPage Today, Gaffney said, “Physicians should be aware of the financial barriers their patients face and prescribe less expensive versions of drugs, assuming it is clinically appropriate and there are multiple, equally effective alternatives.”

“But often there is not, which is yet one more reason why we need fundamental reform in how we procure and provide prescription medications,” he added. “Cost barriers are a tax on illness: we don’t need copays or deductibles on insulin, truly nobody uses more than they need. In my opinion, insulin — like all essential medications — should be free for all.”

Insulin prices are higher in the United States than other countries in part because the federal government does not use its purchasing power to negotiate lower prices, Gaffney said. “So we pay pharmaceutical companies twice as much for their drugs as other high-income nations. Second, we lack a universal healthcare system with full coverage of medications, so patients pay significant amounts out-of-pocket, or even the full sticker price if they are uninsured. It is a dysfunctional system that has caused patient deaths.”

In a statement accompanying the study, the investigators said the findings have implications for ongoing policy debates. The 2022 Inflation Reduction Act capped Medicare enrollees’ copays for insulin at $35 per month. The initial draft of that bill would also have capped insulin costs for people with private insurance, they said.

That provision wasn’t included in the final legislation, however. “As a result, neither the privately insured nor the uninsured — the groups who the new study found most often rationed insulin — have any protection from insulin costs, which can average $1,000 per month or more,” Gaffney’s group asserted.

Limitations of the study included the self-reporting of outcomes and diagnoses, the researchers noted. In addition, the NHIS did not collect data on potential consequences from insulin rationing, such as organ damage or hospitalizations for ketoacidosis.