Halt All Lethal Trafficking of (HALT) Fentanyl Act

Posted on February 18, 2025 by Pharmaciststeve

H.R.467 – HALT Fentanyl Act

passed the House 05/25/2023  https://www.congress.gov/bill/118th-congress/house-bill/467

Grassley, Cassidy, Heinrich Propose Permanent Scheduling Fix for Fentanyl-Related Substances

https://www.judiciary.senate.gov/press/rep/releases/grassley-cassidy-heinrich-propose-permanent-scheduling-fix-for-fentanyl-related-substances

Any bill passed in either House DIES at the end of the congressional session. This bill that Congress is trying to pass is basically revoking the FDA’s approval for a drug’s safe use in humans. 

According to Wikipedia, there is some 100-200 different fentanyl analogs https://en.wikipedia.org/wiki/List_of_fentanyl_analogues BUT there are only 3 of those analogs that are approved by the FDA – 2 in humans and 1 in large animals.

All those other different fentanyl analogs are already ILLEGAL substances. From what I have read it is Fentanyl acetate analog that China and the Mex cartels are selling on our streets.

So I asked www.perlexity.ai

Has Congress ever passed a bill to revoke the FDA’s approval that a medication is safe for being safe for humans

Congress has not passed a bill to revoke the FDA’s approval of a medication that was deemed safe for humans. The FDA’s authority to approve and regulate drugs is generally respected by Congress, and there is no precedent for legislative action directly overturning an FDA safety determination.

The FDA’s role in approving drugs is well-established and protected by federal law. Congress has historically granted the FDA broad authority to regulate drugs and determine their safety and efficacy. This authority is typically not challenged through direct legislative action to overturn specific drug approvals.

While Congress does not typically revoke FDA drug approvals directly, it does have ways to influence FDA actions:

  1. : Congress can pass laws that modify FDA’s regulatory framework or processes3.

  2. : Congressional committees can hold hearings to scrutinize FDA decisions and potentially influence future actions6.

  3. : Congress can affect FDA operations through its control of the agency’s budget.

The issue of FDA drug approvals has recently come under scrutiny in relation to specific medications:

  1. : In 2023, a federal judge in Texas attempted to suspend the FDA’s approval of mifepristone, an abortion medication. This decision was unprecedented and highly controversial, as it marked the first time a court had attempted to revoke approval of a drug the FDA had deemed safe25.

  2. : In 2018, Congress passed and the President signed a “Right to Try” law that allows terminally ill patients to access experimental treatments without FDA oversight. While this doesn’t revoke FDA approvals, it does create a pathway around FDA’s usual regulatory process in specific circumstances4.

  3. : In 2024, some members of Congress introduced a resolution to repeal an FDA rule regarding laboratory developed tests, showing that while Congress doesn’t typically revoke drug approvals, it may act to limit FDA’s regulatory reach in certain areas6.

In conclusion, while Congress has the theoretical power to pass legislation revoking an FDA drug approval, there is no historical precedent for such an action. The recent judicial attempt to revoke mifepristone’s approval was highly unusual and controversial, highlighting the established norm of respecting FDA’s scientific determinations on drug safety and efficacy58.

Citations:

  1. https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf
  2. https://www.texastribune.org/2023/04/07/texas-abortion-drugs-fda-ruling/
  3. https://www.akingump.com/en/insights/alerts/congress-year-end-appropriations-package-brings-fda-legislative-changes-leaves-unresolved-policy-issues
  4. https://www.facingourrisk.org/privacy-policy-legal/advocacy/federal-right-to-try-legislation-passes-signed-by-president
  5. https://www.pbs.org/newshour/politics/5-takeaways-from-the-abortion-pill-case-before-the-u-s-supreme-court
  6. https://finstad.house.gov/2024/5/reps-finstad-and-crenshaw-sen-paul-introduce-resolution-to-repeal-harmful-fda-rule-limiting-access-to-laboratory-developed-tests
  7. https://www.help.senate.gov/imo/media/doc/FDASLA%20manager’s%20amendment%20SXS.pdf
  8. https://www.judiciary.senate.gov/press/releases/congressional-democrats-file-amicus-brief-urging-supreme-court-to-reverse-dangerous-ruling-that-would-restrict-access-to-mifepristone-nationwide-and-upend-fda-approval-process
  9. https://www.fda.gov/news-events/congressional-testimony/antitrust-concerns-and-fda-approval-process
  10. https://www.congress.gov/bill/118th-congress/senate-bill/603/history
  11. https://www.healthindustrywashingtonwatch.com/2024/06/articles/other-health-policy-developments/other-fda-developments/supreme-court-decision-leaves-fda-approval-of-mifepristone-untouched-but-for-how-long/
  12. https://pmc.ncbi.nlm.nih.gov/articles/PMC1808190/
  13. https://www.congress.gov/bill/118th-congress/senate-bill/606/all-info
  14. https://www.kff.org/womens-health-policy/issue-brief/legal-challenges-to-the-fda-approval-of-medication-abortion-pills/
  15. https://www.congress.gov/bill/118th-congress/house-bill/7248
  16. https://www.fda.gov/about-fda/histories-product-regulation/promoting-safe-effective-drugs-100-years
  17. https://www.nytimes.com/2023/04/10/health/abortion-pill-fda.html
  18. https://www.congress.gov/bill/117th-congress/senate-bill/4348
  19. https://www2.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3279703082005.pdf
  20. https://horsford.house.gov/media/in-the-news/supreme-court-unanimously-preserves-access-to-abortion-medication-mifepristone

Answer from Perplexity: pplx.ai/share

Is it just me, or with it being claimed that 30%+ of members of Congress are attorneys and many judges are making decisions that seems to be in conflict with COMMON SENSE?

Since only 1%-2% of known Fentanyl analogs are approved by the FDA as safe to use in humans or animals. Fentanyl was approved ~ 60+ yrs ago after going thru 10+ yrs of clinical trials and has been available for healthcare practitioners to prescribe for all these decades and a judge or Congress should be able to make it ILLEGAL. Since 98%-99% of all known Fentanyl analogs are already ILLEGAL. If they pass this bill, the bottom line is that they will be overruling all the FDA years of clinical trials and practitioners’ experience using this medication, and make those 3 FDA approved Fentanyl analogs classified as a C-1 and thus become an ILLEGAL MEDICATION – like Heroin

Here is a partial list from www.perplexity.ai – notice that several Fentanyl analogs are listed.

Based on the information provided in the search results, here is a list of DEA Schedule I substances:

  • Heroin

  • Acetyl-alpha-methylfentanyl

  • Acetylfentanyl

  • Acryl fentanyl

  • AH-7921

  • Alpha-methylfentanyl

  • Beta-hydroxyfentanyl

  • Butyryl Fentanyl

  • Furanyl fentanyl

  • Isobutrylfentanyl

  • 3-Methylfentanyl

  • LSD (Lysergic acid diethylamide)

  • Peyote

  • Psilocybin (“magic mushrooms”)

  • MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”)

  • Mescaline

  • Marijuana (cannabis, THC)

  • Synthetic marijuana and analogs (Spice, K2)

  • GHB (gamma-hydroxybutyric acid)

  • Methaqualone (Quaalude)

  • Khat (Cathinone, Cathine)

  • Bath Salts (3,4-methylenedioxypyrovalerone or MDPV)

  • Acetorphine

  • Desomorphine

  • Etorphine (except hydrochloride salt)

It’s important to note that this list is not exhaustive, as Schedule I contains numerous other substances135. The DEA classifies these drugs as having no currently accepted medical use in the United States, a high potential for abuse, and a lack of accepted safety for use under medical supervision136.

Citations:

  1. https://www.drugs.com/article/csa-schedule-1.html
  2. https://www.rosalindfranklin.edu/research/centers/research-support-offices/environmental-health-and-safety/controlled-substances/
  3. https://en.wikipedia.org/wiki/Controlled_Substances_Act
  4. https://www.in.gov/health/overdose-prevention/general-information/drug-schedules-1-5/
  5. https://en.wikipedia.org/wiki/List_of_Schedule_I_controlled_substances_(U.S.)
  6. https://www.campusdrugprevention.gov/content/drug-scheduling-and-penalties
  7. https://www.deadiversion.usdoj.gov/schedules/schedules.html
  8. https://www.duffysrehab.com/resources/articles/schedule-of-drugs/
  9. https://dhhs.ne.gov/licensure/Open%20Meeting%20Act%20Docs/APRN%205.20.22%20C1a%20DEA%20-%20Midlevel%20Pracitioners%20by%20State.pdf
  10. https://uscode.house.gov/view.xhtml?req=%28title%3A21+section%3A812+edition%3Aprelim%29
  11. https://www.federalregister.gov/documents/2018/09/28/2018-21121/schedules-of-controlled-substances-placement-in-schedule-v-of-certain-fda-approved-drugs-containing
  12. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/schedule-i-drug
  13. https://americanaddictioncenters.org/prescription-drugs/classifications
  14. https://drexel.edu/studentlife/community-standards/code-of-conduct/drug-free-schools-and-community-act/drug-use
  15. https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
  16. https://www.mass.gov/info-details/learn-about-massachusetts-controlled-substances-registration-mcsr-for-practitioners
  17. https://www.drugs.com/csa-schedule.html
  18. https://www.dea.gov/drug-information/csa
  19. https://www.ncbi.nlm.nih.gov/books/NBK557426/
  20. https://www.chfs.ky.gov/agencies/os/oig/dai/deppb/Documents/KentuckyScheduledDrugList.pdf

Answer from Perplexity: pplx.ai/share

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HALT Fentanyl Act Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act

Posted on February 17, 2025 by Pharmaciststeve

@everyone

This bill has passed the House and there is a similar bill in the Senate but has not been assigned a number yet.  senator young 02172025

The hyperlink above is the letter/email that I sent to Senator Young’s LA who is overseeing this bill. I suggest that you read that letter to help you get up to speed on why making ALL FENTANYL ANALOGS is a bad idea.

PLEASE, JUST DON’T CUT AND PASTE my letter and send it to your two Senators if a politician gets a number of correspondences that are exactly the same thing. they will just believe that the person sending in their correspondence is not their own idea/belief.

This bill means that all Fentanyl products will become a Schedule C-I, basically all Fentanyl products will be ILLEGAL

H.R.467  Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act

https://www.congress.gov/bill/118th-congress/house-bill/467

Kelly, Heinrich, Cassidy, Grassley Introduce Bipartisan Halt All Lethal Trafficking of Fentanyl Act

https://www.kelly.senate.gov/newsroom/press-releases/kelly-heinrich-cassidy-grassley-introduce-bipartisan-halt-all-lethal-trafficking-of-fentanyl-act/

Legislation would permanently place fentanyl-related substances into Schedule I of the Controlled Substances Act, helping law enforcement combat fentanyl trafficking, while advancing scientific and medical research

Senators Mark Kelly (D-AZ), Martin Heinrich (D-NM), Bill Cassidy (R-LA), and Chuck Grassley (R-IA) introduced the Halt All Lethal Trafficking of (HALT) Fentanyl Act to permanently classify fentanyl-related substances (FRS) as Schedule I drugs under the Controlled Substances Act. This permanent scheduling will give law enforcement the tools they need to keep extremely lethal and dangerous drugs off our streets and ensure scientists can research and better understand these substances.

“Fentanyl is devastating Arizona communities, and we need to give law enforcement every tool to crack down on traffickers while supporting scientific research on these substances and treatments,” said Kelly. “By permanently classifying fentanyl-related substances as Schedule I, this bipartisan bill will help prevent these dangerous drugs from ending up in our neighborhoods while saving lives.”

“We’re losing nearly 75,000 Americans each year to illicit fentanyl overdoses. I refuse to accept this reality, and that’s why I’m working to deliver tools law enforcement personnel need to keep deadly fentanyl off our streets and out of our communities,” said Heinrich. “Permanently scheduling fentanyl and its analogues will help federal and local law enforcement crack down on illegal trafficking and allow prosecutors to build stronger, longer-term criminal cases. Our HALT Fentanyl Act will help stop the flow of these deadly drugs into our communities and save lives.”

Background:

The Centers for Disease Control and Prevention (CDC) estimates that there were 107,543 overdose deaths in the United States in 2023. Fentanyl and fentanyl-related substances accounted for nearly 75,000 of those deaths. Since 1999, the overdose crisis has increasingly been characterized by deaths involving these illicitly manufactured synthetic opioids, such as fentanyl-related substances (FRS), whichare commonly sold through illicit drug markets for their fentanyl-like effect, and are often mixed with heroin or other drugs, such as cocaine, or pressed in to counterfeit prescription pills. During this same period, overdose deaths involving synthetic opioids (excluding methadone) increased 103-fold. By comparison, overdose deaths involving heroin and prescription opioids increased 2.5-fold and 4.1-fold, respectively.

Traffickers are continually altering the chemical structure of fentanyl to evade regulation and prosecution, sometimes with tragic results. Since 2013, China has been the principal source of fentanyl, fentanyl-related substances, and the precursor chemicals from which they areproduced. Chinese products are commonly shipped to Mexico and smuggled into the United States illicit drug market. Traffickers have favored fentanyl-related substances to skirt around committing the crime of trafficking fentanyl and fentanyl analogues. In 2023, the Drug Enforcement Administration (DEA) seized nearly 12,000 pounds of illicit fentanyl, including fentanyl powder and more than 78 million pills laced with illicit fentanyl. The 2023 seizures were equivalent to more than 388.8 million lethal doses of fentanyl.

In 2018, as an initial response to this unprecedented crisis, the DEA issued a temporary scheduling order that placed FRS in Schedule I, under the Controlled Substances Act (CSA), after classifying it as an imminent hazard to public safety. Previously, Congress has only closed this loophole temporarily by designating fentanyl-related substances as Schedule I drugs. Congress has extended the FRS temporary scheduling order several times, most recently on December 21, 2024, with a measure that expires on March 31, 2025.

Clear and Enforceable Criminal Penalties for Fentanyl Trafficking:

A permanent scheduling of FRS is necessary to make penalties for criminals clear and enforceable under the Drug Enforcement Administration (DEA), reducing the supply and availability of illicitly manufactured FRS. The HALT Fentanyl Act places the strongest controls and penalties on FRS, which have no accepted medical use and a high abuse potential.

Specifically, the HALT Fentanyl Act will permanently impose the following quantity-based federal trafficking penalties on FRS:

  • Mandatory minimum penalties: 5 years for 10 grams or more (10 years for second offense); and 10 years for 100 grams or more (20 years for second offense).
  • Discretionary maximum penalties: 40 years for 10 grams or more (life for second offense); and life for 100 grams or more.

Expanded Scientific and Medical Research

More closely aligning the research and registration process for schedule I substances, including FRS, with Schedule II substances will facilitate increased FRS research. By accommodating more medical research into fentanyl-related substances, the bill would establish a new, streamlined registration process for research funded by the Department of Health and Human Services (HHS), the Department of Veterans Affairs (VA), or under an Investigative New Drug (IND) exemption from the Food and Drug Administration (FDA).

Specifically, the HALT Fentanyl Act will enhance our understanding of these illicitly manufactured substances by:

  • Allowing researchers in the same institution to participate in multiple scientific studies.
  • Permitting researchers with ongoing studies to examine newly added schedule I substances.
  • Allowing researchers to manufacture small quantities of FRS without a separate registration.

The legislation is cosponsored by Senators Maggie Hassan (D-NH), Ruben Gallego (D-AZ), Roger Marshall (R-KS), Todd Young (R-IN), Steve Daines (R-MT), Eric Schmitt (R-MO), Shelley Moore Capito (R-WV), Catherine Cortez Masto (D-NV), Mike Rounds (R-SD), John Kennedy (R-LA), Jeanne Shaheen (D-NH), and Angus King (I-ME).

Full text of the HALT Fentanyl Act can be found here.

A section-by-section summary of the HALT Fentanyl Act can be found here.

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Epidural Steroid Shots for Back Pain Have Limited Efficacy, Review Shows

Posted on February 12, 2025 by Pharmaciststeve

Epidural Steroid Shots for Back Pain Have Limited Efficacy, Review Shows

https://www.medpagetoday.com/neurology/painmanagement/114196

Promising benefits in some situations, but mixed results in others

Key Takeaways

  • Epidural steroid shots for back pain had mixed results, an AAN review showed.
  • The treatment demonstrated promising short-term benefits for radiculopathy patients.
  • In other situations, benefits were unclear or limited.

Epidural steroid injections demonstrated limited efficacy in reducing back pain and disability, according to a systematic review from the American Academy of Neurology (AAN).

In cervical and lumbar radiculopathies, epidural steroids probably reduced short-term pain and disability, and possibly decreased long-term disability, reported Carmel Armon, MD, of Loma Linda University School of Medicine in California, and members of the AAN guidelines subcommittee in Neurology

In lumbar spinal stenosis, epidural steroid injections possibly reduced short-term and long-term disability, but not short-term pain. There was insufficient evidence to determine whether epidural steroids reduced long-term pain.

There was also insufficient evidence to determine the effectiveness of epidural steroids in cervical spinal stenosis.

“Chronic back pain is common and can negatively impact a person’s quality of life, making it difficult to move, sleep, and participate in daily activities,” Armon said in a statement.

“In our review, studies show epidural steroid injections may have limited efficacy,” he continued. “They may modestly reduce pain in some situations for up to 3 months and reduce disability for some people for up to 6 months or more.”

The review updates a 2007 AAN assessment that reported epidural steroids may improve radicular lumbosacral pain between 2 and 6 weeks after the injection, but they did not improve function or reduce the need for surgery.

The new report — directed to neurologists, physiatrists, pain management specialists, orthopedic specialists, neurosurgeons, spine specialists, and primary care clinicians — incorporated new evidence about epidural steroid injections in cervical and lumbar spinal stenosis and radiculopathies, assessing short-term (3 months or less) and long-term (6 months or more) improvements in pain and disability.

The AAN subcommittee searched databases for randomized controlled trials about epidural steroid efficacy published between January 2005 and January 2021, selecting 90 studies for its systematic review. Trials compared epidural shots against placebo or active control. A panel of epidural steroid experts interpreted the evidence in a clinical context.

Most trials focused on lumbar disease; only two class II studies evaluated cervical radiculopathy and none assessed cervical spinal stenosis. Because the trials used a wide variety of efficacy measures, the subcommittee reported differences based on any measure of success as the success rate difference (SRD).

For radiculopathies:

  • The SRD for short-term pain was -24.0% (95% CI -34.9 to -12.6), with a number needed to treat (NNT) of 4
  • The SRD for short-term disability was -16.0% (95% CI -26.6 to -5.0), with a NNT of 6
  • The SRD for long-term disability was -11.1% (95% CI -25.3 to 3.6), with a NNT of 9

In lumbar spinal stenosis:

  • The SRD for short-term disability was -26.2% (95% CI -52.4 to 3.6), with a NNT of 4
  • The SRD for long-term disability was -11.8% (95% CI -26.9 to 3.8), with a NNT of 8

There’s controversy about the appropriate choice of inactive comparator treatments as a true placebo in clinical trials of epidural steroids, the AAN subcommittee noted. Future studies should use minimal meaningful clinical difference as the measure of efficacy and paraspinal muscle injections of saline as an inactive placebo, the group suggested.

“We found no studies looking at whether repeated treatments are effective or examining the effect of treatment on daily living and returning to work,” noted subcommittee member Pushpa Narayanaswami, MD, of Beth Israel Deaconess Medical Center in Boston. “Future studies should address these gaps.”

 

 

 

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Wisconsin man dies after inhaler cost jumps $500, according to family’s lawsuit

Posted on February 10, 2025 by Pharmaciststeve

According to www.goodrx.com there is a generic for Advair 100/50 and CVS/Target selling price is $47.42 – LESS THAN THE OPTUM COPAY WAS PREVIOUSLY.  www.singlecare.com shows CVS/Target charging $49.92

Wisconsin man dies after inhaler cost jumps $500, according to family’s lawsuit

https://abcnews.go.com/US/wisconsin-man-dies-after-inhaler-cost-jumps-500/story

A young Wisconsin man died from an asthma attack after the price of his inhaler skyrocketed nearly $500, according to a lawsuit filed by his family.

Cole Schmidtknecht, 22, suffered from asthma, a chronic disease, that he treated with an Advair Diskus inhaler that allegedly cost him no more than $66.

That cost changed last year when OptumRx, a subsidiary of United Health Group, stopped coverage for the inhaler Schidtknecht used for a decade, the lawsuit alleges.

On Jan. 10, 2024, Schmidtknecht went to his local Optum Rx-Walgreens pharmacy in Appleton, Wisconsin, expecting to fill his usual prescription when he was advised by Walgreens that his medication was no longer covered by his insurance and would cost him $539.19 out of pocket, according to the lawsuit.

He was given no notice and, the lawsuit said, Walgreens did not offer him a generic alternative “and further told Cole that there were no cheaper alternatives or generic medications available.”

Unable to afford the inhaler, the lawsuit alleges he left the store without it. “Over the next five days, Cole repeatedly struggled to breathe, relying solely on his old ‘rescue’ (emergency) inhaler to limit his symptoms, because he did not have a preventative inhaler designed for daily use,” his family claims in the lawsuit.

On Jan. 15, 2024, Schmidtknecht was driven to an emergency room by his roommate for a severe asthma attack, but “became unresponsive and pulseless in the car,” before reaching the ER according to the lawsuit.

After receiving cardiopulmonary resuscitation (CPR) in the ER, Schmidtknecht spent days in an intensive care unit and never woke up. He was pronounced dead on Jan. 21 after life-supporting care was stopped, the lawsuit states.

His parents are now suing Walgreens, its parent company Boots Alliance and Optum Rx, the pharmacy benefits manager, for negligence.

“Defendant Optum Rx had a duty to not artificially inflate prescription drug prices for medications such as Advair Diskus for insured patients, including Cole Schmidtknecht, making them so unaffordable that patients could not obtain the medications their physicians prescribed,” the lawsuit said.

In a statement to ABC News, Optum Rx said that Schmidtknecht filled a generic Albuterol prescription, an inhaler used to stop asthma attacks, on Jan. 10, 2024, with a $5 copay, adding that the same drug was previously filled in October 2023 by him.

The prescription service said that it “also has available clinically appropriate options and formulary information” for when medication is not covered by a provider.

In the lawsuit, Schmidtknecht’s family claims “Walgreens Defendants failed to exercise reasonable care in that they knew, or should have known, of the unreasonable risk of harm to asthmatic patients, including Cole Schmidtknecht, that would result from their failing to provide him with Advair Diskus or a medically equivalent alternative medication at an affordable price at the point of service.”

Walgreens declined to comment on the litigation when ABC News reached out for a comment.

Just a few months after Schmidtknecht’s death, the makers of Advair, GSK, announced in March 2024 that starting January 2025 the most people will pay out of pocket for their inhaler is $35 a month.

GSK joined other manufacturers of inhalers in capping the out-of-pocket cost for inhalers, something Sen.Bernie Sanders, a Vermont independent who chairs the HELP Committee commented on at the time.

“The three largest manufacturers of inhalers in the world have all committed to cap the cost of inhalers in the United States at no more than $35 at the pharmacy counter,” he said.

Dr. Jade Cobern, MD, MPH, who is board-certified in pediatrics and general preventive medicine, recommended individuals who suddenly see an increase in medication cost or can no longer afford it speak to their provider about alternatives, check for current discounts to lower out-of-pocket costs by using an app like GoodRx or reach out to the manufacturer for assistance or possible rebates.

“If you are struggling to breathe it is imperative that you seek medical help immediately through your doctor, by going to the emergency room or by calling 911,” Cobern said.

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Saving a life is important – especially if it is YOURS

Posted on February 10, 2025 by Pharmaciststeve

An ER nurse says this is the best description of a woman having a heart attack that she has ever heard. Please read, pay attention, and SHARE……….
FEMALE HEART ATTACKS
I was aware that female heart attacks are different, but this is the best description I’ve ever read.
Women rarely have the same dramatic symptoms that men have … you know, the sudden stabbing pain in the chest, the cold sweat, grabbing the chest & dropping to the floor that we see in movies. Here is the story of one woman’s experience with a heart attack.
I had a heart attack at about 10:30 PM with NO prior exertion, NO prior emotional trauma that one would suspect might have brought it on. I was sitting all snugly & warm on a cold evening, with my purring cat in my lap, reading an interesting story my friend had sent me, and actually thinking, ‘A-A-h, this is the life, all cozy and warm in my soft, cushy Lazy Boy with my feet propped up.
A moment later, I felt that awful sensation of indigestion, when you’ve been in a hurry and grabbed a bite of sandwich and washed it down with a dash of water, and that hurried bite seems to feel like you’ve swallowed a golf ball going down the esophagus in slow motion and it is most uncomfortable. You realize you shouldn’t have gulped it down so fast and needed to chew it more thoroughly and this time drink a glass of water to hasten its progress down to the stomach. This was my initial sensation–the only trouble was that I hadn’t taken a bite of anything since about 5:00 p.m.
After it seemed to subside, the next sensation was like little squeezing motions that seemed to be racing up my SPINE (hind-sight, it was probably my aorta spasms), gaining speed as they continued racing up and under my sternum (breast bone, where one presses rhythmically when administering CPR).
This fascinating process continued on into my throat and branched out into both jaws. ‘AHA!! NOW I stopped puzzling about what was happening — we all have read and/or heard about pain in the jaws being one of the signals of an MI happening, haven’t we? I said aloud to myself and the cat, Dear God, I think I’m having a heart attack!
I lowered the foot rest dumping the cat from my lap, started to take a step and fell on the floor instead. I thought to myself, If this is a heart attack, I shouldn’t be walking into the next room where the phone is or anywhere else… but, on the other hand, if I don’t, nobody will know that I need help, and if I wait any longer I may not be able to get up in a moment.
I pulled myself up with the arms of the chair, walked slowly into the next room and dialed the Paramedics… I told her I thought I was having a heart attack due to the pressure building under the sternum and radiating into my jaws. I didn’t feel hysterical or afraid, just stating the facts. She said she was sending the Paramedics over immediately, asked if the front door was near to me, and if so, to un-bolt the door and then lie down on the floor where they could see me when they came in.
I unlocked the door and then laid down on the floor as instructed and lost consciousness, as I don’t remember the medics coming in, their examination, lifting me onto a gurney or getting me into their ambulance, or hearing the call they made to St. Jude ER on the way, but I did briefly awaken when we arrived and saw that the radiologist was already there in his surgical blues and cap, helping the medics pull my stretcher out of the ambulance. He was bending over me asking questions (probably something like ‘Have you taken any medications?’) but I couldn’t make my mind interpret what he was saying, or form an answer, and nodded off again, not waking up until the Cardiologist and partner had already threaded the teeny angiogram balloon up my femoral artery into the aorta and into my heart where they installed 2 side by side stints to hold open my right coronary artery.
I know it sounds like all my thinking and actions at home must have taken at least 20-30 minutes before calling the paramedics, but actually it took perhaps 4-5 minutes before the call, and both the fire station and St Jude are only minutes away from my home, and my Cardiologist was already to go to the OR in his scrubs and get going on restarting my heart (which had stopped somewhere between my arrival and the procedure) and installing the stents.
Why have I written all of this to you with so much detail? Because I want all of you who are so important in my life to know what I learned first hand.
1. Be aware that something very different is happening in your body, not the usual men’s symptoms but inexplicable things happening (until my sternum and jaws got into the act). It is said that many more women than men die of their first (and last) MI because they didn’t know they were having one and commonly mistake it as indigestion, take some Maalox or other anti-heartburn preparation and go to bed, hoping they’ll feel better in the morning when they wake up… which doesn’t happen. My female friends, your symptoms might not be exactly like mine, so I advise you to call the Paramedics if ANYTHING is unpleasantly happening that you’ve not felt before. It is better to have a ‘false alarm’ visitation than to risk your life guessing what it might be!
2. Note that I said ‘Call the Paramedics.’ And if you can take an aspirin. Ladies, TIME IS OF THE ESSENCE!
Do NOT try to drive yourself to the ER – you are a hazard to others on the road.
Do NOT have your panicked husband who will be speeding and looking anxiously at what’s happening with you instead of the road.
Do NOT call your doctor — he doesn’t know where you live and if it’s at night you won’t reach him anyway, and if it’s daytime, his assistants (or answering service) will tell you to call the Paramedics. He doesn’t carry the equipment in his car that you need to be saved! The Paramedics do, principally OXYGEN that you need ASAP. Your Dr. will be notified later.
3. Don’t assume it couldn’t be a heart attack because you have a normal cholesterol count. Research has discovered that a cholesterol elevated reading is rarely the cause of an MI (unless it’s unbelievably high and/or accompanied by high blood pressure). MIs are usually caused by long-term stress and inflammation in the body, which dumps all sorts of deadly hormones into your system to sludge things up in there. Pain in the jaw can wake you from a sound sleep. Let’s be careful and be aware. The more we know the better chance we could survive.
A cardiologist says if everyone who sees this post would Share or re-post, you can be sure that we’ll save at least one life.
*Please be a true friend and SHARE this article to all your friends, women & men too. Most men have female loved ones and could greatly benefit from know this information too! Credit goes to respective owner.
(¯`•.•´¯)¸•´¯`☆ follow us🫴 Inspirations kindness viral `•.¸¸.•´••

Filed under: General Problems | 3 Comments »

The CDC’s Big Mistake

Posted on February 9, 2025 by Pharmaciststeve

Below is a video by the community’s beloved Dr Ibsen. Below that is an article that was published yesterday.  Mark has found himself in a tug of war between caring for long term chronic pain pts and the state of Maine which has apparently unofficially declared the state as an “opioid desert”. Apparently, “they” have decided that all chronic pain pts should only be treated with Subutex (buprenorphine), which is technically classified as an opioid.
During the last administration, I heard time and time again the quote “no one is above the law” and I often stated what I believe should be the end of that sentence. ” except those who are in charge of enforcing our laws”

I was always told that when state and federal law are in conflict, the more strict law is to be observed. Mark is trying to function under policies established by the DEA and federal law and apparently, the Maine AG prefers to function under the state law and his interpretation that a practitioner must be licensed in the state of Maine.

The article below, states that some 40 states have codified the 2016 CDC opioid dosing guidelines and “the law of the land”

I see various groups who have gotten some sort of “corrective law” for chronic pain pts being able to get properly treated passed in a few states. But without getting the original law that was codified from the CDC 2016 opioid dosing guidelines repealed, many in charge of enforcing the laws are able to pick and chose which laws they wish to enforce.  This does not provide the practitioners in the state nor the pts if the new law will provide any safe harbor or protection in getting their medically necessary meds.

  • Estimates: Some experts suggest there may be approximately 300,000 federal statutes when including criminal offenses, agency regulations, and other legal instruments2. However, this number is an estimate and not definitive.

In summary, while the U.S. legal system has extensive documentation like the Statutes at Large and the U.S. Code, no comprehensive tally exists due to the dynamic nature of lawmaking and enforcement.

I once read a quote from someone. “we have 12-15 million laws, rules, regulations…just to get us to obey the TEN COMMANDMENTS”

The CDC’s Big Mistake

https://www.americanthinker.com/articles/2025/02/the_cdc_s_big_mistake.html

President Trump’s first week in office included an order suspending all CDC, HHS, and NIH communications: regulations, announcements, reports, advisories, updates, and online posts.  This aligns with pruning federal bureaucracy.  But silencing these three, of hundreds of agencies, is interesting.

COVID was, for many Americans, their first personal experience of vast, unregulated power imposed by federal agencies.  Without enforcing laws or interpreting regulations, just publishing claims and data can have unrestrained power.

For many Americans, it was shocking and novel seeing suggestions rapidly morph into mandates, while mainstream and social media stripped contradictory evidence and contrary opinions from public discourse.  Some citizens were inspired to push others to wear masks.

But COVID wasn’t the first time government actions that were neither laws nor regulations imposed dire consequences on ordinary, law-abiding Americans.

One agency muzzled by Trump, the CDC, exemplifies far-reaching federal influence.  One example of the profound impact of CDC publications is the 2016 CDC guidelines for pain treatment with opioids.  These guidelines — not regulations, not laws — initiated drastic, ongoing reductions in pain care nationwide.

The guidelines discussed pain patients who had never been prescribed opioids.  The CDC recommended for these patients doses below 90MME per day.  The guidelines didn’t discuss established patients with severe and chronic pain, or the wide genetic variability of sensitivity to pain and sensitivity to opioids.  Although pain is often described as a subjective experience, it’s  observable in animals and people unable to verbalize, including infants, coma patients, and  dementia patients.  Four of the top ten reasons for U.S. E.R. visits are pain (abdomen, chest, head, and general).  Another, back problems, entails pain.  Only for Spock, a fictional alien, is pain merely “a thing of the mind.”

Caution introducing new medication sounds reasonable.  However, variability in pain and opioid sensitivity makes a one-size dosing, even for one subset of patients, or medical condition, unworkable.  Chronic and severe pain often requires much more than 90 MME per day.  Individual morphine tablets of 200mg are legally manufactured and prescribed.

Between 2011 and 2021, U.S. opioid prescriptions were down 40%.  According to JAMA, from 2016 to 2018, prescriptions were down sharply.  This trend began years before the guidelines.

After 2016, many insurers and medical groups, and state governments, drastically reduced prescribing these drugs, even for long established, successfully treated patients.  The 90 MME limit is currently enshrined in laws in 40 states, often applying to all pain patients.  Inpatient palliative care, especially for economically disadvantaged patients, has been significantly reduced.

In 2014, approximately 39.4 million Americans suffered chronic and severe pain.  As of 2024, that number was over 60 million.  In 2016, 1 in 10 U.S. veterans had chronic pain, and after the guidelines were published, veterans complained of insufficient pain treatment and rising veteran suicides.

Facing widespread criticism, CDC expressed surprise that the guidelines had been applied widely and swiftly.  In a 2019 paper, the guidelines’ authors claimed that recommendations had been implemented incorrectly and pain patients were being deprived of necessary medications.  Revised guidelines published in 2022 softened some recommendations, with no effect on post-2016 legislation.

The 2016 guidelines didn’t arise in a vacuum.  Years of prior CDC publications featured flawed data.  There was a detectable inference that legally manufactured opioids prescribed by professionals present a uniquely serious threat not only to patients, but to society.

To illustrate how prescription opioid deaths were supposedly underreported, a 2017 CDC report discussed Minnesota patients with pneumonia and opioid prescriptions who died between 2006 and 2015.  The CDC argued that these should be counted as opioid deaths, not pneumonia deaths, as they had been.

A 2021 report in the medical journal Cureus examined a decade of CDC publications about opioid-linked deaths.  From 2006 to 2016, CDC’s opioid prescription death totals were inflated by counting deaths linked to illicit fentanyl and methadone dispensed for substance abuse treatment.  Methadone prescriptions for pain started declining prior to 2016.  “What is clear from the authors’ inquiry is that, even today, the CDC has no way of determining the actual number of prescription opioid overdose deaths each year.  For more than a decade, the CDC’s erroneous reports went unchallenged while being used by Congress and the Executive Branch as the basis for public policy.”

A 2021 Pain Therapy report shows that death attributed to opioids were over-reported by 20–30% — virtually the same percentage by which the CDC claimed opioid deaths were increasing.  Almost 90% of deaths attributed to opioids included 1–4 other drugs on the death certificate, most frequently benzodiazepines.  A 2021 CDC publication bluntly states that agency efforts to quantify overdose deaths are “falling short.”  As of 2021, the CDC hadn’t complied with Congress’s mandate to improve its methods for tabulating OD deaths.  Whereas one CDC publication reported that opioid deaths were up in 2020, another, in 2023, stated that they were up for the first time since 2018.

Considering the influence wrought by one publication on one subset of patients, data on that subset might be pertinent.  A 2018 study in the BJM studied over two million opioid-naïve patients receiving surgery between 2008 and 2016.  Their subsequent opioid misuse rate was 0.6%.

In 2016, JAMA published data for 641,941 subjects, with no opioid prescriptions for at least a year, receiving major surgery between 2001 and 2013.  The reference sample of 18 million received no surgery.  Depending on the surgery, rates of subsequent misuse ranged from 0.119% following C-sections, to 1.141% for total knee replacement.  For the no-surgery control group, the rate was 0.136%.

Despite revised guidelines, and documented flaws in their opioid data, the CDC continues to publish flawed data.  The influence of the 2016 guidelines continues to spread.  We now have a return of opioid-free surgery, as well as the opioid-free emergency room.

Many medical professionals fear prescribing appropriate opioids from the misguided belief that opioid prescriptions are uniquely lethally dangerous, or fear facing legal battles like the plaintiffs in the Supreme Court Ruan case.

The influence the CDC exerted via publications alone cannot be undone with publications.  At this point, CDC officials could appear in sackcloth and ashes, on social media blast, vigorously repenting of the 2016 guidelines, without affecting the sequela of their work in 2016.

For reasonable pain care, we’d need

  1. legislatures in 40 states to repeal post 2016 laws,
  2. professional medical education to cease depicting prescribed opioids as uniquely dangerous to patients and society, and
  3. the White House to stop financial rewards for Hollywood productions pushing narratives crafted by government drug warriors.

Even if all effects of the 2016 guidelines were entirely reversed, it will do nothing for patients who died by suicide following the sudden withdrawal or forced tapering of their prescriptions.  That number has not been the subject of any federal research.

Filed under: General Problems | 4 Comments »

‘Incredibly irresponsible’: Hims Super Bowl ad downplays risks of compounded drugs

Posted on February 8, 2025 by Pharmaciststeve

‘Incredibly irresponsible’: Hims Super Bowl ad downplays risks of compounded drugs

‘Incredibly irresponsible’: Hims Super Bowl ad downplays risks of compounded drugs

Telehealth provider’s splashy ad underplays risks of medications not approved by the FDA

The latest ad for Wegovy won’t stop anyone in their tracks. “Have you also had trouble with your weight?” a grinning actor says to the camera. “Same!” The blockbuster obesity medication sold by Novo Nordisk can lead to 15% weight loss, more actors claim. But as with many drug ads, more than a minute of its 90-second run time is monopolized by the less savory side of semaglutide: side effects like pancreas inflammation, gallbladder problems, diarrhea, and more.

By comparison, the Super Bowl ad for weight loss medications from direct-to-consumer telehealth company Hims & Hers released Tuesday is optimized to engage and infuriate. Over the refrain of Childish Gambino’s anti-racist anthem “This Is America,” its narrator makes the case that the weight loss industry, including drugmakers, are extracting profits from overweight and obese Americans without really helping them.

The multi-million dollar ad’s message isn’t bogged down by the same litany of disclaimers as Wegovy’s — even though it promotes a compounded version of the same class of medication, known as GLP-1s, as part of its solution to the broken health care system. It’s a paradox of pharmaceutical marketing that has left some health policy and pharmacy experts concerned that compounded medication ads from companies like Hims & Hers, will confuse and mislead patients seeking out obesity care.

“They don’t give ‘fair balance’ to the potential risks and side effects,” said Joey Mattingly, a pharmacy professor at the University of Utah who has written about the marketing and safety concerns around compounded GLP-1s, of the ad. “This is incredibly irresponsible.”

Drugs that are approved by the Food and Drug Administration, like Wegovy, have to meet detailed guidelines for direct-to-consumer marketing: They have to disclose what the drugs are indicated to treat and their most significant risks, and they’re prohibited from overstating benefits beyond the evidence or advertising off-label uses. But “advertising of compounded drugs is not subject to any of the advertising regulations that are typically applicable to prescription drugs,” said Dale Cooke, a consultant who counsels drug companies on product promotion.

That regulatory gray zone has become a topic of concern for public health watchers as compounded GLP-1s have become more widely used, with adoption driven by patients who struggle to access the FDA-approved drugs due to shortages and spotty insurance coverage. These drugs aren’t approved by the FDA, and the agency doesn’t evaluate them for safety, effectiveness, or quality. That means compounded drug ads can’t claim to be safe or effective — in the Super Bowl ad, Hims & Hers more generally refers to its products, which include GLP-1s and other compounded drugs, as “life-changing weight loss medications.” But that also means their ads aren’t required to disclose any of the risks or side effects associated with a drug, including those that belong to GLP-1s as a class and those that apply to compounded drugs specifically.

Hims is looking to capture Americans’ attention with the splashy Super Bowl ad at a time when telehealth providers are facing off against drugmakers over the ability to sell compounded versions of drugs that are not in shortage. Marty Makary, Trump’s nominee to lead the FDA, was an executive of telehealth company Sesame, which is also in the business of prescribing compounded weight loss drugs. 

In a recent analysis published in JAMA Health Forum, Yale researchers pointed out the limitations of marketing for compounded GLP-1s, looking at 79 sites that sell the drugs or prescriptions for them. Just as with Hims’ ad, they found that nearly half of sites marketing compounded GLP-1s didn’t include information about the drugs’ adverse effects, warnings, and contraindications. 

A Hims spokesperson pointed to information about side effects and other risks provided to patients on its website, but did not respond to questions about the company’s standards for sharing safety information in marketing materials specifically. “Every customer touchpoint, including our ads, is designed to be clear, accurate, and accessible so that customers have the digestible information necessary to understand what options are available for the treatment they may be seeking,” said the spokesperson. 

The Yale researchers also found that 37% of sites stated or implied that the compounded GLP-1s they marketed were FDA-approved. The biggest direct-to-consumer telehealth sites, including Hims and Ro, have more consistently labeled their ads with disclosures that their drugs are compounded and therefore not evaluated by the FDA. In the Super Bowl ad, Hims & Hers acknowledges that compounded drugs are not FDA-approved in fine print that appears for three seconds over images of its pills and vials. 

“I had to really squint to see that at the bottom of the video,” said study author Reshma Ramachandran, a physician and health services researcher at the Yale School of Medicine. “Small text for a few seconds of the ad doesn’t I think add a lot in terms of compounding education,” said Ramachandran’s co-author Ashwin Chetty, a medical student at Yale. 

“I’m pretty shocked by this advertisement,” added Ramachandran, “but also am impressed by how cleverly they framed this both in terms of playing to systemic concerns around weight loss and the high prices of novel weight loss medications.” The ad’s imagery hints at the influence of ultraprocessed food in obesity, an area of focus for some of President Trump’s health agency nominees. (Hims was a first-time contributor to Trump’s inauguration fund this year.) And like many ads for compounded GLP-1s, Hims’ Super Bowl spot emphasizes the affordability of its drugs. 

“There are medications that work, but they’re priced for profits, not patients,” the female narrator says over images of a pale-blue pen — the distinctive shade of Novo Nordisk’s Ozempic injector, but with the label blurred out — and clips of a news chyron that reads “weight-loss drugmakers grilled over high prices.” Later, the ad says that Hims’ drugs are “affordable, doctor-trusted, and formulated in the USA.” Along with compounded weight loss medications, Hims prescribes Wegovy and Ozempic.

The Alliance for Pharmacy Compounding, a trade group that includes Hims as a member, shared in an October document that compounders should “avoid promoting a compounded drug based on its price compared to a commercially available drug.” Compounded copies of FDA-approved medications are only allowed in limited circumstances, including when a drug is in shortage, and a lower price isn’t a remit to continue compounding once a shortage has abated. The industry association’s CEO Scott Brunner declined to comment on whether Hims’ ad aligns with that guidance, as a Hims spokesperson claimed. 

Marketing regulations aside, some see Hims positioning itself against the weight loss industry and profit-mongering pharmaceutical companies as disingenuous. Hims not only prescribes medications through its affiliated medical groups, it manufactures and distributes those drugs through compounding pharmacies that it owns. In the first nine months of 2024, it spent nearly half a billion dollars on marketing its drugs and their wraparound care. 

“They are using the narrative/argument that some people make to criticize pharmaceutical companies selling weight loss drugs,” said Chetty, “to then themselves sell weight loss drugs.”

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will BODY COUNT GO UP? During 2023-24 seizures of street drugs laced with carfentanil rose by 720%

Posted on February 8, 2025 by Pharmaciststeve

What specific measures has the Trump administration taken to improve chronic pain management

The Trump administration implemented several measures to combat the opioid crisis:

1. Launched the Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand, a comprehensive effort to address the underlying factors driving the opioid crisis[2][4].

2. Secured $6 billion in new funding over two years to fight opioid abuse[2][4][5].

3. Signed the bipartisan SUPPORT for Patients and Communities Act, which expanded access to evidence-based treatment and support services[3][4].

4. Implemented a Safer Prescribing Plan aimed at reducing opioid prescription fills by one-third within three years[4].

5. Increased funding for State Opioid Response grants, awarding $1.5 billion annually to states and territories[2][5].

6. Expanded access to Medication-Assisted Treatment (MAT), with an estimated 347,000 more Americans receiving MAT in 2019 compared to 2016[5].

7. Increased the availability of naloxone, the overdose-reversing medication, with a 378% increase in monthly dispensing since Trump took office[5].

8. Created a national opioid commission led by then-New Jersey Governor Chris Christie to study the crisis and make recommendations[6].

9. Worked to secure borders and ports of entry against drug smuggling[4].

10. Approved grants totaling over $93 million to help people affected by opioid addiction rejoin the workforce[5].

These measures demonstrate a multi-faceted approach, combining increased funding, legislative action, and policy changes to address the opioid crisis from various angles.

Citations:
[1] https://www.gatewayfoundation.org/blog/trump-administration-opioid-action-plan/
[2] https://www.presidency.ucsb.edu/documents/fact-sheet-president-donald-j-trump-fighting-end-the-opioid-crisis-that-has-devastated-too
[3] https://www.pewtrusts.org/en/research-and-analysis/articles/2018/10/24/president-trump-signs-bipartisan-bill-to-fight-opioid-crisis
[4] https://trumpwhitehouse.archives.gov/opioids/
[5] https://trumpwhitehouse.archives.gov/briefings-statements/president-donald-j-trump-dedicated-administration-fighting-back-opioid-crisis/
[6] https://www.pbs.org/newshour/health/heres-trumps-new-executive-order-means-opioid-addiction
[7] https://leg.colorado.gov/sites/default/files/images/president_trumps_initiative_to_stop_opioid_abuse_and_reduce_drug_supply_and_demand_3-19-18.pdf
[8] https://americanoversight.org/investigation/trump-administrations-response-opioid-epidemic/

Answer from Perplexity: pplx.ai/share

Carfentanil Surge Could Erase Recent OD Declines. And Then Some.

https://www.acsh.org/news/2025/02/07/carfentanil-marches-could-erase-recent-od-declines-and-then-some-49264

During 2023-24 seizures of street drugs laced with carfentanil – a highly potent analog of fentanyl – rose by 720%. Despite the large increase, the absolute number of samples was low. This could change fast as more batches are seized in more places. Carfentanil in street drugs could trigger a disastrous new wave of overdose death.

Last month I wrote about the possibility that naloxone – the only opioid overdose antidote – may no longer work because of carfentanil-laced street drugs. Although the absolute number of carfentanil-laced fentanyl samples seized between 2023-4 was very small, the trend was anything but.

Fig.1 (Left) The number of seized carfentanil-laced fentanyl began to soar beginning in 2013. (Right) The trend is regionalized, at least for now. Source: MMWR

Given the small number of samples, it is reasonable to wonder whether the trend was simply a blip or the beginning of a dangerous trend. Given the following news story from KSL.com, I lean toward the latter. Police seized enough carfentanil to kill roughly 200,000 people.

Carfentanil is really deadly

It’s an understatement to claim that it doesn’t take much carfentanil to kill a person. Since it’s about 10,000 times more potent than morphine (and 100 times that of fentanyl) the estimated lethal dose is 100 micrograms (0.1 mg). It is difficult even to see 100 micrograms of anything. To put this in perspective, consider a grain of rice weighs about 0.3 grams (300,000 micrograms). In other words, a lethal dose of carfentanil weighs 0.033% of a grain of rice; virtually invisible.


Fig. 2 Lethal doses of heroin, fentanyl, and carfentanil. Can you even see the carfentanil? image Credit: Thermo Fisher Scientific – Portable and Handheld Raman Spectroscopy

The magnitude of the seizure

The arrests followed the seizure of 20 grams of illicit carfentanil by Homeland Security. How they detected it is anyone’s guess. It’s not like it was some huge, suspicious package. Quite the opposite. Here are some common items that weigh about 20 grams.

A slice of bread
Four paperclips
A large strawberry
A ballpoint pen
10 US quarters

It would seem that Homeland Security must have had some prior knowledge of what was found inside a bedroom in Provo, Utah. Virtually anything coming from Amazon weighs more than 20 grams.

B-b-b-b-baby, you ain’t seen nothing yet

It’s not just Utah. Not even close. Just in the past month, there have been multiple news stories about carfentanil, including these:

A sharp rise in carfentanil-related overdoses in Ohio
The first carfentanil-related death in Hawaii
A public safety alert was issued in Montana
Carfentanil samples detected in Buffalo, triggering a safety alert
Large shipment seized from Puerto Rico to Staten Island (NYC)
Sharp rise in carfentanil deaths in Illinois
Enough fentanyl to kill 2.5 million people seized on Long Island

Bottom line – carfentanil may erase recent “progress” in reducing OD deaths. If there was any.

The CDC reported a modest decline in drug overdose deaths between 2023-24, but this may not indicate a true reversal of the crisis. It could reflect an artifact of the COVID-era surge in drug use. Why?

Fig. 3 shows the 2023-24 decline, but the red hatched line extends the pre-pandemic trend, suggesting this drop may simply reflect a return to the expected trajectory rather than real progress. This is a visual estimate, not a mathematical projection, and the true trajectory is unknowable.

Fig. 3. Overdose deaths spiked during COVID-19 but have since declined. It is impossible to tell whether the decline is real or simply reflects the COVID surge. The red-hatched line estimates the number of deaths in the absence of the pandemic.

What is certain is that the 720% surge in carfentanil detections poses a serious threat. If this trend continues, overdose deaths will spike again, possibly severely.

Don’t underestimate this new monster. Carfentanil makes fentanyl look like cotton candy.

Filed under: General Problems | Leave a Comment »

Having a Q&A with www.perplexity.ai on pharmacist refusal/denial of filling Pt’s Rxs and not sharing with the pt the clinical reason

Posted on February 5, 2025 by Pharmaciststeve

If a Pharmacist declines/refuses to fill a prescription and only tells the pt that he/she “was not comfortable” and the Pharmacist does not contact the prescriber to clarify any concerns that the Pharmacist has. Did not give the pt any other reason(s). If the pt files a complaint with the appropriate state Pharmacy Board, what could the pt expect from the BOP? Ask the Pharmacist to explain their justification in writing or before a BOP meeting, file an unprofessional conduct charge on the pharmacist’s records or what

If a pharmacist declines to fill a prescription without providing a specific reason and fails to contact the prescriber to clarify concerns, the patient can expect the following actions from the Board of Pharmacy (BOP) upon filing a complaint:

1. Investigation: The BOP will likely investigate the incident to determine if the pharmacist’s actions were in line with professional standards and state regulations[1][4].

2. Request for Explanation: The pharmacist will be asked to provide a written explanation or appear before the BOP to justify their decision and actions[1][4].

3. Review of Conduct: The BOP will assess whether the pharmacist’s behavior constitutes unprofessional conduct[5]. This may include evaluating if the pharmacist:

– Failed to communicate properly with the patient[1]
– Neglected to contact the prescribing practitioner in a timely manner[1]
– Made a decision based on discriminatory assumptions[4]

4. Potential Disciplinary Action: If the BOP finds that the pharmacist’s conduct was unprofessional or violated state regulations, they may:

– Issue a warning
– Impose a fine
– Place a record of unprofessional conduct on the pharmacist’s file
– In severe cases, consider suspension or revocation of the pharmacist’s license[5]

5. Corrective Measures: The BOP may require the pharmacist to undergo additional training or education to prevent similar incidents in the future[2].

It’s important to note that while pharmacists have the right to decline filling prescriptions under certain circumstances, they are generally expected to provide a valid reason and to communicate with the prescriber to resolve any concerns[1][4].

Citations:
[1] https://casetext.com/regulation/nevada-administrative-code/chapter-639-pharmacists-and-pharmacy/trade-practices/section-639753-declination-of-pharmacist-to-fill-prescription
[2] https://nabp.pharmacy/wp-content/uploads/2023/11/Report-of-the-Task-Force-on-Unprofessional-Conduct-and-Disciplinary-Actions.pdf
[3] https://www.idealmedicalcare.org/patient-profiling-are-you-a-victim/
[4] https://hftrialfirm.com/law-blog/can-you-sue-pharmacy-refusing-fill-your-prescription/
[5] https://archive.legmt.gov/bills/mca/title_0370/chapter_0070/part_0150/section_0130/0370-0070-0150-0130.html
[6] https://www.pharmaciststeve.com/cant-say-that-i-didnt-warn-you/
[7] https://www.forthepeople.com/practice-areas/medical-malpractice-attorney/can-you-sue-a-pharmacist-for-not-filling-out-my-prescription/
[8] http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499%2F0465%2FSections%2F0465.016.html

Answer from Perplexity: pplx.ai/share

What steps can a patient take if a pharmacist refuses to fill a prescription without a valid reason

If a pharmacist refuses to fill a prescription without providing a valid reason, patients have several options to address the situation:

1. Request another pharmacist: Ask if another pharmacist at the same store can fill the prescription[2].

2. Transfer the prescription: Take the prescription to a different pharmacy to have it filled[2].

3. File a complaint with the State Board of Pharmacy: Submit a formal complaint against the pharmacist and/or pharmacy for unprofessional conduct[3].

4. Contact the Medical Licensing Board: In some cases, it may be appropriate to file a complaint with the state Medical Licensing Board if the refusal is seen as “practicing medicine”[3].

5. Consult with a healthcare attorney: If the refusal violated patient rights, consider seeking legal advice to explore potential civil litigation options[4].

6. Report to regulatory bodies: File complaints with appropriate governmental agencies that oversee pharmacy practices[3].

7. Document the incident: Keep detailed records of the interaction, including dates, times, and any explanations provided by the pharmacist.

8. Seek a second opinion: Consult another healthcare professional to assess the validity of the refusal[4].

9. Contact patient advocacy groups: Reach out to organizations that support patients’ rights for guidance and support.

10. Review state and federal laws: Familiarize yourself with specific laws in your jurisdiction regarding pharmacists’ obligations and patients’ rights[4].

It’s important to note that while pharmacists have the right to refuse filling prescriptions under certain circumstances, they are generally expected to provide a valid reason and to communicate with the prescriber to resolve any concerns[1].

Citations:
[1] https://www.forthepeople.com/practice-areas/medical-malpractice-attorney/can-you-sue-a-pharmacist-for-not-filling-out-my-prescription/
[2] https://www.singlecare.com/blog/can-a-pharmacist-refuse-to-fill-a-prescription/
[3] https://www.drugtopics.com/view/when-valid-prescriptions-are-refused
[4] https://puschnguyen.com/understanding-your-rights-exploring-the-possibility-of-suing-a-pharmacist-for-refusing-to-fill-your-prescription/
[5] https://blocked.goodrx.com
[6] https://www.nbcnews.com/news/us-news/can-pharmacist-legally-deny-patient-prescription-it-depends-n894871
[7] https://idfpr.illinois.gov/content/dam/soi/en/web/idfpr/faq/dpr/pharmacy-faq.pdf
[8] https://nwlc.org/resource/pharmacy-refusals-101/

—
Answer from Perplexity: pplx.ai/share

What if the pharmacist’s reason for not filling a C-2 Rx because the medication is in back-order from a pharma and/or the pharmacy has no inventory on hand. The pt files a complaint with the state BOP and the BOP asked one of their inspectors to validate that the pharmacy did have a adequate inventory on hand to fill the pt’s C-2 RX. Basically the Pharmacist LIED TO THE PT about not having enough inventory on hand to fill their Rx. This was a opioid med and the pharmacist lying to the pt not having would have caused the pt to deal with withdrawal and elevated intensity of pain. ALL being an INTENTIONAL ACT by the Pharmacist and the Pharmacist should be fully aware of consequences to the pt. What should the pt expect of actions from a state BOP in regards to the Pharmacist’s actions

In this case, where a pharmacist intentionally lied about not having enough inventory to fill a patient’s C-2 prescription for an opioid medication, the patient can expect the state Board of Pharmacy (BOP) to take serious action. The BOP is likely to view this as a significant violation of professional ethics and standards of care. Here’s what the patient can expect:

1. Thorough Investigation: The BOP will conduct a comprehensive investigation, including reviewing inventory records, interviewing staff, and examining the pharmacist’s past conduct[1][2].

2. Disciplinary Action: Given the severity of the lie and its potential consequences for the patient, the BOP is likely to impose disciplinary measures, which may include:

– Formal reprimand or censure
– Substantial fines
– Mandatory additional education or training
– Probation with specific conditions
– Suspension of the pharmacist’s license
– In extreme cases, revocation of the pharmacist’s license[2][5]

3. Documentation: The incident will be recorded on the pharmacist’s professional record, which could affect their future employment and licensing[2].

4. Potential Criminal Charges: Depending on state laws, the BOP may refer the case to law enforcement for potential criminal charges related to endangering a patient’s health or falsifying records[3].

5. Mandated Corrective Action: The pharmacy may be required to implement new policies and procedures to prevent similar incidents in the future[2].

6. Follow-up Inspections: The BOP may conduct more frequent inspections of the pharmacy to ensure compliance with regulations and proper inventory management[2].

7. Restitution: The pharmacist or pharmacy may be required to compensate the patient for any harm caused by the lie, including medical expenses related to withdrawal symptoms or pain management[5].

8. Public Disclosure: Depending on state laws, the BOP’s findings and disciplinary actions may be made public, potentially affecting the pharmacist’s and pharmacy’s reputation[5].

The BOP is likely to view this case very seriously due to several factors:

– The intentional nature of the lie
– The potential harm to the patient (withdrawal and increased pain)
– The violation of trust in the pharmacist-patient relationship
– The mishandling of controlled substances, which are strictly regulated

The patient should expect the BOP to take swift and significant action to address this misconduct and prevent similar incidents in the future[1][2][5].

Citations:
[1] https://www.healthlawalliance.com/blog/pbm-audit-strategy-defending-inventory-shortfalls
[2] https://oig.hhs.texas.gov/about-us/news/avoiding-common-pharmacy-violations
[3] https://robertjdegrootlaw.com/what-happens-when-a-pharmacist-steals-drugs/
[4] https://www.painnewsnetwork.org/stories/2020/4/9/i-was-lied-to-by-a-pharmacist
[5] https://nwlc.org/resource/pharmacy-refusals-101/
[6] https://www.reddit.com/r/ADHD/comments/rmyal6/my_lying_ass_pharmacist_the_aftermath/
[7] https://www.chapmanlawgroup.com/pharmacy-managers-accused-diversion/
[8] https://www.frierlevitt.com/articles/service/pharmacylaw/white-collar-criminal-defense-government-investigations/defending-the-inventory-shortfall-more-complex-than-first-appears/

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What actions should the pt take if the BOP fails to take any of those actions and/or discharges the pt’s complaint without any actions by BOP

If the Board of Pharmacy (BOP) fails to take appropriate action or dismisses the patient’s complaint without any substantive response, the patient has several options to pursue:

1. Appeal the decision: Many BOPs have an appeals process for complaint decisions. The patient should inquire about and follow the official appeals procedure.

2. Escalate to a higher authority: Contact the state’s Department of Health or the agency overseeing the BOP to report the board’s inaction.

3. Seek legal counsel: Consult with a healthcare attorney or medical malpractice lawyer to explore legal options and potential civil litigation.

4. File a complaint with the state’s Attorney General’s office: This office can investigate cases of professional misconduct that state boards fail to address adequately.

5. Contact patient advocacy groups: Organizations focused on patient rights may offer guidance and support in challenging the BOP’s decision.

6. Reach out to elected officials: State representatives or senators may be able to inquire about the case or push for further investigation.

7. Consider filing a complaint with federal agencies: In cases involving controlled substances, the Drug Enforcement Administration (DEA) might be interested in investigating.

8. Document everything: Keep detailed records of all communications with the BOP, including dates, times, and content of interactions.

9. Utilize media outlets: As a last resort, consider sharing the story with local media to bring attention to the issue, but be cautious about potential privacy concerns.

10. File a complaint with professional pharmacy organizations: Groups like the American Pharmacists Association may be able to exert pressure on the BOP to reconsider the case.

It’s important to note that while these steps can be taken, there’s no guarantee of a different outcome. However, persistence and utilizing multiple channels can increase the chances of the complaint being re-examined or addressed more thoroughly.

Citations:
[1] https://www.njconsumeraffairs.gov/ComplaintsForms/Board-of-Pharmacy-Complaint-Form.pdf
[2] https://indymalpractice.com/blog/pharmacy-mistakes-medication-errors-your-legal-rights/
[3] https://www.uniteforsafemedications.org/resources
[4] https://www.vplaw.com/what-is-considered-pharmacist-misconduct/
[5] https://www.reddit.com/r/pharmacy/comments/1ezdm42/board_of_pharmacy_complaint/
[6] https://hftrialfirm.com/law-blog/pharmacy-errors-patient-harm-and-your-legal-rights/
[7] https://www.pharmcompliance.com/post/responding-to-a-state-board-of-pharmacy-complaint
[8] https://amcp.org/sites/default/files/2019-02/Patient%20Rights%20and%20Responsibilities.pdf

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Asking perplexity.ai involuntary reduction of opioid pain meds causing hypertensive crisis blood pressure level

Posted on February 4, 2025 by Pharmaciststeve

There seems to be a “crisis” of lack of clinical studies or collection of specific data points to establish a SOLID RELATIONSHIP BETWEEN OPIOIDS BEING REDUCED and various blood pressure complications and/or cardiovascular adverse events.  MAYBE there is a relationship, but no one has intentionally bothered to collect the data

Asking perplexity.ai involuntary reduction of opioid pain meds causing hypertensive crisis blood pressure level

The search results do not provide specific clinical studies or percentages directly addressing hypertensive crisis levels (200/100+) in chronic pain patients after involuntary opioid reduction. However, some relevant information can be extracted:

1. Opioid tapering has been associated with increased rates of adverse events, including:
– Higher rates of overdose and mental health crises up to 2 years after taper initiation[4].
– Increased emergency department visits and hospitalizations[9].

2. There is a complex relationship between pain, blood pressure, and opioid use:
– Acute pain typically causes an increase in blood pressure[5].
– Chronic pain may lead to persistent elevation in blood pressure over time[5].
– Opioid withdrawal can trigger major adverse cardiovascular events[7].

3. A study found small but statistically significant increases in diastolic blood pressure among patients who underwent opioid tapering[9].

4. Rapid opioid dose reductions (>30% per month) were associated with a fivefold increased risk of overdose in the first month after initiating a taper[1].

While these findings suggest that involuntary opioid reduction can impact cardiovascular health and potentially increase blood pressure, the available data does not provide specific information on hypertensive crisis levels or the percentage of chronic pain patients experiencing such severe elevations in blood pressure after involuntary opioid reduction.

Citations:
[1] https://pmc.ncbi.nlm.nih.gov/articles/PMC9509303/
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC6957663/
[3] https://med.umn.edu/news/u-m-medical-school-researchers-find-blood-pressure-medications-impact-brain-function
[4] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793293
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC8033897/
[6] https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf
[7] https://www.jacc.org/doi/10.1016/j.jacc.2020.11.002
[8] https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[9] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2801014

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