Is this but just one of the faces that was part of the start of our opioid crisis?

Is this but JUST ONE OF THE FACES… that contributed to the beginning of our illegal Fentanyl poisoning crisis?  He tells Congress that addiction is a DISEASE… He just won:

Jelly Roll Wins New Artist at 2023 CMA Awards, Urges Fans to Keep Going in Rousing Speech

Personally, I am not a big COUNTRY MUSIC LISTENER, most all the musical artists that listen to are DEAD… my musical tastes are from the 1950s & 1960s and early ROCK & ROLL!

Is Jelly Roll the highly visible personality that could also be a valuable spokesperson for the chronic pain community?

https://www.congress.gov/bill/118th-congress/house-bill/3333/text

Medical board publishes new guidelines on prescribing opioids for pain

If you read the hyperlink below, it concerns a practitioner in Calf that back in Nov 2022, his office practice was raided and shut down by the DEA… NOT THE MEDICAL BOARD OF CALIFORNIA. One of this practice intractable chronic pain pts – 61 y/o – Danny Elliott, who was nearly electrocuted to death in 1991 that precipitated his intractable chronic pain. This physician’s office practice was the third pain clinic that Danny was a pt of since 2018 and shut down by the DEA.

Danny & Gretchen lived in Virginia and flew out to California every 90 days to see Dr Bockoff and they had just arrived in CALF for Danny’s quarterly office appt. Suggesting that he had maybe a few day’s worth of Fentanyl patches on hand. After contacting over 12 different pain clinics and being turned away, they BOTH COMMITTED SUICIDE!

This Couple Died by Suicide After the DEA Shut Down Their Pain Doctor

Medical board publishes new guidelines on prescribing opioids for pain

https://www.cmadocs.org/newsroom/news/view/ArticleId/50247/Medical-board-publishes-new-guidelines-on-prescribing-opioids-for-pain

The Medical Board of California recently published a long-awaited update to its opioid prescribing guidelines, which will make it easier for patients to get the care they need while maintaining appropriate safeguards. Importantly, the medical board has clarified that the guidelines are not intended to replace a physician’s clinical judgment and individualized, patient-centered decision-making.

The guidelines are consistent with recommendations from the California Medical Association (CMA), which had urged the medical board’s Opioid Prescribing Task Force  “to use balancing between appropriate risk assessment and ensuring that patients receive individualized care as the guiding principle as you work on this latest update of the guidelines.”

In a letter to the taskforce, CMA noted that previous prescribing guidelines were acutely focused on reducing opioid prescribing to address opioid-related overdose. California already had one of the lowest opioid prescribing rates in the country when the previous guidelines were passed, and has continued to reduce prescribing. The current surge in overdose deaths is related to use of illicit drugs.

The chief of the Stanford University Division of Pain Medicine Sean Mackey, M.D., Ph.D., served as a senior advisor for the medical board’s taskforce and endorsed the revised guidelines.

“I’m a physician scientist, I care for people suffering from chronic pain, many who have intractable pain. Our motivation for revising this document was to learn from the lessons in the past and make it better,” Dr. Mackey said in a letter read at the May board meeting. “We recognize the need to ensure patient access to safe and effective pain management treatment, and at the same time, the need to support physicians providing treatment for people with chronic pain.”

CMA’s requested changes were largely incorporated into the guidelines, including a recognition that the medical board’s Prescription Reviewer Program (formerly known as the “Death Certificate Project”) contributed to physicians being less willing to treat patients with chronic pain.

“We think it is critical to ensure that guidelines recognize the nuance that treating pain requires and acknowledge the complex realities of treating these patients, which include systemic barriers for many patients to access nonopioid therapies or pain specialists and racial and ethnic disparities in care,” CMA wrote in the letter.

The new guidelines address many of CMA’s concerns and adopted CMA recommendations, including:

  • Reinforcing the individualized nature of patient care and making clear that it is not intended to be applied as an inflexible standard by health care entities and is not a law, regulation and/or policy that dictates clinical practice.
  • Clarifying that patients should not be required to sequentially “fail” nonpharmacologic and nonopioid pharmacologic therapy before proceeding to opioid therapy.  The guidelines now state that the basis for initiating opioids should be whether the benefits are anticipated to outweigh the risks of the therapy, rather than by patients having attempted multiple therapies that have inadequately addressed their pain.     

CMA also advocated for removing morphine milligram equivalent (MME) thresholds, because those included in the 2016 Centers for Disease Control and Prevention guidelines “established a ‘one-size-fits-all’ approach to opioid therapy that harmed patients” and perpetuated “the false idea that MME thresholds improve patient care.” The adopted guidelines provide a nuanced analysis of using MME, stressing the need for care being individualized and patient centered and for adequate medical recordkeeping that documents prescribing decisions. The final version removed originally proposed language that suggested an upper limit on opioid prescribing of 90 MMEs.

Fighting rising prescription drug costs

Have You Been Overcharged for Prescription Drugs? We Want to Hear From You

Have You Been Overcharged for Prescription Drugs? We Want to Hear From You

https://www.nytimes.com/2024/01/09/us/overcharged-drugs-pharmacy-benefit-manager.html

The New York Times is looking into pharmacy benefit managers, which play crucial roles in determining which medications your insurance covers and how much you pay.

Credit…Philip Cheung for The New York Times

More voices, better journalism. The questionnaire you are reading is just one tool we use to help ensure our work reflects the world we cover. By inviting readers to share their experiences, we get a wide range of views that often lead to a more deeply reported article. We make every effort to contact you before publishing any part of your submission, and your information is secure.

Most prescriptions in the United States are handled by one of three companies: CVS Caremark, Express Scripts or Optum Rx. These pharmacy benefit managers serve as middlemen between the drug companies that make the medications and the insurance plans that pay for your prescriptions.

These relationships have been in the news because of the high cost of prescription drugs. We want to hear about your experiences with these companies, including whether your medications were covered and how much you paid for them.

We’re also interested in hearing from pharmacists and doctors about their experiences and those of their patients.

We read every questionnaire response, then reach out to a portion of respondents from whom we’d like to learn more. We will not publish any part of your response without communicating with you further. We don’t share your contact information outside the Times newsroom, and we use it only to contact you.

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Planning to Stop That Benzodiazepine? Think Twice

Planning to Stop That Benzodiazepine? Think Twice

Patients who discontinued long-term benzodiazepines had a higher risk of death

https://www.medpagetoday.com/psychiatry/generalpsychiatry/107959

Stopping long-term benzodiazepine treatment was tied to a higher risk of death, according to a comparative effectiveness study using claims data.

An intention-to-treat analysis showed that among people who weren’t simultaneously taking an opioid, the adjusted cumulative incidence of death over 1 year was 5.5% for those who stopped benzodiazepine treatment compared with 3.5% for those who didn’t, according to Donovan Maust, MD, MS, of the University of Michigan in Ann Arbor, and colleagues.

Those who were on concomitant opioids also had a higher incidence of death over 1 year if they stopped benzodiazepines compared with those who continued treatment (6.3% versus 3.9%), they reported in JAMA Network

Mortality risk for those who stopped benzodiazepines was 1.6 times higher than for those who stayed on treatment, with or without concomitant opioid use (95% CI 1.5-1.7 and 95% CI 1.6-1.7, respectively), they reported, noting that all of these risks held in a per-protocol analysis, and were slightly higher.

“Decades of research have demonstrated harms associated with benzodiazepine use, such as fall-related injury and increased risk of overdose — so the assumption has been that less benzodiazepine use would mean fewer harms,” Maust told MedPage Today in an email. “Our analysis suggests that, at least in those who have been receiving stable long-term treatment, risk of mortality appears to be higher in those individuals who have the benzodiazepine prescription stopped.”

“I think the findings speak to the importance of carefully considering the risk/benefit balance of continuing a benzodiazepine prescription,” he added.

Clinicians should be careful about letting their patients become long-term benzodiazepine users, especially if they plan to follow the standard of tapering those patients at some point, Maust added.

“I think it is important to revisit the assumption that tapering stable long-term users should be the default and instead, perhaps, focus on those with clearly elevated risk of harms,” he said.

Philip Muskin, MD, of Columbia University, who was not involved in the study, agreed that the results suggest clinicians should be even more deliberate about starting patients on benzodiazepines.

While the absolute risk shown in the study is small, Muskin said, “it’s real, and I think we need to respect that.”

Some people need and benefit from benzodiazepines, and they appear to be better off remaining on these drugs long-term, Muskin said. Based on these results, clinicians also likely need to diligently monitor any patient who begins to taper off benzodiazepines, even long after they discontinue the treatment, he added.

Increases in overdose deaths involving benzodiazepines have risen over the past several years, leading to a number of FDA actions including a 2016 warning related to co-prescribing with opioids and a 2020 class-wide boxed warning about the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.

The FDA is also developing an evidence-based clinical practice guideline for the safe tapering of benzodiazepines, Maust and colleagues wrote. However, no studies have looked at the risks of discontinuation, they said. Stopping benzodiazepines may be “particularly fraught” as it can have both physiological and psychological implications, they added.

For their study, Maust and colleagues assessed claims data from Optum on patients with a benzodiazepine prescription from 2013 through 2019, totaling 213,011 without concomitant opioids and 140,565 with opioids. Mean age was about 62 and nearly two-thirds in each group were women.

Discontinuation was defined as having no benzodiazepine prescription for 31 consecutive days during a 6-month period after baseline. Patients were followed for about 1 year after baseline benzodiazepine prescriptions.

The researchers also found the risks of secondary outcomes including nonfatal overdose, suicidal ideation, and emergency department use were higher among those who stopped benzodiazepines, whether or not they also used opioids (relative risk 1.2, 1.4, and 1.2, respectively).

The study was limited in that it wasn’t a randomized controlled trial and couldn’t account for all possible confounders. Also, risks may vary by the speed of tapering, which the researchers did not investigate, Maust said. Finally, his team used a strict definition for stable long-term use of benzodiazepines, so this population may have been more likely to experience discontinuation-related distress and adverse effects.

Still, the researchers concluded that the findings are “at odds with the assumption underlying ongoing policy efforts that reducing benzodiazepine prescribing to long-term users will decrease harms,” adding that future work should examine possible mechanisms underlying these findings.

“It is possible that, having become physiologically dependent on benzodiazepines, patients experience adverse outcomes from withdrawal,” they wrote. “Alternatively, patients may experience adverse consequences if they seek alternative sedating substances (e.g., cannabis or alcohol) following benzodiazepine discontinuation.”

Evidence-Based Policymaking: What’s Absent from the Opioid Crisis

Evidence_Based_Policymaking_Whats_Absent

 

How Connecticut is going to resolve the opioid crisis – with an ORANGE STICKER

How Connecticut is going to resolve the opioid crisis – with an ORANGE STICKER

 

https://eregulations.ct.gov/eRegsPortal/Search/getDocument?guid=%7bA040AB8B-0000-C719-9001-39963994F028%7d

As of January 1, 2024, Connecticut state law requires that all controlled substance and opioid prescriptions have a fluorescent warning label attached. Click here to see the regulations, policies and procedures.

HOW STATE’S ATTORNEY GENERALS BILKED $BILLION IN FALSE OPIOID CRISIS SETTLEMENTS

HOW STATE ATTORNEY GENERALS FRABRICATED DATA ANALYTICS, USED DECEPTIVE METHODOLOGIES, TO WRONGFULLY TARGET OXYCONTIN/ PURDUE PHARMA, CVS, WAL-MART, RITE AIDE, et. al., BILKING $BILLIONS IN SETTLEMENT SCAMS (Part-1)

A potential BLACK SWAN EVENT for the chronic pain community

This is the definition of a Black Swan Event from ChatGPT

A black swan event refers to an unpredictable and rare occurrence that has a major impact. The term was popularized by Nassim Nicholas Taleb in his 2007 book, “The Black Swan: The Impact of the Highly Improbable.” The metaphorical black swan was used to describe an event that was considered impossible or highly improbable based on prior observations (as the conventional wisdom was that all swans were white), but that had profound consequences when it occurred.

In the context of finance and economics, black swan events are typically events that are unforeseen, have a major impact, and are often rationalized in hindsight. Examples of black swan events in history include the 2008 financial crisis, the 9/11 terrorist attacks, and the collapse of the Soviet Union. These events are characterized by their extreme rarity, the severe impact they have on systems, and the difficulty of predicting or preparing for them.

The concept of black swan events underscores the limitations of relying solely on historical data and statistical models for predicting future events, as it emphasizes the importance of being prepared for unexpected and rare occurrences that can have far-reaching consequences.

I have made a blog post before about the agreement between 41 state AG’s and the 3 major drug wholesalers to REDUCE the controlled meds that are sold to community pharmacies  Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs    Recently the DEA published proposals to cut Pharma opioid production quotas, as required by law, and had a period for interested parties to make comments, as required by law. I am not aware that the DEA had any requirement to give any serious consideration to the comments made, so it has been reported that they have posted the original proposed cuts as their final decision.

Earlier this year, the DEA stated that <1% of pharma opioids are being diverted, so for the DEA cutting of production quotas will almost guarantee further shortages of opioid meds. The “special twist” that the DEA has put into the process. They are moving from an annual production quotas to a QUARTERLY PRODUCTION QUOTA!

I have read that some of the Pharmas have stated that their cycle of ordering raw material to final production of the medication could be as long as SIX MONTHS!  This suggests that the availability of opioid meds could end up in a highly unpredictable availability.

If this comes to fruition, how many pts are going to be thrown into cold turkey withdrawals, because their meds are not available, and how many times is this going to happen to these pts?  If the DEA ignores the concerns of the pharmas about having quarterly production quotas, would suggest that the DEA has a dedicated purpose to disrupt the medical care of those in the chronic pain community. In no way can they claim that such a disruption has unintentional consequences/outcomes.

All of us can just imagine the anxiety levels of chronic pain pts as their refill date approaches.

Maybe it is time for all involved (pharmas, wholesalers, pharmacies, prescribers) in the treatment of pts dealing with medical issues that require being prescribed controlled meds, to challenge the CSA constitutionality and the DEA’s violation of a federal law that was on the books BEFORE the CSA was signed into law.

This may be an excellent example of our judicial system, where/how Congress can pass a bill and the President can sign it into law and there are no checks and balances if a new law is actually constitutional but can be enforced until some entity challenges it constitutionally in our courts. Some of us remember that the CSA was strongly supported by our then President “tricky dick” Nixon. Who was a known racist, and bigot and wanted to put all hippies and blacks in jail.

Here is the law that may apply:

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

 

What are nitazenes? What to know about the drug that can be 10 times as potent as fentanyl

What are nitazenes? What to know about the drug that can be 10 times as potent as fentanyl

https://www.cbsnews.com/news/nitazenes-fentanyl-substance-use-drug-supply-opioid-death-colorado/

A Colorado overdose death has been linked to a new formulation of nitazenes, a class of powerful opioid analgesics being increasingly seen in the illicit drug market. 

Nitazenes have been around for decades, experts told CBS News, and have been seen in multiple formulations. The person who died in Colorado had used a formulation called N-Desethyl etonitazene. The man died in mid-2023, officials said, but laboratory testing about the substance he overdosed on was not returned until recently.  

It’s believed to be the first time that formulation was found in an overdose death, according to the Boulder County Coroner’s office. 

The coroner told CBS News that while the area has seen a decrease in fentanyl overdoses, use of nitazenes has emerged — which “raises new concerns.” 

Here’s what to know about nitazenes. 

Alex Krotulski, 32, associate director and forensic toxicologist, holds a nitazene powder sample at the Center for Forensic Science Research and Education on Friday, Oct. 20, 2023, in Willow Grove, Pennsylvania. Photo by Joe Lamberti for The Washington Post via Getty Images

What are nitazenes? 

Nitazenes were first developed in the 1950s and early 1960s, said Claire Zagorski, a chemist, paramedic and translational scientist in Austin, Texas. At the time, they weren’t illicit drugs, but were intended to be sold commercially. That never happened, Zagorski said, and in recent years, those original formulations have been used as a backbone by illicit drug manufacturers to make new synthetic opioids amid a crackdown on substances like fentanyl. 

“When you have a backbone of one drug to start with, there is almost limitless ways to modify it,” Zagorski said. Modifications are made by adding substances to that backbone in a laboratory setting. 

The illicit use of nitazenes remains rare, according to Dr. Wilson M. Compton, the deputy director of the National Institute on Drug Abuse. However, testing for nitazenes is not conducted in every overdose death, Compton said, so “we don’t actually know the complete universe of how many deaths are due to these potentially very toxic compounds.” 

Compton said that according to reports by the Drug Enforcement Administration, nitazenes make up “much less than 1%” of the opioids that the agency seizes. However, Zagorski said she expects to see those numbers rise. 

Alex Krotulski, 32, associate director and forensic toxicologist, prepares nitazene powder samples for analysis at the Center for Forensic Science Research and Education on Friday, Oct. 20, 2023, in Willow Grove, Pa. Photo by Joe Lamberti for The Washington Post via Getty Images

“I wouldn’t be surprised if we see more and more nitazenes because they’re still under the radar to a lot of America and it takes time to implement advisories for law enforcement to all get on the same page of what they need to look for,” she said. 

There are multiple forms of the drug circulating, including the N-Desethyl etonitazene version seen in Colorado. Other common formulations include isotonitazenes, metonitazenes, etonitazenes and protonitzenes, according to the Alcohol and Drug Foundation.

“It really is like Whack-a-Mole. Like they just keep coming and coming and coming,” Zagorski said, because of the way the drugs are developed. Now that stopping fentanyl is a national priority, she expects to see more nitazenes being developed by illicit manufacturers and used as authorities to catch up.

“We’re seeing all of these odd chemicals kind of popping up. It’s kind of a divide and conquer strategy, and it’s hard to keep it keep track of things like that,” she said.

Are nitazenes more dangerous than fentanyl? 

Both Zagorski and Compton described nitazenes as “very potent,” but how much risk they pose varies based on the different formulations. N-Desethyl etonitazene and another formulation, etonitazene, are “about 10 times as potent as fentanyl,” Zagorski said. Fentanyl is about 50 times more potent that heroin, according to the DEA

“This is really going to hit with a wallop,” Zagorksi said. 

Compton said that some versions of nitazenes can be even more dangerous than carfentanil, which is a fentanyl compound that is about 100 times more potent than fentanyl itself. 

“They’re even more potent than something that we’re already quite concerned about,” said Compton. 

Nitazenes can also be mixed into other drugs that are sold illicitly, meaning people may not know that they’re consuming something so dangerous, Compton said.

“Nitazenes being mixed with other illicit drugs emphasizes the increased risk of harm or death. Illicit drug suppliers often mix drugs to increase potency or lower costs,” the Boulder County coroner’s office said. It’s not clear if the man who died in Colorado knew he was ingesting N-Desethyl etonitazene.

There also hasn’t been much research into how nitazenes interact with other substances, so there may be unexpected side effects from mixing it with other drugs or alcohol, Compton said. 

Does naloxone work on nitazenes? 

Naloxone, a medication that reverses opioid overdoses and is more commonly known by the brand name Narcan, can reverse an overdose that involves nitazenes, experts said. 

Naloxone is an opioid antagonist that binds to the same receptors in the brain that are affected by nitazenes, Zagorski said. 

Compton said that anyone who experiences a nitazene overdose and is revived with naloxone should seek medical treatment because some nitazines may be long-acting.

“There’s a concern that as the naloxone wears off, they may fall back into a coma and have respiratory depression,” Compton said. 

Naloxone also works on powerful synthetic opioids like fentanyl and carfentanil, and is available over-the-counter.