LIES and other “political facts” about the opiate crisis

Posted on November 8, 2022 by Pharmaciststeve

Fear, Loathing, and Fentanyl Misinformation

https://www.medpagetoday.com/opinion/second-opinions/101577

Misleading fentanyl narratives are pervasive and cause very real harm

“‘Think about this,’ (East Liverpool Ohio Chief of Police) Lane told ‘Inside Edition.’ ‘Nobody sees (fentanyl) on his shirt. He leaves and goes home, takes off that shirt, throws it in the wash. His mom, his wife, his girlfriend goes in the laundry, touches the shirt — boom. They drop. He goes home to his kid. ‘Daddy! Daddy!’ They hug him — Boom. They drop. His dog sniffs his shirt, it kills his dog. This could never end.'” – Washington Post

“She said her body went numb within 10 minutes after picking up the dollar. She said she could barely talk or breathe before passing out…(they) believe the dollar she picked up was laced with fentanyl.” – WSMV4

“Deputy Faiivae tested three bags found in a suspect’s car using a portable narcotics analyzer in the back of the patrol vehicle…the first two bags tested presumptive positive for fentanyl…when he stood up ‘he began to feel lightheaded and fell down’…he was administered four doses of Narcan…Deputy Faiivae’s field training officer recounted that Deputy Faiivae ‘was OD’ing the whole way to the hospital.'” – New York Times

The looming specter of fentanyl in news reports has become inescapable. But more often what is shared is misinformation rather than accurate facts.

These aren’t just isolated cases of bad reporting. It’s a societal problem. On a recent episode of the primetime CBS show, NCIS: Hawai’i, a sailor with abrasions on his feet steps in a tide pool containing a bag of fentanyl and is shown dying from a fentanyl overdose in under a minute.

I have studied fentanyl misinformation since 2017. While misinformation is problematic for obvious reasons, misinformation about drugs, like fentanyl, is harmful. The U.S. continues to break records in drug overdose death numbers year after year, from thousands of deaths per year in the early 2000s to a now consistent 100,000 plus American lives lost each year in preventable deaths. The biggest driver of these deaths is fentanyl.

Nowadays fentanyl is a boogeyman, something people fear can injure them at any time. But fentanyl is neither good nor bad, it is literally just a molecule. It is simultaneously an invaluable medical therapeutic and the primary cause of record-breaking overdose deaths. Notably, fentanyl is not a new drug; it has been FDA-approved since the 1960s and in street drugs since at least the 1970s, and it is well-studied and well-understood. The problem with the publicized information is that the people who speak the most and the loudest — and dominate reporting — appear to neither have studied nor understand fentanyl.

The “fentanyl exposure” myth has dominated headlines more than anything else: people claiming to have experienced “overdoses” from touching unknown powders that they believe to be fentanyl or from simply being in close proximity to some substance they believe to be fentanyl — even when it turns out not to be fentanyl. This was the case with the woman who picked up the dollar bill (she tested negative for fentanyl) and the Sheriff’s Deputy who collapsed after handling an open bag of powder.

We know that fentanyl does not pose a risk through accidental skin contact or proximity. It does not readily absorb through the skin, and even under the most intentional conditions cannot absorb in any rapid time frame. It also does not aerosolize or enter into the air to be inhaled or otherwise ingested. The only way fentanyl can cause overdoses is if it is injected, snorted, or otherwise ingested. Even the CDC, no stranger to communications issues, has had to recently address this myth in light of law enforcement continuing to perpetuate a dangerous and impossible narrative.

Yet the misleading reports continue — and not without consequences. They have inspired a lucrative market of scammy products from “fentanyl-proof” gloves to expensive HAZMAT responses, all of which are nonsensical and unnecessary. But this myth has far worse harms than scamming people and wasting taxpayer dollars. This myth — a scientific impossibility — has led to a reduced or delayed response to real fentanyl overdoses where time is critical and to criminal charges and incarceration for the imaginary crime of “fentanyl exposure.” These are very real harms, and this myth is the justification behind further harming a vulnerable population that is already suffering and dying at astronomical rates.

More recently, a new fentanyl myth has arisen regarding the idea of “rainbow fentanyl,” which the U.S. DEA described as “brightly-colored fentanyl” being made to “target young Americans.” The DEA did not provide any evidence to support this, and has declined to substantiate their own claim even to major media sources. It is worth noting that before the DEA director made this announcement, “rainbow fentanyl” was not even a searchable term. However, less than 90 days after this announcement there were nearly 1,400 news articles about “rainbow fentanyl” and a proposal from Congress to give the DEA almost $300 million dollars “to fight rainbow fentanyl,” something that nobody in the world of substance use and addiction had ever heard of. This is also not the only time in recent memory that the DEA has denied objective scientific facts to mischaracterize illicit fentanyl products to expand their authority.

The “rainbow fentanyl” in the DEA press release was actually illicit pills made to look like pharmaceutical oxycodone tablets, which come with added color even when made by legitimate pharmaceutical companies. Even DEA press releases going back years show nearly identical fake pills of multiple colors containing fentanyl without such concerns. Yet, this captured public attention in proximity to Halloween and became the most recent iteration of the very extensively debunked “Halloween sadism” myth. For obvious reasons, children are not ideal customers for drug dealers; yet, completely illogical reports that expensive fentanyl pills would be given out for free to unsuspecting trick-or-treaters continued.

Our society has long had strong — and strongly divided — opinions on substance use but we should all agree on objective facts. Not only are fentanyl myths pervasive, but they also cause very real harms and distract us from having more meaningful conversations, like how to truly prevent pediatric overdoses and which evidence-based public health measures can address our drug overdose problem. Clinicians and researchers like me are ignored for sensationalist narratives, while Americans continue to die entirely preventable deaths. While we assume that our leaders, and the people speaking most vocally about this topic, would not do so without having credible knowledge, profiteers, politicians, and others have been capitalizing on the moral panic around fentanyl without addressing problems meaningfully or even realistically. With record drug overdoses showing no sign of slowing, it is time to listen to experts and listen to the science instead.

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Doctor admits health care fraud at pain management center

Posted on November 7, 2022 by Pharmaciststeve

I have often posted over the years, that forcing a pt to get ESI injections was a violation of part of the Sherman Antitrust Act, called Tying Commerce https://en.wikipedia.org/wiki/Tying_(commerce)     

Basically, it is illegal to force someone to purchase something they don’t want in order to be able to buy something that they do want.  Also, charging any insurance for products/services that is not medically necessary is considered INSURANCE FRAUD.

There are a couple of countries that have made it illegal to administer  corticosteroids via ESI’s.  Our FDA and Pfizer who is the pharma of the corticosteroids commoningly used DO NOT RECOMMEND corticosteroids being administered by ESI.

there is also a federal law that prohibits any inducement to a pt to cause Medicare/Medicaid to incur an expense.  I guess that it was too much trouble for the DOJ… to pursue all the laws that were being violated.

Doctor admits health care fraud at pain management center

https://www.post-gazette.com/news/crime-courts/2022/11/07/health-care-fraud-guilty-plea-john-keun-sang-lee-jefferson-pain-and-rehab/stories/202211040095

A former physician has pleaded guilty in federal court to a health care fraud charge associated with the pain management practice Jefferson Pain and Rehabilitation Center, the U.S. Attorney’s office in Pittsburgh announced.

John Keun Sang Lee, 79, of Peters, pleaded guilty Friday to one count of health care fraud before United States District Judge W. Scott Hardy.

In connection with the guilty plea, the court was advised that between in and around May 2016 to in and around October 2020, Lee submitted claims for steroid injections to Medicare and Medicaid that were neither reasonable nor medically necessary, a press release stated.

“According to former patients and employees, Lee required patients to submit to steroid injections, even when patients reported that the injections were not helping but rather causing them more pain and other injuries. Lee also instructed employees to withhold patient medication if patients objected to the injections. In order to justify billing insurance companies for the medically unnecessary injections, Lee directed staff to use templates indicating that patients received 80% relief from prior pain injections” the release said.

Judge Hardy scheduled sentencing for March 7, 2023.

As part of his plea agreement, Lee has agreed to pay $264,730 in restitution to the United States Department of Health & Human Services and $153,230 to the Pennsylvania Department of Human Services for losses associated with the fraudulent billings. Lee also has agreed to voluntarily surrender his medical license and DEA registration and not to maintain any ownership or management interest in any medical clinic or facility.

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Senate Report Decries Medicare Advantage Plan Marketing Deception

Posted on November 7, 2022 by Pharmaciststeve

Senate Report Decries Medicare Advantage Plan Marketing Deception

https://www.medpagetoday.com/special-reports/features/101583FF

Frustrated, confused, embarrassed enrollees often delay care after being “scammed,” report notes

Widespread Medicare Advantage (MA) marketing scams and deception often result in beneficiaries getting switched — without their knowledge or consent — to plans that don’t cover their providers or their needs, according to a new report from the Majority Staff of the U.S. Senate Committee on Finance.

Committee Chairman Ron Wyden (D-Ore.) and fellow members give examples of “bait and switch” schemes, “aggressive” and “sneaky tactics,” and “predatory actions,” such as agents approaching seniors in grocery stores and giving out “false and misleading information,” or distributing materials that falsely imply they’re from Medicare or another federal agency rather than a private company.

Marketing Scams

The majority committee collected complaints from 14 states, Medicare advocacy organizations, and federally funded State Health Insurance Assistance Programs (SHIP), “painting a consistent national picture” of deceptive practices.

They noted that MA plan advertisements are not harmless. “Some people who fall victim to marketing and enrollment scams delay care because of confusion over their benefits and coverage instability. Many feel frustrated and embarrassed that they were scammed,” they wrote.

“False and misleading marketing advertisements and fraudulent sales practices undermine access to care and the trust beneficiaries have in the Medicare program,” they added.

David Weil, program manager for the SHIP-equivalent program in San Diego, agreed with the committee’s report, noting that “the problem of misleading and false advertising has plagued the Medicare Advantage landscape for the 15 years I’ve been involved with the program.”

“Coupled with unethical and unscrupulous brokers, complaints from beneficiaries always seem to spike in January and February after they discover that what they were told during the annual election period or thought would be the case turns out not to be true. Our counselors then find themselves trying to undo the harm and get them back on the path to positive health outcomes,” he told MedPage Today.

Despite these deceptive practices, the Centers for Medicare & Medicaid Services (CMS), which has reviewing authority over MA marketing materials, made “only one enforcement decision” related to deceptive marketing practices since September 2017. That 2019 action, against Solis Health Plans of Miami, resulted in a fine of only $41,552.

Joe Namath Deception

The report singles out complaints regarding particularly disingenuous television ads advertising the “Medicare Coverage Helpline,” which feature celebrities such as former football star Joe Namath.

“In the ad, Mr. Namath says, ‘get what you deserve,’ and ‘the benefit that adds money back to your Social Security check.’ After numerous lawsuits, the ad was recently updated to comply with current CMS regulations,” the report noted. “However, it still fails to mention basic information about the MA program, including that not all providers are in-network and was only recently updated to mention that benefits vary by zip code.”

Particularly troublesome for Tatiana Fassieux, an educator with California Health Advocates, a SHIP-affiliated program in Northern California, is the “explosion of new plans without premiums, deductibles, or even co-pays,” which are proving to lack providers in clients’ networks. The TV ads reach large geographic areas, and often enroll beneficiaries in plans with no providers in their county, thus saddling counselors with “the task of unraveling the mess.”

“Even though CMS has placed more restrictions on TV and other media marketing for 2023, third-party marketers do not care!” she told MedPage Today.

A 2020 investigation by the House Committee on Energy and Commerce found that 14,000 third-party agents and brokers across 40 states were tied to the company sponsoring the helpline ads, TogetherHealth, a subsidiary of Benefytt Technologies, formerly known as Health Insurance Innovations, or HII.

According to the report, “HII’s operation and business structure incentivizes third-party agents and brokers to actively target vulnerable consumers seeking comprehensive health coverage.”

Through 1-800 calls and online plan finder tools, TogetherHealth generates “leads” for thousands of agents and brokers with the names of prospective MA beneficiaries in what the report called “a tangled web of actors that regulators must unravel to monitor and regulate MA plan marketing.”

For example, in Missouri, “an elderly consumer in a long-term care facility and without the capacity to make her own decisions called the number advertised on television. During the call, she was switched from one plan to another.”

Trump Regulatory Rollbacks

The report specifically blamed the Trump administration for rolling back “commonsense marketing regulations” in 2018, when they limited the types of materials under regulation and removed the requirement that marketing materials include the consumer grievance and appeals process.

Those regulatory relaxations also removed the requirement that plans terminate unlicensed agents and brokers and notify the enrollee, making it more difficult for regulators to identify bad actors, the report said. It also prevented enrollees from knowing that they could be eligible for a special enrollment period to get into a more suitable plan if they had previously enrolled based on misinformation.

Additionally, on Jan. 19, 2021, 1 day before the end of Trump’s presidency, his administration expanded allowable marketing activity into healthcare settings, including waiting rooms and common entryways.

The report did not mention one common problem many MA enrollees face when they realize they’ve been enrolled in a plan that does not provide the benefits they expected, or requires high co-pays or deductibles, such as hundreds of dollars in co-pays for each day of hospitalization. If, after a trial period of 1 year, they try to disenroll and apply for a supplemental plan to pick up those costs, their health conditions may lead to them being rejected, thus incurring $1,600 in deductibles for each day of hospitalization, as well as 20% co-pays for most other encounters.

Regulatory Fixes

The report recommended five actions to stop deceptive practices:

  • Reinstate requirements loosened during the Trump administration, such as reinforcing prohibitions against educational events and marketing events happening on the same day in the same place
  • Monitor disenrollment patterns and use CMS’s enforcement authority to hold “bad actors” accountable
  • Require agents and brokers to review their clients’ prescription drugs and regularly visit health providers to ensure that the plan meets beneficiaries’ needs, considered “best practices”
  • Implement robust rules around MA marketing materials and close regulatory loopholes that allow cold-calling. CMS should prohibit MA plans from contracting with marketing organizations, agents, or brokers who design materials that include the use of Medicare in the business name, or suggest they are from Medicare. The agency should also prohibit MA plans from contracting with agents and brokers who purchase lists of leads, especially from online “bait and switch” ads. CMS should review its agent/broker compensation model “to ensure that agent/broker incentives align with a beneficiary’s interests and do not distort the incentives for choosing” one plan over another
  • Support unbiased sources of information for beneficiaries, including sufficient resources for the SHIP and the Senior Medicare Patrol program, described as “valuable partners in … identifying local and national actors who are misleading or deceiving beneficiaries”

“Every senior deserves clear, accurate information that empowers them to be active choosers about their Medicare options and we commend the Senate Finance Committee’s efforts to this end,” said Mary Beth Donahue, president and CEO of the Better Medicare Alliance, which represents more than 180 provider groups, health systems, and health plans.

“We strongly agree with the report’s recommendation that CMS use its enforcement authority to hold bad actors accountable and we welcome increased direct oversight of third-party marketing organizations, whose activities are currently regulated differently from the marketing conducted by health plans,” she added. “Medicare Advantage health plans’ marketing communications today are subject to a clear set of guidelines, including requiring approval from CMS. If outlier third-party marketing entities fail to maintain the high standard of accuracy and trust that Medicare beneficiaries deserve, those entities should face serious consequences.”

A recent MedPage Today report showed how brokers earn double the commission for enrolling a beneficiary into an MA plan compared with traditional Medicare/Medigap plan.

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CVS Health to sell Omnicare

Posted on November 5, 2022 by Pharmaciststeve

The last few years that I worked as a pharmacist, I worked as a temp pharmacist and one of the locations that I worked at, was one of Omnicare’s LTC pharmacies. When I had my own independent pharmacy, we serviced nursing homes.  I left working as a pharmacist before CVS bought Omnicare.  I worked a lot of closing shifts and we used both a local Walgreens and CVS for picking use meds that we had a order for that the pharmacy was out of stock.   I don’t remember the exact time frame but at some point… The Omnicare was told by CVS that they did not want to be a backup pharmacy for Omnicare.

Them selling Omnicare off, does not surprise me. When you are providing services to nursing homes… you do not have not control over the cost of deliveries or the number of deliveries that a particular facilities requires. From what I have seen/heard about how CVS functions… they are very focused on controlling costs.

This quote from the article: it is “determined that its LTC business was no longer a strategic asset.. that sounds like “corporate speak” for the Omnicare division was either losing money or they believe that they can take the money generated from selling the division and make more money putting it to work in some other business.  I am really surprised that they kept this business this long.

CVS Health to sell Omnicare

https://drugstorenews.com/cvs-health-sell-omnicare?oly_enc_id=1561H7059134A4V

In an SEC filing on Wednesday CVS said that it is “determined that its LTC business was no longer a strategic asset, and during the third quarter of 2022 committed to a plan to sell.”

CVS Health announced on Wednesday that it plans to sell Omnicare, its long-term care pharmacy business. The Woonsocket, R.I. company reported a $2.5 billion loss related to Omnicare in the third quarter.

Omnicare serves senior living communities, skilled nursing facilities and Programs of All-Inclusive Care for the Elderly.

“We continue to evaluate our portfolio strategically and are making decisions around assets that don’t fit into our portfolio strategically. Omnicare is a good example of that,” Karen Lynch, president and CEO, said Wednesday morning during the Q&A with analysts on the company’s third-quarter earnings call.

In a Securities and Exchange Commission filing on Wednesday CVS said that it is “determined that its LTC business was no longer a strategic asset, and during the third quarter of 2022 committed to a plan to sell.”

What’s next for CVS?

During the Q&A with investors, Lynch also said, “We will continue to evaluate our options on primary care. And as I said, we believe that we need to do M&A, and we continue to evaluate those options in the marketplace.”

CVS acquired Omnicare in 2015 in an approximately $12.3 billion deal.

 

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When a process/guidelines has very little valid medical rational

Posted on November 5, 2022 by Pharmaciststeve

I’m going to use an analogy to make my case.  I remember from plane & solid geometry that it takes 3 points of support to a horizontal solid plane to make it stable.   For those of you who never had to take a plane & solid geometry course, think how easy/hard it would be to sit on a stool that only had one or two legs supporting it compared to a stool that would have three legs.

Both versions of the CDC guidelines (2016 & 2022) is primarily based on three medical premises that has – at best – very poor/inadequate medical evidence supporting their processes and/or conclusions.

First is the fact that the CDC guidelines used in both versions, studies that were mostly rated “3” or “4” in the quality of the data used to come to the conclusion of the study.  A study with a rating of “1” is considered highly reliable and those rated “3” or “4” is consider poor and/or unreliable regarding the data used and the conclusions.

After the 2016 guidelines were published I have seen numerous times where other professionals have questioned the use of such poorly rated references used to support the conclusions for the 2016 guidelines.; Yet, it would appear that the FIVE “experts” seemingly chose to use the same references for the 2022 guidelines.  Does this mean that using more reliable references would not support the desired conclusions to support the 2022 guidelines ?

No one seems to questions that FIVE “experts” are given credit for the creation of this 200+ page set of guidelines, and of the 20 +/- pages of references and footnotes, ONE WHOLE PAGE has abt 12 references with the first name on each referenced article being the same person who is “ONE OF THE FIVE EXPERTS” who created the 2022 CDC dosing guidelines.  Is that a blatant conflict of interest or just self-serving ?

https://www.cato.org/blog/cdc-replaces-flawed-2016-opioid-prescribing-guideline-flawed-2022-opioid-prescribing-guideline

“The Guideline recommendations are still primarily based on “Type 3” and “Type 4” evidence ”

Earlier this year Chuck Dinerstein, MD, MBA published a article that is basically the genealogy of the MME system.  Clearly documenting that this system has no science nor double blind clinical study supporting its conclusions.

https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154

One of the oldest internet published MME conversion programs https://globalrph.com/medcalcs/opioid-conversions-calc-original-single-agent/

has the following footnotes:

Published equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring. 

bulletFactors that must be addressed during the conversion process include: Age of the patient or presence of coexisting conditions. Use additional caution with elderly patients (65 years and older), and in patients with liver, renal, or pulmonary disease.

bullet Conversion ratios in many equianalgesic dosing tables do not apply to repeated doses of opioids.

bulletThe amount of residual drug in the patient’s system must be accounted for. Example: fentanyl will continue to be released from the skin 12 to 36 hours after removal of the patch. Residual effects from discontinued long-acting formulations should also be assessed before converting a patient to a new opioid.

bullet The use of high but ineffective doses of a previous opioid may result in overestimation of the converted opioid.

bullet Ideally, methadone conversions (especially patients who were previously receiving high doses of an opioid) should only be attempted in cooperation with a pain specialist or a specialist in palliative medicine.

bullet Meperidine should be used for acute dosing only and not used for chronic pain management (meperidine has a short half-life and a toxic metabolite: normeperidine). Its use should also be avoided in patients with renal insufficiency, CHF, hepatic insufficiency, and the elderly because of the potential for toxicity due to accumulation of the metabolite normeperidine. Seizures, confusion, tremors, or mood alterations may be seen. In patients with normal renal function, total daily doses should not exceed 600mg/24hrs.

I found no mention, in the either sets of guidelines, that pharmacogenomic DNA testing, to determine if the pt is a fast/ultra fast metabolizer which would be valid justification of the pt’s in need of higher single doses, more frequent dosing and/or higher total mgs/mcgs per 24 hrs.

Third, everyone needs to watch this video https://stanford.zoom.us/rec/share/F6IC_Sitiu4lmGQgBbD9wVvOb5iG9Eal7fnJrqC2G2lMMEjDM8H4mv4D_hOjD6mY.jqBbyLkUm9RvzhKS

The presenter, attorney Dr. Jennifer Alva indicates that the PDMP/Narxcare reports contains a high percentage of unreliable data points on pts that results in bad/false Narxcare score, resulting in a pt  being falsely labeled as having a “high score” of being at risk of overdosing or dealing with OUD.

She also suggests that most states have turned their PDMP record keeping over to Experian/Bamboo Health/Narxcare.  I recently read where all of the medical databases that Bamboo Health maintains has been mover “off-shore “. Somewhere  “across the pond”, where our HIPAA rules are not applicable. Apparently leaving this company to be able to sell our health data to any entity willing to pay for it. I guess that the DEA no longer needs a court warrant to search PDMP’s databases and they can go on a “data fishing expedition” all they want, without the constraints of our legal system and our laws.

Here is a post on my blog displaying a typical Narxcare report format Images from a Narxcare report – PLEASE SHARE

Please note that apparently Bamboo Health is using a LME value ( Lorazepam Milligram Equivalents)

In doing some research… appears that an association of Pharmacists: The American Association of Psychiatric Pharmacists     may have created this LME system. appears that it may have been first published in Aug 2014

and here is a hyperlink to a full chart of LME’s  https://deprescribe.web.unc.edu/wp-content/uploads/sites/20194/2020/04/Benzo-Equivalency-Table_UNC.pdf

It seems that the entire prescribing/dosing of opiates seems to be supported not much better than trying to sit on a stool with legs being made out of “cooked spaghetti “. Yet, it seems like a lot of various entities in healthcare and law enforcement puts a lot of faith & creditability in the reliability of this poorly design system. As well as the QOL of pts that is having this applied to their medical care with seemingly no follow up as to how the guidelines are applied and/or pt’s outcomes are affected.

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Alcohol death rate in US is rising, government reports say

Posted on November 4, 2022 by Pharmaciststeve

Alcohol death rate in US is rising, government reports say

https://www.foxnews.com/health/alcohol-death-rates-us-rising-government

A CDC report found the rate of related deaths rose by 26% in the first year of the pandemic

Deaths that can be directly attributed to alcohol rose nearly 30% in the U.S. during the first year of the COVID-19 pandemic.

Two new reports from the Centers for Disease Control and Prevention showed which states are seeing the highest numbers and which groups are impacted. The agency already said such deaths rose in 2020 and 2021.

According to the World Health Organization, the harmful use of alcohol is a causal factor in more than 200 disease and injury conditions, with 3 million resulting deaths annually.

AFTER FENTANYL KILLED HER SOULMATE, RECOVERING DRUG USER FIGHTS TO END STIGMA OF ADDICTION

Bottles of Jim Beam brand bourbon whiskey for sale at the James B. Beam distillery in Clermont, Kentucky, US, on Tuesday, July 26, 2022.  (Photographer: Luke Sharrett/Bloomberg via Getty Images)

The rate of those deaths had been increasing by 7% or less each year, but rose 26% in 2020 – the highest rate in at least 40 years.

There were more than 52,000 such deaths last year. That number rose from 39,000 in 2019, for both men and women. The deaths are 2.5 times more common in men.

In this Nov. 30, 2017 photo, a patron sips his drink while having a meal at a bar in New Jersey. ((AP Photo/Julio Cortez, File))

CHILD DEATHS FROM ACUTE KIDNEY INJURY RISES TO 133 IN INDONESIA

The rate also remained higher for people ages 55 to 64, but also jumped 42% among women ages 35 to 44.

A second report looked at a wider range of deaths that could be linked to alcohol, including cancers and motor vehicle accidents.

Corona Extra beer arranged in the Brooklyn Borough of New York, U.S., on Tuesday, Nov. 23, 2021.  (Photographer: Gabby Jones/Bloomberg via Getty Images)

Researchers said more than 140,000 of that broader category of deaths occur annually, based on data from 2015 to 2019. That is more than 380 deaths each day.

About 82,000 are from drinking too much over a long period of time and 58,000 are from causes tied to acute intoxication.

CLICK HERE TO GET THE FOX NEWS APP

The study found that as many as 1 in 8 deaths among U.S. adults ages 20 to 64 were alcohol-related deaths.

New Mexico had the highest percentage of alcohol-related deaths, at 22%.

Mississippi had the lowest.

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The CDC Replaces Flawed 2016 Opioid Prescribing Guideline with a Flawed 2022 Opioid Prescribing Guideline

Posted on November 4, 2022 by Pharmaciststeve

I think that I posted when they announced that they were going to renew the 2016 guidelines, that over my 5+ decades of watching bureaucrats… when an existing rule/law/regulation gets re-opened to improve it… it seldom makes things better….  more often than not… things get worse.  With this version of the opiate dosing guide, there is only five “experts”  with at least one returning from the original committee… there is some 20 pages of footnotes and references and one ENTIRE PAGE – containing abt 12 references with the first name listed as a author on all these references is one of the five “experts” on this edition of the guidelines.

Since the publishing of the 2016 guidelines, a physician published a article – which basically created the genealogy of the MME system – which showed that the conclusions of the MME system have no science behind them nor double blind clinical trials.   Yet these five “experts” referenced the same MME system as to determine “recommended” daily opiate limits. Since pain management is dealing with a subjective disease. There are no definitive tests to determine if the pt is in pain nor the intensity of their pain and the typical chronic pain pt… their intensity of pain will vary – sometimes dramatically – day to day and/or within a single 24 hr period.

In June, 2022 a SCOTUS ruling (9-0 vote) https://www.pharmaciststeve.com/supreme-court-tells-cops-to-stop-playing-doctor-but-will-they-listen-or-back-to-business-as-usual/  basically told the DEA that they cannot use objective criteria when judging a prescriber in how they treat/dose opiates for pts dealing with subjective diseases – like pain.  Here we are a few months later with the CDC coming out with objective criteria … suggesting how prescribers should dose opiates in treating chronic pain.  If SCOTUS tells the DEA not to use objective criteria to decide if a prescriber is properly treating a chronic pain pt.  Then how can it be legal for FIVE “experts” to create objective criteria in how prescribers should treat chronic pain pts.  Isn’t that  why a person gets a medical degree and passes the state’s medical licensing boards…  to practice medicine and treat pts.  The practice of medicine can be broken down into two primary functions – diagnosing the medical issue(s) that the pt is dealing with and starting, changing, stopping a pt’s therapy.

Isn’t the CDC attempting to supersede  the FDA dosing guidelines and interfere with the professional discretion granted to the prescriber by the state licensing board ?


The CDC Replaces Flawed 2016 Opioid Prescribing Guideline with a Flawed 2022 Opioid Prescribing Guideline

https://www.cato.org/blog/cdc-replaces-flawed-2016-opioid-prescribing-guideline-flawed-2022-opioid-prescribing-guideline

Responding to medical experts, including the American Medical Association, who have been complaining for years that the Center for Disease Control and Prevention’s 2016 Guideline for Prescribing Opioids for Chronic Pain lacked a strong basis in the evidence—and after it issued an Advisory in 2019 stating the Guideline was misinterpreted and “misapplied” by state lawmakers and health care practitioners—the CDC announced it was going to revise the Guideline before the end of 2022. Unfortunately, 38 states have already cast the flawed 2016 Guideline in stone by enshrining—and misapplying—all or part of it in statutes that dictate how health care practitioners may treat patients in pain.

In February of this year, the CDC released a draft of the revised Guideline and requested comments. I provided my comments here. In those comments, I stated. “Notwithstanding the well‐​intentioned exhortations and disclaimer in the draft 2022 opioid prescribing guideline, the recommendations change very little from those put forth in 2016.”

The CDC goes to great lengths to stress throughout the draft 2022 Guideline that the document is meant to serve as a list of suggestions and recommendations and is by no means intended as a mandate, emphasizing that physicians should use their best clinical judgment to provide individualized treatment to their patients. However, I commented, “The CDC guideline will inevitably become interpreted and adopted as hard and fast rules by state and local governments, pharmacies, health plans, and third‐​party payers, despite guideline warnings against doing so.”

I also criticized the draft for suggesting dosages based on “morphine milligram equivalents” of opioids:

For example, the guidelines still rely on Morphine Milligram Equivalent (MME) dose recommendations, even though there is no pharmacologic or biochemical basis for relying on equianalgesic conversion factors.

The use of MME conversion tables is nothing more than junk science. As Dr. Nabarun Dasgupta of the University of North Carolina Injury Prevention Center has written:

Contrary to conventional wisdom, conversion values are not based on pharmacologic properties. Instead, they arose 60 years ago from small single‐​dose clinical studies in postoperative or cancer populations with pain score outcomes; toxicologic effects (e.g., respiratory depression) were not evaluated.

On November 3, the CDC published the final version of the 2022 Clinical Practice Guideline for Prescribing Opioids for Pain. The Guideline no longer recommends MME dosage thresholds, but it still urges practitioners to be cautious about prescribing more than 50 morphine milligram equivalents of opioids per day, stating :

Many patients do not experience benefit in pain or function from increasing opioid dosages to ≥50 MME/​day but are exposed to progressive increases in risk as dosage increases. Therefore, before increasing total opioid dosage to ≥50 MME/​day, clinicians should pause and carefully reassess evidence of individual benefits and risks. If a decision is made to increase dosage, clinicians should use caution and increase dosage by the smallest practical amount.

To prevent the recommendation from being “misapplied,” the Guideline adds the following disclaimer to the above paragraph:

The recommendations related to opioid dosages are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician‐​patient decision‐​making.

Alas, the 2022 Guideline still includes the now‐​discredited MME conversion table that providers can refer to when prescribing opioids.

The Guideline recommendations are still primarily based on “Type 3” and “Type 4” evidence, evidence with important limitations.

If the past is prologue, expect the Guideline’s suggestion to use caution approaching a dose of 50 MME to morph into another de facto mandate as lawmakers, pharmacies, and insurance plans fixate on that number. As Josh Bloom and I have written before:

When a government agency “recommends” a policy, it’s akin to a recommendation from Tony Soprano; it is inevitably interpreted as a mandate, obeyed by state and federal agencies, health insurers, and even pharmacies.

Perhaps most egregiously, the rationale of the 2022 Guideline remains predicated on the flawed assumption that overprescribing opioids caused the overdose crisis. There is no correlation between prescription volume and the nonmedical use or addiction to prescription opioids. And the percentage of people aged 18 or older addicted to prescription pain pills has been unchanged at less than one percent this entire century. The CDC should follow the evidence and abandon this mistaken premise.

Finally, as I concluded in my comments on the draft proposal back in February 2022:

1‑The Centers for Disease Control and Prevention should not be issuing opioid prescribing guidelines. Professional specialty organizations, overseen by practicing clinicians and clinical educators, are the institutions that should be issuing standard of care and best practices guidelines.

2‑The CDC guideline will inevitably become interpreted and adopted as hard and fast rules by state and local governments, pharmacies, health plans, and third‐​party payers, despite guideline warnings against doing so.

3‑The 2022 guideline very closely resembles the 2016 guideline and is based on weak evidence; in the case of Morphine Milligram Equivalent recommendations, the guideline is pharmacologically unsound, and the conversion tables are based largely on decades‐​old subjective studies that didn’t even examine toxicologic effects such as respiratory depression rates.

4‑The overdose crisis is largely caused by a growing population of nonmedical drug users intersecting with increasingly dangerous drugs being developed for the black market fueled by drug prohibition. Efforts to address the problem through reductions in opioid prescribing have only exacerbated the situation by driving nonmedical users to more dangerous drugs while depriving pain patients of necessary relief.

5‑The Centers for Disease Control and Prevention should abandon its efforts to establish a prescribing guideline and defer to the professional institutions usually charged with establishing best practices.

Nothing in the just‐​published Guideline makes me want to reconsider that conclusion.

Filed under: General Problems | 4 Comments »

CVS Health is standing up to protect their own profits – using a “smoke screen” and accusing others of profiteering

Posted on November 4, 2022 by Pharmaciststeve

CVS Health is standing up for Louisianans

https://www.cvshealth.com/news-and-insights/articles/cvs-health-is-standing-up-for-louisianans

“By inserting themselves in the state’s process of selecting a firm to manage prescription drug coverage for the Office of Group Benefits, special interest groups representing Louisiana’s independent pharmacists attempted to line their own pockets at the expense of the state’s taxpayers, employees and retirees.

“Following a fair and competitive procurement process, CVS Health stood ready to provide a prescription drug benefit plan for state employees that the state’s independent analysis estimated would save more than $100 million in the first year, while also including a fair and market-based rate for reimbursing independent pharmacists. Instead, those same pharmacists opted to put profits over patients – inserting themselves into a process where the state had already outlined providing them fair compensation.

“This situation has set a dangerous precedent, endangering the healthcare coverage of state employees, threatening the fiscal solvency of the state employee and retiree benefit plan, and emboldening special interest groups whose sole concern is lining their own pockets. This bullying behavior, at a time when the state is facing unparalleled economic uncertainty from a global pandemic and countless natural disasters, is nothing short of shameful. Moreover, it represents an alarming trend that all states should be concerned about.

“While we are disappointed in the outcome, we remain fully committed to working with public and private clients across Louisiana to deliver pharmacy coverage that puts patients first and brings down the costs for prescription drugs. Sadly, the independent pharmacists cannot say the same.”

Several years ago, the Treasurer of Arkansas and the Arkansas Pharmacist Association did a price survey on the cost of the state employee medication costs. The program was managed by Caremark – which is owned by CVS Health.  The survey involved 250-260 different medications and the prices that were being paid by Caremark to the various local pharmacies where state employees got their medications filled.

ON AVERAGE, a medication filled at a CVS community pharmacy got paid by Caremark abt 60.00 MORE than what was paid to other pharmacies in the state that were competitors of CVS health drug stores for filling the same medication, strength and quantity.

Does this suggest that CVS Health is well versed in how a corporation can “line their own pockets at the expense of the state’s taxpayers, employees and retirees”

There is THREE PBM’S that control abt 75% of the Rx market place, both in what medications are covered and what they pharmacies get paid for filling such medications.  If you include the TOP 5 PMB’S you are talking about controlling abt 90% of the market.

If anyone questions the “bad financial behavior ” of the PBM industry just do a web search using the phrase “prescription benefit managers law suits”.

Over the last 5 yrs, the top 5 PBM companies are now owned by companies that are in the insurance business.  Before this, PBM’s and insurance companies were suing each other over claimed over charging or under payments.

Filed under: General Problems | 1 Comment »

The “BAD AND THE UGLY – there is NO GOOD” of the PDMP’s and Narxcare and the INACCURATE CONCLUSIONS from those databases

Posted on November 3, 2022 by Pharmaciststeve


This is a video about ONE HOUR LONG… normally, I don’t sit thru such a long video.  This is a VERY INTERESTING presentation put on by Dr. Jennifer Alva – an attorney with a very broad legal background. She talks about how the various state PDMP who has apparently turned their data collecting responsibility over to  Experian   who now owns Bamboo Health 

who owns/operates  Narxcare  that produces a SUBSTANCE ABUSE SCORE.. on pts prescribed controlled substances.

You just have to listen to Dr Alva’s explanation of how faulty data is collected and assigned to pts and prescribers and how the DOJ/DEA is accepting the conclusions from data mining these faulty data points and use it to go after prescribers to prove that the prescribers are illegally prescribing controlled substance

 

https://stanford.zoom.us/rec/share/F6IC_Sitiu4lmGQgBbD9wVvOb5iG9Eal7fnJrqC2G2lMMEjDM8H4mv4D_hOjD6mY.jqBbyLkUm9RvzhKS

Here is a up coming seminar concerning the MME system

Guest Speaker Series

Wednesday, November 16, 2022

Dr. Nabarun Dasgupta

Nabarun Dasgupta, MPH, PhD

Dr. Nabarun Dasgupta is a scientist at the Opioid Data Lab (OpioidData.org) at the University of North Carolina with 2 decades of experience in opioid epidemiology and overdose prevention. His passion is telling true stories about health, with numbers. Centered in epidemiology, his multidisciplinary approach draws on large database analytics, qualitative field studies, laboratory investigations, randomized trials, and community-based interventions. Through his work he aims to amplify community and patient voices in public health. He works closely with patients with pain conditions and believes they can be equal partners in scientific research. His lab at UNC tests street drugs (https://streetsafe.supply) from around the country to understand the implications of illicit drug supply fluctuations on health. He also tracks street prices for prescription medications (StreetRx.com). He is the co-founder of Remedy Alliance For The People, a ground breaking national naloxone bulk distribution non-profit supplying millions of doses of the opioid reversal antidote to harm reduction programs (RemedyAllianceFTP.org). Follow him on Twitter @nabarund

FREE VIRTUAL CME LECTURE | November 16, 2022

Inches, Centimeters, and Yards: How MME Hidden Variations in MME Calculations Influence Opioid Safety

Zoom Webinar | 11:00am – 12:00pm PST |  REGISTER NOW

ACCREDITATION

In support of improving patient care, Stanford Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

CREDIT DESIGNATION

American Medical Association (AMA)
Stanford Medicine designates this Live Activity for a maximum of 1.0 AMA PRA Category 1 CreditsTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Council of Pharmacy Education (ACPE)
Stanford Medicine designates this knowledge-based activity for a maximum of 1 hour. Credit will be provided to NABP CPE Monitor within 60 days after the activity completion.

Universal Activity Number List: UAN: JA0000751-0000-22-017-L08-P

American Nurses Credentialing Center (ANCC)
Stanford Medicine designates this live activity for a maximum of 1.0 ANCC contact hour.

ASWB Approved Continuing Education Credit (ACE)
As a Jointly Accredited Organization, Stanford Medicine is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit. Stanford Medicine maintains responsibility for this course. Social workers completing this activity receive 1.0 general continuing education credits.

American Psychological Association (APA)
Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibly for the content of the programs.

American Academy of PAs (AAPA)
Stanford Medicine has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This live activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.

Physical/Occupational Therapy
Stanford Health Care Department of Rehabilitation is an approved provider for physical therapy and occupational therapy for courses that meet the requirements set forth by the respective California Boards. This course is approved for 1.0 hour CEU for PT and OT.

 

Filed under: General Problems | 3 Comments »

CDC Just Changed Its Opioid Prescribing Guidelines. Here’s What to Know

Posted on November 3, 2022 by Pharmaciststeve

CDC Just Changed Its Opioid Prescribing Guidelines. Here’s What to Know

https://www.medpagetoday.com/neurology/opioids/101559

Guidance covers acute, subacute, and chronic pain and replaces 2016 guidelines

Hard thresholds for pain medication doses and duration are no longer promoted through the CDC’s new Clinical Practice Guideline for Prescribing Opioids for Pain.

The new guidance — which covers acute, subacute, and chronic pain for primary care and other clinicians — updates and replaces the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as imposing strict opioid dose and duration limits and was misapplied by some organizations, leading the guideline authors to clarify their recommendations in 2019.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a CDC press briefing. They should not be used as an inflexible, one-size-fits-all policy or law, or applied as a rigid standard of care, or replace clinical judgement about personalized treatment, he emphasized.

“Patients with pain should receive compassionate, safe, and effective pain care,” Jones stated. “We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life.”

The guidance, published in Morbidity and Mortality Weekly Report, addresses four key areas: initiating opioids for pain, selecting opioids and dosages, deciding prescription duration and conducting follow-up, and assessing risk and potential harms of opioids. It suggests that clinicians work with patients to incorporate plans to mitigate risks, including offering naloxone.

The 100-page document indicates opioids should not be considered as first-line or routine therapy for subacute or chronic pain, and points out that non-opioid therapies often are better for many types of acute pain.

“For patients receiving opioids for 1 to 3 months (the timeframe for subacute pain), the 2022 guideline recommends that clinicians avoid continuing opioid treatment without carefully reassessing treatment goals, benefits, and risks in order to prevent unintentional initiation of long-term opioid therapy,” wrote Debbie Dowell, MD, MPH, chief clinical research officer for CDC’s Division of Overdose Prevention, and guideline co-authors in a commentary published in the New England Journal of Medicine.

For chronic pain, clinicians should maximize use of non-opioid therapies and consider initiating opioid therapy only if the expected benefits for pain and function are anticipated to outweigh the risks, Dowell and colleagues noted. When opioids are needed for chronic pain, clinicians should start at the lowest effective dose, evaluate benefits and risks before increasing dosage, and avoid raising dosage above levels likely to yield diminishing returns, they added.

“These principles do not imply that nonpharmacologic and non-opioid pharmacologic therapies must all be tried unsuccessfully in every patient before opioid therapy is offered,” Dowell and colleagues wrote. “Rather, expected benefits specific to the clinical context should be weighed against risks before therapy is initiated.”

The new guideline offers tips for tapering opioids when warranted, but is not intended to lead to rapid opioid tapering or discontinuation, Jones noted. The recommendations do not apply to sickle cell disease-related pain, cancer pain, and palliative or end-of-life care.

The 2022 document incorporated feedback from approximately 5,500 public comments since the new version was first proposed in February, including reactions from people who discussed their experiences with pain or opioid addiction and barriers to pain care. An independent federal advisory committee, four peer reviewers, and members of the public reviewed the draft version.

“The science on pain care has advanced over the past 6 years. During this time, CDC has also learned more from people living with pain, their caregivers, and their clinicians,” Dowell said in a statement. “We’ve been able to improve and expand our recommendations by incorporating new data with a better understanding of people’s lived experiences and the challenges they face when managing pain and pain care.”

The clinical practice guideline supports the HHS Overdose Prevention Strategy, the CDC said. The agency also is providing additional information associated with the guideline to clinicians and patients.

Filed under: General Problems | 5 Comments »

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