I wonder if this letter represents the mindset of many of those in the Senate.  — These new rules/guidelines do not prevent any physician from prescribing pain medications outside the normal prescribed dose as long as the physician can support the decision to do so, through documentation.

Just who defines “normal prescribed dose”– the FDA— the CDC — the DEA ? What I have mostly read from articles on prescriber being taken  to federal court that the prescriber exceeded standard of care and best practices… Are they referencing the FDA dosing guidelines in the professional dosing information or are the following the CDC MME system recommendations – which has no science nor double blind clinical studies supporting their conclusion ?

The typical chronic painer is not waiting for a federal/state agency to compel the prescriber to prescribe them opiates.  At least Senator Johnson understands that the DEA has intimated may prescribers to stop prescribing or dramatically lower the pt’s dose.

Senator Johnson wrote this in Jan, 2023 – The federal agencies are not likely to make any changes to these policies or guidelines – that is SIX MONTHS after the SCOTUS ruled (9-0 vote ) in the Ruan/Kahn that the DEA could not use OBJECTIVE CRITERIA in judging prescriber treating pts dealing with SUBJECTIVE DISEASES.  Does Senator Johnson and other members of Congress knows something about the DEA future plans in dealing with prescribers that is not being shared with others ?

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There is a term in pharmacology – LD50 – it is the dose that 50% of the animal/human taking such a dose – 50% would die !
https://go.drugbank.com/drugs/DB00813

Fentanyl has an intravenous LD₅₀ of 2.91mg/kg in rats¹, an oral LD₅₀ of 18mg/kg in rats and 368mg/kg in mice.^MSDS The LD50 in humans is not known.

This is all I could find regarding LD50 for Fentanyl, but according to Wikipedia there is some 400 known different analogs of fentanyl… and the FDA approved analog – citrate – is claimed to be about twice the potency of the analog (acetate) that is typically used in illegal fentanyl tabs from the Mexican cartels.

“back in the day” we kids had “connect the dots” graphic that would display some sort of image when all the dots were connected. Over the last few weeks, I have seen where numerous federal entities or members of Congress are publicly sharing “dots” of information about the war on drugs. Such things as the attached video where the “expert” testifying on a trial, showing the cartels and the routes of distributions used by the various cartels and that the DEA has been fully aware of all of this for maybe TWO DECADES.

Recently on a national new program it was stated that 379 MILLION illegal fentanyl tabs were confiscated in the USA in the last calendar year and/or last federal fiscal year and just this week a member of Congress from Arizona on national TV program and the millions of illegal fentanyl tablets that are being released to the media only represents 8% to 15% of what actually comes across the border.

So this would mean that anywhere from  2.52 BILLION to   4.7 BILLION is coming across our boarders every year.  This means that 2.15 BILLION to 4.32 BILLION illegal fentanyl tablets actually gets to our streets.

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This is a basic ROAD MAP of the major players in our healthcare system and who “owns” who and who “controls ” who

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I am not sure what this means, it is around the change of practitioners treating pts who are addicted or diagnosed with Opiate Use Disorder. What interpretations that the DEA generates in the future – one can only guess –

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WARNING LETTER

Optum Infusion Services 308 LLC

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/optum-infusion-services-308-llc-647842-12132022

WARNING LETTER

December 13, 2022

Dear Dr. Kottmer:

From March 8, 2022, to March 18, 2022, a U.S. Food and Drug Administration investigator inspected your facility, Optum Infusion Services 308 LLC, located at
2555 West Fairview Street Suite 104 Building D, Chandler, Arizona 85224. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 to your firm on March 18, 2022. FDA acknowledges receipt of your facility’s response, dated April 8, 2022. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Compounded Drug Products Under the FDCA

Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:

1. You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area. Vermin are a source of microbial contamination. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.

2. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

3. An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.

It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

C. Corrective Actions

We have reviewed your firm’s responses to the Form FDA 483. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:

1. In response to Observation 5 of the Form FDA 483, you stated that you changed pest control providers, installed insect light traps, and that you will be installing air curtains on exterior doors and plastic flap curtains inside of the warehouse door. It is unclear where the insect light traps, air curtains, or vortex curtains will be installed in relation to the classified areas. Additionally, it is unclear when these corrective actions will be fully implemented.

2. Regarding your response to Observation 1 of the FDA 483, we acknowledge your response indicating that you will update the way you assess and document the risk associated with every “patient compound” potentially affected by an excursion and train staff on the new policy. Also, you stated that you have conducted a retrospective review of “compounds” referenced in the observation and found there to be no product or patient impact. However, your response lacked supporting evidence, for example, you did not provide the retrospective review referenced. Furthermore, we acknowledge your response states, in SOP Compounded Sterile Product Impact Assessment Process, that a low risk level would be determined by the pharmacist in charge (PIC) based on the actionable microbial growth. Please note, any microbial contamination in the ISO 5 area is considered an insanitary condition.

Additionally, your response states, in SOP Compounded Sterile Product Impact Assessment Process, that “(b)(4).” Please note, any microbial contamination within the ISO 5 area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.

3. In response to Observation 2 of the Form FDA 483, you stated that you provided on-site training to staff. However, you did not provide the attachment Aseptic Technique Evaluation Update 04072022 referenced in your response.

Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.

D. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time in which you will do so.

Send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506

Please identify your response with unique identifier 647842.

If you have any further questions, please contact Nayan Patel, compliance officer, by email at Nayan.Patel1@fda.hhs.gov or by phone at (303) 236-3010.

Sincerely,
/S/
Steven E. Porter, Jr.
Program Division Director
Division of Pharmaceutical Quality Operations IV

CC: Keith McFalls, Regional Vice President (via e-mail k.mcfalls@optum.com)
3428 Wild Oaks Court
Burleson, TX 76028
(817) 676-8760

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Singer Is Paralyzed After Delay in Care; Hospital Must Pay

https://www.medscape.com/viewarticle/986937

Delay in Treatment Will Cost Hospital Millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Texas, prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Jessie remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department (ED), staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself it wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Adams continued to experience excruciating pain. “I kept screaming, ‘Help me,’ ” she recalls today. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Adams and her husband $10.1 million, including $500,000 for Richard Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Richard spends most of his time taking care of Jessie.

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$189 charged, $15 collected: The life and death of a local independent drugstore

https://vtdigger.org/2023/01/16/189-charged-15-collected-the-life-and-death-of-a-local-independent-drugstore/

BRATTLEBORO — Eye all the photos, postcards and news clippings that paper Mary Giamartino’s office, and you’ll see how the Hotel Pharmacy opened at downtown’s Brooks House in 1940, then kept its name when it moved to the old fire station in 1978 and to the former Methodist church in 1993.

But just past the store shelves lit by century-and-a-half-old stained-glass windows is a stack of bills that illuminates an even bigger contrast.

Take the prescription for the pain reliever hydromorphone. The pharmacy bought it for a patient at $189.12. Yet, after the customer’s $10 copay, insurance reimbursed only another $15.21.

“I lost $163.91,” Giamartino said. “But do you not fill it? No, this woman was dying.”

And so, as a result, is the local independent drugstore — a shooting star outside a larger galaxy of corporate insurers, big-box pharmacies and generic manufacturers.

“Loss, loss, loss, loss, loss, loss, loss …” Giamartino said as she ran her finger down record after record calculating what’s charged versus what’s collected. “It just kept getting worse and worse and worse and worse and worse and worse. Like beyond worse.”

That’s why the Brattleboro mom-and-pop will close for good Tuesday after 83 years, dispersing customers to one of the town’s four chain drugstores while dropping the number of Vermont independents from upward of 50 a decade ago to 16 today.

“Insurance company reimbursements to us are so low, we can’t make any money,” Giamartino said. “It just got to the point where there was nothing else I could do.”

The 67-year-old didn’t envision her current predicament when she and her fellow pharmacist husband, Frank, bought the business in 1982. Working more collaboratively than competitively, the drugstore was one of three downtown seemingly founded by Mr. Gower in the film “It’s a Wonderful Life.”

Moving to the former Methodist church, the metropolitan New York family hung Mets baseball banners under the vaulted ceiling, rock-riffing stereo speakers where the choir once sang, and snapshots everywhere else of sons Vincent and Nicholas — the latter pictured on a school bus alongside classmate (and current state treasurer) Mike Pieciak.

Then came tragedy. In 2001, Nicholas died in his sleep from an infection at age 17. Five years later, in 2006, Frank was killed in a car crash at age 53.

“The only good thing about this,” the wife and mother told the local paper upon her husband’s death, “is that every day he won’t have to wake up and say, ‘I love you, Nick. I miss you.’”

Giamartino has run the business ever since, heading a team of 20 employees who offer 24-hour emergency service, local delivery and the ability to compound medication in-house.

“They go out of their way to support the clientele,” said Karen Peterson, outgoing executive director of the AIDS Project of Southern Vermont. “It doesn’t matter who you are or what your status is in the community. You feel cared for there. You are an individual, not a number.”

Hotel Pharmacy has stood alone after the closure of Brattleboro’s three other mom-and-pop drugstores. Statewide, it has seen counterparts recently shuttered or sold to larger outfits in Bennington and Manchester; Bristol, Middlebury and Vergennes; Rutland; and Woodstock.

Independent drugstores hope a new Vermont law boosting state regulation of pharmacy benefit management will start to stem the losses.

“Pharmacies are not in control of their financials — we don’t control the cost of the medications, nor do we control the reimbursement,” said Jeff Hochberg, president of the Vermont Retail Druggists Association. “Every state in the country is feeling this, rural ones in particular. I think that pharmacy is a great bellwether for true reform of the health care system.”

The Vermont Department of Financial Regulation is set to release a report on the issue this month. But it’s too little too late for Hotel Pharmacy, which has waded too many years in red ink.

Giamartino tried to cut costs by dropping advertising, then donations to community causes, then staff raises and bonuses. This past year she looked for someone to buy the business.

No one made an offer.

“A friend said, ‘Mary, it’s going to break your heart. Get ready.’ And I said, ‘I bet everything I have that it won’t.’ I was wrong.”

And so Giamartino reached out to Brattleboro’s two chains, Rite Aid and Walgreens, before deciding to pass on her customer files to the latter upon the close of business Tuesday.

No one is happy with the ending, as seen on social media or heard through talk about town.

“We made sure our patients would be OK,” said Jodi Harrison, a pharmacy technician for three decades. “Now we’re not sure who’s going to make sure.”

Giamartino is set to sell the building, but not before gathering the photos, postcards and clippings that hold so many memories.

“I am going to remember working with a wonderful group of people that gave the best possible pharmacy care that anybody could,” she said. “There’s nothing like helping somebody, making them feel better, letting them die the way they want to die.”

Even if, as she understands firsthand, they ultimately don’t want to.

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VA to pay for all emergency mental health care starting Jan 17, 2023

https://www.legion.org/veteranshealthcare/257959/va-pay-all-emergency-mental-health-care-starting-next-week

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An Update on RCTs for Knee Osteoarthrtitis

https://regenexx.com/blog/an-update-on-rcts-for-knee-osteoarthrtitis/

Two years ago, I summarized all of the RCTs for PRP used to treat knee arthritis. It’s now time for an update, especially with the recent craziness around fake PRP studies. Let’s dig in.

What Is an RCT?

The top level of research quality is called an RCT or Randomized Controlled Trial. Usually, two treatments are compared and the study participants are randomly assigned to one group or the other. The type of patients admitted and how they’re treated is rigorously controlled.

My 2020 Infographic

Shortly after Google bowed to pressure from academics who didn’t like the fact that PRP was competing with their licensed technologies winding their way through the FDA gauntlet, I put together an infographic that summarized all of the research on PRP used to treat knee arthritis (OA or osteoarthritis). It found more than two dozen studies that compared PRP to various controls like saline or hyaluronic acid. All of these showed that PRP helped knee OA:

If you click on the image above, you get taken to a PDF and each circle is a link out to a study. The studies are listed by their category, for example, “Vs HA” means that the study compared the efficacy of PRP versus HA for the treatment of knee OA.

The Fake PRP Study Issue

I’ve blogged already on new studies that purported to use PRP but really used something much less concentrated (i.e. Bennell et al) that didn’t meet the definition. These fake PRP studies showed that what they used didn’t work. However, even if a footnote is needed, those studies have to be added into the total body of PRP literature, hence it was time for an update.

Join us for a free Regenexx webinar.

My 2022 Infographic

Here’s my latest PDF summarizing everything I found in the US National Library of Medicine as of yesterday:

There are now 39 RCTs (there were 32 in 2020) with 37 showing that PRP is effective in the treatment of knee OA (blue circles) and 2 showing that it didn’t work (red circles). One of those is a small study comparing PRP to plasma and saline. The other is the Bennell et al study I have already reviewed on the blog.

Here is the total number of patients (n) represented above that were part of studies where PRP worked (Pro) versus PRP was ineffective (Con):

If we just include larger studies of 150 patients or more in the same league as Bennell et al, this is that comparison:

If we increase that to 200 patients, then it’s 4 to 1.

The upshot? PRP RCTs continue to show overwhelming evidence that the treatment is safe and effective for the treatment of knee osteoarthritis. There’s so much published to date that’s it’s hard to draw any other conclusion. However, even if the Bennell et al study didn’t use PRP, given that it claimed to, it needs to be included in the body of literature, even if it needs a major footnote.

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