If you ever have blood pressure that’s 180/120 or above, it’s an EMERGENCY

According to this article How Do I Know if I Need High Blood Pressure Drugs?  If you ever have blood pressure that’s 180/120 or above, it’s an EMERGENCY You need medical help right away to get it under control.

did everyone know that Medicare checks pts taking meds for diabetes,high blood pressure, and high cholesterol checks to see if they are taking their meds as prescribed… medically being compliant. Supposedly, they are suppose to “financially ding” prescribers and pharmacists/pharmacies if their pts are NOT routinely compliant.  Apparently there is no verification that the medication that the pt is being prescribed and routinely taking is not getting their blood pressure to an acceptable levels – typically <135/85.

How many chronic pain pts has their blood pressure increase as the prescriber has been reducing their pain meds.  You are put on up to 5 different blood pressure meds and your pressure remains at/near same HIGH LEVELS. They refuse to see any relationship with your reduced pain meds and your elevated BP and all the BP meds being prescribed … are DOING NOTHING !

They claim that there are no tests to evaluate that a pt is dealing with chronic pain and the intensity of their pain.  It is becoming quite obvious that many chronic pain pts who have their med therapies reduced and their blood pressure has increased and the prescriber adds 4-5 different categories of pharma anti-hypertensive meds and the pt’s elevated BP does go down.

Shouldn’t prescribers give pts a 30 day trial of a opiate to see if opiate therapy would lower their blood pressure ? I would suggest giving a pt Norco-10 and let the pt to be able to determine what dose they need to lower their overall pain. Norco-10 every 3 hrs around the clock as needed.  This dose is both under the 2016 CDC guideline of max of 90 MME/day and under the max recommended dose of Acetaminophen/Tylenol/day.  I would suggest that the pt take their blood pressure when they get up in the AM, after lunch, after supper and at bedtime and the pt – ideally – the pt should create a chart using a spread sheet over the 30 days, and the pt should wean themselves down over the last week of available meds.

What if the pt’s BP goes down some, but no where near the ideal BP of  < 135/85 ?  That would strongly suggest that the pt may still be dealing with under treated pain, but that their body – because of still high BP… is still dealing with elevated BP that higher dosing or using a different opiate may help lower the pt’s BP even lower.   This is may also be a good time for the pt to do DNA pharmacogenomic testing that would point out if the pt is a fast/ultra fast metabolizer for Hydrocodone and/or would better metabolizer of a different opiate.

The long term adverse health affects to pts with under/untreated pain can be quite dramatic.  High blood pressure has always been labeled as the SILENT KILLER. Attached graphic illustrates most all of those “bad outcomes” of under/untreated high blood pressure.

Medical Board Takes Action Against Misinformation Doc

— Pathologist Ryan Cole, MD, is facing discipline for negligence, spreading false statements

https://www.medpagetoday.com/special-reports/features/10270

An Idaho pathologist who previously came under fireopens in a new tab or window for prescribing ivermectin to COVID-19 patients and spreading falsities about vaccines, is facing disciplinary actionopens in a new tab or window by the Medical Commission in Washington state, where he is also licensed to practice.

Ryan Cole, MD, is said to have made “numerous false and misleading statements” during public presentations on the pandemic, COVID vaccines, the use of ivermectin to treat COVID, and the effectiveness of masks, according to a statement of chargesopens in a new tab or window issued by the Washington Medical Commission earlier this month. He also allegedly provided negligent care to a number of patients in the prevention or treatment of COVID.

“Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust,” the commission wrote in the statement. “That public trust is essential to effective delivery of medical care. Knowingly false statements or those made in reckless disregard for the truth, such as the medical disinformation statements by respondent … erode the public’s trust in physicians and their medical treatment and advice, and thereby injure public health.”

Specifically, at all times relevant to the case, Cole, an anatomical and clinical pathologist, ran an independent medical laboratory that he owns, provided direct care to patients via telemedicine through the website MyFreeDoctor.com, and spoke at public and private forums, as well as on news shows and podcasts, the statement noted.

According to the commission, since March 2021, Cole is said to have made false and misleading comments during his presentations, including, “Children survive [COVID-19] at a hundred percent,” and “A hundred percent of world [ivermectin] trials have shown benefit.”

Other public statements Cole is said to have made include that the COVID vaccine is “an experimental biological gene therapy immune-modulatory injection,” in addition to “a fake vaccine … the clot shot, needle rape.”

In a written statement to the Washington Medical Commission dated Feb. 7, 2022, Cole wrote that he had not advised patients or the general public to not get the COVID vaccine, contrary to other remarks included in the statement of charges.

As for the allegations of negligent patient care, the statement included descriptions of telemedicine provided in June and July 2021 to four unnamed patients.

“For all of these patients, respondent prescribed medications that are not indicated for a COVID-19 infection, failed to properly document adequate justification for the treatment in the medical record, failed to take a history or perform a physical examination, and failed to obtain appropriate informed consent,” the commission wrote. “Respondent also provided inadequate opportunity for follow-up care, treated patients beyond his competency level, and did not advise patients about standard treatment guidelines and preventative measures.”

The Idaho Capital Sun reported that Cole has until the end of the monthopens in a new tab or window to respond to the statement of charges, and that the physician has previously maintained that he did not violate standardsopens in a new tab or window while treating patients for COVID via telemedicine.

The news outlet further noted that Cole serves as the CEO of his laboratory, Cole Diagnostics, located in Garden City, Idaho, and is currently licensed by the Idaho Board of Medicine, as well as medical boards in several other states.

A search of the Idaho Board of Medicine’s online portal showed no action against his license there.

Cole did not immediately return a request for comment.

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Utah man arrested for murder after telling police he killed his wife at her own request

https://www.fox13now.com/news/local-news/utah-man-arrested-after-telling-police-he-killed-his-wife-at-her-own-request

ROY, Utah — A man was arrested Saturday for allegedly shooting and killing his wife in Roy, claiming she asked him to do so because she was in extreme pain.

He also told police that he killed her earlier in the week but waited about four days to report it.

Dave Meyer, age 69, was booked on suspicion of murder for his wife’s death, as well as other charges in connection to the incident.

Police responded to Meyer’s home on Saturday after emergency dispatch indicated that he killed his wife. Officers took him into custody without incident, then while sweeping the home, they found a woman who was dead. The victim was confirmed as his wife, 62-year-old Suzanne Meyer.

Meyer agreed to speak with police after being informed of his Miranda rights, according to the arrest report. He said his wife had been in pain for 11 years because of a car accident, and he had watched her suffer from back pain and nerve damage for many years. He claimed that she had been “asking him to kill her for a while now due to the amount of pain she has been in.”

Meyer explained to investigators that he was rubbing his wife’s back one day when he saw his 9mm handgun on the dresser, and he shot her in the head. Police said he couldn’t recall exactly what day this occurred, but they believe it was Tuesday.

Meyer said he then left her body in the room for several days before reporting the incident.

He was booked and ordered to be held without bail, facing charges of 1st-degree felony murder and 2nd-degree felony obstruction of justice for waiting several days to report his wife’s death.

He also told police that he and his wife used marijuana every night for the past 10 years. Neither of them had medical marijuana cards. Police said this meant he was restricted from possessing firearms, so he also faces two charges of illegal firearm possession. He told police he owned another handgun in addition to the one he allegedly used to kill his wife.

__________

Resources for domestic violence victims/prevention (free, 24/7, confidential):

• Utah Domestic Violence Coalition:
  • Hotline: 1-800-897-LINK (5465)
  • Online help: udvc.org
• National Domestic Violence Hotline
  • 1-800-799-SAFE (7233)
  • Online live chat: thehotline.org
• If you or someone else is in immediate danger, or in an emergency, call 9-1-1 immediately.

__________

For those struggling with thoughts of suicide, the National Suicide and Crisis Lifeline can now be reached by simply dialing 988 any time for free support. Resources are also available online at utahsuicideprevention.org.

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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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