State Pharmacy Board meets to discuss Walgreens closures

https://wgme.com/news/local/state-pharmacy-board-meets-to-discuss-walgreens-closings

PORTLAND (WGME) — The state is taking action in the face of sudden disruptions at Walgreens pharmacies.

The group that regulates pharmacies in Maine met Thursday to talk about the issue.

The issue is going before the State Pharmacy Board because the closures are repeatedly happening at the same locations.

It’s impacting people’s access to vaccines, COVID testing and medications.

“This is the most unusual grouping of reports,” Office of Professional and Occupational Regulation Administrator Geraldine Betts said.

When pharmacies change their hours to their posted schedule, the State Pharmacy Board has to be notified.

If that happens four or more times in a calendar month, the board can eventually require the site to change its hours.

“The board has, not that I recall, ever gone into that,” Betts said.

The repeated problems discussed Thursday reportedly happened at 13 Walgreens pharmacies from Buxton to Bar Harbor, Lewiston to Brunswick.

One site in Auburn was closed nine times in October.

“Always closed, but it’s happening all around town though,” pharmacy customer Melissa Fisher said. “There’s not enough people to keep it open.”

The location on Congress Street in Portland closed four times in October and another four times in August.

“When you call, they say they’re open, but when you get here, they’re not open,” Fisher said.

Others were shocked it was such an issue.

“Anna the pharmacist, I’ve seen her work from open to close day after day after day,” pharmacy customer Peter Winchester said.

All of the reports presented to the board blamed staffing problems.

“Did I hear this was happening with other chains and or individual pharmacies as well?” Pharmacy Board Member Tim McCormack said.

“We have not seen reports from others just yet,” Betts said.

That is something the state is looking out for, but so far, the problem seems limited to Walgreens.

“We’re kind of tired of using the term ‘unprecedented times,’ but I’ve been doing this for 20 years and have never ever seen it as tough as it is,” Pharmacy Board President Brad Hamilton said.

The state is going to remind Walgreens that it has to clearly post changes to the hours and customers have to be notified of another nearby location that can help.

The state has already reached out to the chain to get more info about why this is happening.

The board even discussed having a meeting with a representative.

In a statement to CBS13, Walgreens said, “We apologize for any inconvenience to our customers and patients, as we have adjusted pharmacy hours in our stores to accommodate current staffing needs, while also working to ensure minimal disruption to our customers. “

The pharmacy chain added that it was proud of the extraordinary efforts of its pharmacy and store teams.

“Throughout this greater demand for COVID-related services, they are working to ensure that our patients and customers are cared for, even as we address staffing challenges due to the ongoing labor shortage. What we are seeing currently is consistent with what many other healthcare entities have been experiencing,” Walgreens said. “We’ve expanded our recruitment efforts amidst a pronounced labor shortage, and we’re taking every step possible to help meet current heightened demand for COVID-19 vaccinations, as well as testing and other pharmacy services.”

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Mom Is Suing Hospital for Performing an Emergency C-Section Without Anesthesia

https://www.parents.com/pregnancy/giving-birth/mom-is-suing-hospital-for-performing-an-emergency-c-section-without/

A woman and her fiance are suing Tri-City Medical Center in Oceanside, California after she says doctors performed an emergency cesarean section on her without anesthesia.

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When Dallas PD gave its K9 unit dog, Ballentine, kudos for sniffing out a suitcase containing more than $100,000, many criticized the department for its practice of civil asset forfeiture. The process allows law enforcement officers to seize assets they believe to have been involved with a crime.

However, officials also reported the 25-year-old owner of the suitcase was neither arrested nor charged with any crime.

According to CBS DFW, Dallas police “did not give any details about the nature of the follow-up investigation, what led to the seizure, which techniques and tactics were utilized, nor which Federal partners were involved.”

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Many of you may remember a “gentleman” in Dec of 2019 that posted on FB that he was having his family come to visit him at Xmas when he was going to start a suicide by starvation. At the time, I did blog about him and the trouble that he was having getting adequate pain management.  As Xmas came and went and it became apparent that he appeared to be nothing more than scammer and con artist and appeared to be a “virtual panhandler”.  The first of Jan 2020, I pulled down the blog post and replaced it with a post about what a “person” was doing to the chronic pain community… no names mentioned. I concluded that I was giving him too much exposure and visibility to the chronic pain community via my blog. I did not want those in the community that I was endorsing what he was doing,

A month or so ago, I got a DEMAND that I take that two yr old  post down from this “gentleman”… Knowing what he had done to those in the chronic pain community over the last two years.. I was not sure what he was up to… but.. did not want to destroy what I did – or did not – post about anyone… So I put a password on the post and made it private.  Apparently, from what I have been told  – that caused him to get his panties in a knot.

I have been told that he contacted some legal aid services, wanting to sue me, and I am told that he was told that HE HAD NOTHING !!!

Apparently this “gentleman” was not done with his vindictiveness … Apparently he “stirred up” is harem of minions … getting them to file a untold number of complaints with FB about my blog being a SPAMMER.  Since FB apparently does not verify any such complaints … just reacts and declared my blog as a SPAMMER and has removed AT LEAST any reference to my blog anywhere on FB in 287 posts and 17 comments…

I have been told recently that some of the people that fell for his “virtual panhandling shtick” over the last two years and have called the authorities on his “virtual panhandling ” over the last two years…  and at least a couple of them have been interviewed by the FBI.  How many have reached out to the authorities, I don’t have a exact number or even a educated guess.  I was even told that his girlfriend/wife has even turned him in…  I guess to try to CYA herself.

I have not heard from the FBI, maybe because all I know is what has been shared with me second or third hand… If even HALF of what has been shared with me is true…this “gentlemen” may be on the way to getting “three hots and a cot”, but on the positive side…  the Supreme Court ruled years ago that the 8th Amendment (no cruel and unusual punishment) ONLY APPLIES TO PRISONERS…. so maybe his pain will get addressed properly in the future ?

My blog is up and running, mainly because I own the domain that my blog is on…  no one has any ability to censor or ban me there.

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We met with Dr’s and Medtronics this morning with minor child..7 years old with Spinal Bipita and a few other issues. Child walks on all 4″s as her little spine is very crooked! (Poor Baby) Medtronics is willing to try a pain pump but needs to have a corporate meeting and have several discussions on plan of attack as Child has many bad spots in her spine. Child will start an opioid theropy program recommended by our own Steve Ariens RPH! I was really impressed with the hoops everyone seems to be jumping through all of a sudden. Child was taken to Observation Center and was monitored and Re-Checked before she is sent home!

Child’s mom text me about 20 minutes ago and said she was doing awesome and they will set up next appointment for February with Medtronics and myself!

I’m more surprised at this outcome more so than the first 2! We struggled on medication but Steve Ariens RPH is the man!  He finally broke the tie and the argument the 3 doctors were having  We obviously found a good combo with meds I never heard of and they seem to be working great! Yay  APDF is 3 for 3 with these children  So proud of my APDF team! 1 more to go next Wednesday (fingers crossed) 4 for 4 would be awesome 

American Pain and Disability Foundation is run entirely by VOLUNTEERS and funding is done by Donations.  Now in its THIRD YEAR,  volunteers are coming together in “small teams” to work for the improvement in the QOL of pain pts.  Each team with individuals with complimentary and synergistic talents and each team working on different areas to collectively address improving pain management for the pain community as a whole. There is no one “SILVER BULLET” or “MAGIC WAND” to get the community from here and now to that point in the future where sanity returns to the appropriate treatment of pain.

https://americanpaindisabilityfoundation.org/

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Pfizer Study Shows Vaccine Booster Should Protect Against Omicron

https://www.medscape.com/viewarticle/964431

A raft of new studies released overnight that looked at the ability of Omicron to evade an array of currently available vaccines, suggest a substantial loss of protection against the highly mutated variant.

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in an afternoon press briefing.

More Research Needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing today that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.

Retool the Vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant.  In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending US Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the Department of Microbiology at the Mount Sinai School of Medicine in New York City.

Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering.  “I am worried.”

On Wednesday, Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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Supreme Court Set to Weigh in on the Opioid Epidemic in Three Important Physician Cases

https://medium.com/@fightthefeds/supreme-court-set-to-weigh-in-on-the-opioid-epidemic-in-three-important-physician-cases-c5b6cc0219eb

The Supreme Court will decide United States v Ruan and United States v. Kahn and likely United States v. Naum and determine if a physicians prosecuted by the federal government can be convicted for violating an objective standard of care.

United States v. Naum

A few years ago, I spent over a month in Northern West Virginia defending a doctor accused of unlawfully prescribing Opiates — specifically Suboxone. A family practice physician running a small clinic in Northern Ohio and West Virginia Dr. George Naum wanted to help patients suffering from the opioid epidemic by providing medication assisted treatment. In small rural communities this service was needed to help those suffering from addiction begin their recovery and start getting their life back together. Dr. Naum joined a practice and began working with a nurse to treat this vulnerable patient population.

Fast forward a few years and Dr. Naum found himself in the middle of a federal investigation for, of all things, unlawfully prescribing opiates. The practice was not a pill mill. It was a treatment center. The practice was not prescribing high power narcotics to patients seeking opiates or unlawful purposes but rather a place where people recovering from addiction sought treatment. Unfortunately for Dr. Naum, federal prosecutors not trained in the complexity of healthcare law and medical treatment failed to understand the difference.

To make matters worse, the standards for prosecuting physicians became convoluted over time by federal appellate court decisions that failed to recognize sometimes Doctors are required to make tough calls in the wake of the opioid epidemic. Knowing that Dr. Naum had done nothing wrong we proceeded to trial and were quick to learn that both the prosecutor and the judge stacked the case against us by making a critical error in interpreting Controlled Substance Prescribing laws.

Decided in 1975 the landmark case of United States v. Moore was the first case that determined that the weight of the federal government’s drug trafficking laws could be applied against physicians. To be convicted, a doctor must have abandoned the practice of medicine, ceased acting as a physician, and engaged in drug trafficking as conventionally understood i.e., running a “pill mill”. Since United States v. Moore circuits have widely spilt in their interpretation of the standard necessary to convict a Defendant. In the Fourth Circuit courts determined that a physician could be convicted of drug trafficking if he or she prescribed a medication “beyond the bounds of professional medical treatment”. The Circuit court interpreted this to mean that any doctor who prescribes outside of “professionally recognized norms” may be convicted of Drug Trafficking.

The Court in Dr. Naum’s case determined that Dr. Naum could be convicted if he stepped outside of professional norms for prescribing Suboxone regardless of whether the patients had a legitimate medical need for the treatment. Given that it’s nearly impossible for every doctor to follow the myriad of rules and regulations applied explicitly and in an ad hoc fashion Dr. Naum was convicted. Nearly every practitioner without a robust compliance program and a team of compliance professionals would be. Dr. Naum appealed, all the way to the Supreme Court of the United States.

Meeting Dr. Naum at the Supreme Court was another case, that of Xiulu Ruan. Dr. Ruan was a board-certified interventional pain management specialist in Mobile Alabama. He owned the practice along with his partner John Patrick couch, whom I am also representing before the Supreme Court. Drs Couch and Ruan were indicted in 2016 for unlawfully prescribing drugs. Just as in Naum, the prosecutors acknowledged that the patients, by in large, needed the medications prescribed but they prosecuted them anyway for falling outside of professional norms. The Government elicited testimony from three experts who testified at length that both doctors prescribed medication “outside the standard of care” and “outside the usual course of practice”. Back in 1975 such testimony would not be sufficient to support a criminal conviction. Today its much different. The standard has been sufficiently eroded to achieve convictions against doctors making tough judgment calls in the pain management field.

The Legal Standard Has Changed

In all three cases, medical “experts” brought by the government faulted the physicians for: ignoring “red flags”, not conducting a thorough examination, using opiates as a first line of treatment, not abandoning patients who presented inconsistent urine drug screens. The practice of opening up a physician’s medical records and heavily criticizing care based on an unenumerated list of “red flags” or professional norms is something that has sent a lot of innocent doctors to the slammer. Moreover, each physician, Naum, Ruan, and Couch, called experts of their own who were well credentialed and supported the care provided. None of these cases presented the sort of rampant “pill mill” evidence commonly seen in prosecutions of this nature in the early 2000’s.

Similarly, to Naum, Ruan and Couch were the victims of a judicial decision that drastically changed the standard for conviction presented to the jury and stacked all odds against them. In Ruan and Couch the trial court refused to provide a commonly provided instruction that informed the jury that prescriptions written by the doctors “in the good faith treatment of a patient” are lawful. Without the benefit of the “good faith” defense, minor differences between the standard set forth by government experts and the prescribing practices of Ruan and Couch became criminal, just as in Naum.

Ruan and Couch requested the following instruction:

“Good faith in this context means good intentions and the honest exercise of professional judgment as to the patient’s needs. It means that the Defendant acted in accordance with what he reasonably believed to be proper medical practice”

This instruction was a mainstay in opioid prosecutions until a few years ago when the government elected to take the position that the instruction was not a valid statement of the law. The government argued that “good faith” was “subjective” and the standard should be an objective one. The court ruled that a physician cannot save his conduct if he failed to adhere to professional norms but subjectively believed that his prescriptions were legitimate.

All three physicians sought the review of the high court to change the state of law for good. All three physicians sought to stop the prosecution of physicians for what amounted to allegations of mere malpractice and revert to the standard set in 1975 by United States v. Moore.

On November 5, 2021 the Supreme Court agreed to hear the appeal of Ruan v. United States and consolidated the case with a very similar case Kahn v. United States. Naum v. United States is still pending before the court and may be taken up later if the decision in Ruan does not dispense with the issues in his case.

The Supreme Court’s Decision

Ruan will be set for oral argument this term and the Justices have elected to decide the very narrow issue of whether the “good faith” defense to opiate prescribing is a valid defense and whether an instruction must be given to the jury. The Court will likely opine on whether a physician’s subjective “good faith” is a relevant consideration for a jury in opioid prosecutions. If the Court determines that “subjective good faith” is relevant, doctors making tough decisions during medical treatment of a patient will get a break. If the Court determines that it is not, doctors will be beholden to the rigid, ever changing, and often unenumerated standards often used by physicians in opioid prosecutions.

While the ruling may be narrowly applied to the issue of “good faith” it will require an analysis of the state of the standard for prescribing opiates and the ruling will have wide ranging implications for all doctors prescribing controlled substances to patients and how they must document their prescriptions to avoid federal scrutiny for their prescribing decisions.

What this Means for Pain Practices

The Court’s decision will either strengthen existing opioid prescribing laws and enable prosecutors to use them against physicians who merely deviate from the “standard of care”, or it will sway to the benefit of prescribers allowing them the benefit of a jury instruction that makes judgment calls made in “good faith” a defense. Regardless, all prescribers should be watching this case and read the court’s dicta very carefully to ensure that their practices stay compliant with the current interpretation of federal regulations in this field.

About the Author

Ronald Chapman II, ESQ @RonChapmanAtty is an author and nationally-recognized top federal criminal defense attorney, and former prosecutor, with a number of high-profile federal acquittals. “Fight the Feds: Unraveling Federal Criminal Investigations” is available for pre-order now. If you are interested in contacting Ron about a case, contact him here: Chapman Law Group

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APDF’s  VP Bob Sherrin a pediatric pain advocate …met today with this pt’s prescriber and her parents and after over six weeks of suffering from 3rd degree burns and painful debridement WITHOUT ANY OPIATES FOR HER  PAIN …. she got her first opiate Rx and her first dose today. Up until today, Vanderbilt Hosp had a BLANKET NO OPIATE POLICY for pediatrics.

IMO, the chronic pain community and American Pain & Disability Foundation IS ON THE MOVE

APDF needs both volunteers and donations

Vanderbilt Burn Center (Nashville) refused to provide the young patient sufficient pain medication for SIX WEEKS

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