Walgreens seeks to dismiss state regulators’ complaints on closures, insurance billing

I am surprised that BOP did not drag the Pharmacy manager (PIC) into this, unless he/she had resigned, because technically they are responsible to the BOP for the legal operation of the Rx dept. Walgreens has a permit to have a Rx dept – as long as their is a pharmacist that is appointed to be PIC. I know that the Walgreens closest to us, that was a 8 AM to midnight hours of operation.  That store had 3 pharmacists and either they all walked out the same day or in the same week. They parked cars in the drive thru and my understanding is that the Rx dept would open when they could find a single pharmacist and technician to work – maybe as little as 5 hrs… and when their shift was over… the next time that the Rx dept would be staffed again… there was no/little certainty.  From what I was told this “white coat flu” was nearly epidemic in the greater Louisville, KY area in particularly in the major chain pharmacy stores. In the 20 yrs that we had our independent pharmacy, there one only ONE DAY that the pharmacy did not get opened. Having a 20 ” snow  ( year’s worth of snow in < 24 hrs) and 30-40 MPH winds caused a lot of roads to become impassible.  Out where we live in the county, they have to bring BULLDOZERS out to clear our roads.  There was a section of the road that we lived on, was drifted some 12′-15′ deep. My little ’73 Pinto station wagon was not up to the task.

Walgreens seeks to dismiss state regulators’ complaints on closures, insurance billing

https://www.benningtonbanner.com/local-news/walgreens-seeks-to-dismiss-state-regulators-complaints-on-closures-insurance-billing/article_7972cb54-24b3-11ed-be0f-ebeae1c5f7ed.html

MONTPELIER — Walgreens Co., in its response to a complaint by the state about the unplanned closures of pharmacies and the effects on customers, has asked the Vermont Board of Pharmacy to dismiss the complaint entirely.

It’s the first of what’s likely to be an avalanche of legal motions in what is now a quasi-judicial process. Until and unless the Vermont Office of Professional Regulation and Walgreens settle the allegations, the Board of Pharmacy must decide whether to discipline Walgreens for a laundry list of alleged violations at its 32 locations across the state, including in Brattleboro, Bellows Falls, Wilmington, Bennington and Manchester. That could include sanctions up to and including loss of license.

Walgreens, which had been given an additional month to respond to the allegations, replied with a motion to dismiss the complaint “with prejudice” — that is, preventing them from being refiled — and a motion to stay its deadline to respond. The pharmacy chain originally faced a July 20 deadline, which was pushed forward to Aug. 20 at Walgreens’ request.

In its motion to dismiss, Walgreens said the state had overreached in its assertion that many of the company’s stores had not met professional standards, that the statute governing the operation of pharmacies is vague, and that the allegations violate Walgreens’ due process rights. The motion was filed by White River Junction attorney P. Scott McGee on behalf of Washington, D.C.-based Quarles and Brady LLP.

“In the context of the uncertainty and instability caused by the pandemic, [Walgreens] provided reasonable care to its patients while grappling with contingencies that impacted pharmacists nationwide. Despite this, [the Vermont Office of Professional Regulation] is attempting to unfairly hold [Walgreens] to a nearly impossible standard of care under the circumstances and seeks to discipline [Walgreens] for unprecedented circumstances,” the motion said.

It further claims that the state “unilaterally — and without notice — determined that [Walgreens’] pharmacy closures are in violation of law.”

While the state acknowledges the closures were unexpected and temporary, “even though [Walgreens] pharmacies were mostly open and serving the public during a pandemic, [the Office of Professional Regulation] unreasonably seeks to penalize [Walgreens] for unexpected closures,” the motion argues.

The initial 40-page complaint alleges that the company unreasonably restricted consumer access to medication and hardship to customers by closing stores without notice; that it failed to comply with federal and state professional standards; and that it engaged in “conduct of a character likely to deceive, defraud or harm the public.”

The complaint further alleges Walgreens “failed to comply on an egregious scale” with state law by operating stores without a pharmacist-manager present, including locations in Bellows Falls and on Canal Street in Brattleboro, and did not identify or address working conditions that jeopardized patient care.

The state complaint also alleges that Walgreens’ computer system continued to order refills and charge customers’ insurance for medications they could not access because the store was closed. That led to customers scrambling to find another pharmacy that would fill the script — and in some cases, led to customers paying out of pocket at significant expense.

Incidents in Southern Vermont included unexpected closures in Brattleboro and Manchester that led to customers driving significant distance for prescriptions; insurance billing for medications that were not available because of the closures, meaning consumers had to pay out of pocket; and continued billing for prescriptions in Manchester, despite that pharmacy being closed after a fire.

The state’s response to the motion to dismiss is expected to be filed next week, according to S. Lauren Hibbert, director of the Office of Professional Regulation.

The state did respond to Walgreens’ motion for a stay on its response, saying it’s neither allowed by administrative rules nor warranted.

“Walgreens has already had additional time, almost eight weeks, to, in its own words, ‘determine the facts and provide a full and accurate response to each of the charges,’” attorney Jennifer B. Colin said on behalf of the Office of Professional Regulation. “The filing of Walgreens’ answer has already been delayed to allow respondents adequate time to gather facts and respond substantively to each of the specifications.”

Despite all the legal motions, the complaint is not before a civil or criminal court. Rather, it’s up to the Board of Pharmacy to act as jury in the matter, with a judge hired for the proceedings and administrative law officers appointed to assist the board. Retired Washington County Probate Judge George Belcher has been retained as the presiding officer in the matter.

The state Board of Pharmacy has eight members, who are appointed by the governor’s office.

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

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

https://www.vice.com/en/article/wxnyb9/dea-fentanyl-doctor-patient-suicide

“There are millions of chronic pain patients suffering just like me,” Danny Elliott wrote before ending his life. “Nobody cares.”
Danny and Gretchen Elliott, seen in an undated photograph.
Danny and Gretchen Elliott, seen in an undated photograph. Provided photo.

It was a Tuesday in early November when federal agents from the Drug Enforcement Administration paid a visit to the office of Dr. David Bockoff, a chronic pain specialist in Beverly Hills. It wasn’t a Hollywood-style raid—there were no shots fired or flash-bang grenades deployed—but the agents left behind a slip of paper that, according to those close to the doctor’s patients, had consequences just as deadly as any shootout.

On Nov. 1, the DEA suspended Bockoff’s ability to prescribe controlled substances, including powerful opioids such as fentanyl. While illicit fentanyl smuggled across the border by Mexican cartels has fueled a record surge in overdoses in recent years, doctors still use the pharmaceutical version during surgeries and for soothing the most severe types of pain. But amid efforts to shut down so-called “pill mills” and other illegal operations, advocates for pain patients say the DEA has gone too far, overcorrecting to the point that people with legitimate needs are blocked from obtaining the medication they need to live without suffering. 

One of Bockoff’s patients who relied on fentanyl was Danny Elliott, a 61-year-old native of Warner Robins, Georgia. In March 1991, Elliott was nearly electrocuted to death when a water pump he was using to drain a flooded basement malfunctioned, sending high-voltage shocks through his body for nearly 15 minutes until his father intervened to save his life. Elliott was never the same after the accident, which left him with debilitating, migraine-like headaches. Once a class president and basketball star in high school, he found himself spending days on end in a darkened bedroom, unable to bear sunlight or the sound of the outdoors. 

“I have these sensations like my brain is loose inside my skull,” Elliott told me in 2019, when I first interviewed him for the VICE News podcast series Painkiller. “If I turn my head too quickly, left or right, it feels like my brain sloshes around. Literally my eyes burn deep into my skull. My eyes hurt so bad that it hurts to blink.”

After years of trying alternative pain treatments such as acupuncture, along with other types of opioids, around 2002 Elliott found a doctor who prescribed fentanyl, which gave him some relief. But keeping a doctor proved nearly impossible amid the ongoing federal crackdown on opioids. Bockoff, Elliott said, was his third doctor to be shut down by the DEA since 2018. As Elliott described it, each transition meant weeks or months of desperate scrambling to find a replacement, plus excruciating withdrawals due to his physical dependence on opioids, followed by the return of that burning eyeball pit of despair.

After the DEA visited Bockoff on Nov. 1, Elliott posted on Twitter: “Even though I knew this would happen at some point, I’m stunned. Now I can’t get ANY pain relief as a #cpp [chronic pain patient.] So I’m officially done w/ the US HC [healthcare] system.”

Privately, Elliott and his wife Gretchen, 59, were frantically trying to find another doctor. He sent a text to his brother, Jim Elliott, saying he was “praying for help but not expecting it.” 

Jim, a former city attorney for Warner Robins who is now in private practice, was traveling when he received his brother’s message. They made plans to talk later in the week, after Danny had visited a local physician for a consultation. In subsequent messages, Danny told Jim that Gretchen had reached out to more than a dozen doctors. Each one had responded saying they would not take him as a patient.

Jim recalled sensing in Danny “a level of desperation I hadn’t seen before.” Then, on the morning of Nov. 8, he woke up to find what he called “a suicide email” from his brother. Jim called the local police department in Warner Robins to request a welfare check. The officers arrived a few minutes before 8:30 a.m. to find both Danny and Gretchen dead inside their home. 

A police report obtained by VICE News lists a handgun as the only weapon found at the scene. Warner Robins police said additional records could not be released because the case is “still active.” The department issued a press release calling the deaths a “dual suicide.” 

IMG_4884.jpg

Jim shared a portion of a note that Danny left behind: “I just can’t live with this severe pain anymore, and I don’t have any options left,” he wrote. “There are millions of chronic pain patients suffering just like me because of the DEA. Nobody cares. I haven’t lived without some sort of pain and pain relief meds since 1998, and I considered suicide back then. My wife called 17 doctors this past week looking for some kind of help. The only doctor who agreed to see me refused to help in any way. What am I supposed to do?”

At a joint funeral for Danny and Gretchen Elliott on Nov. 14 in Warner Robins, mourners filled a mortuary chapel to overflow capacity. Eulogies recalled a couple completely devoted to each other. They were doting cat owners, dedicated fans of Georgia Tech and Atlanta sports teams, and devout Christians, even as Danny’s chronic pain increasingly left him unable to attend church. In photos, the Elliotts radiate happiness with their smiles. But their lives were marred by pain: Gretchen was a breast cancer survivor. She married Danny in 1996, well after his accident, signing up to be his caregiver as part of their life partnership.

“It was a Romeo and Juliet story. They didn’t want to live without each other,” said Chuck Shaheen, Danny’s friend since childhood and Warner Robins’ former mayor. “I understand the DEA and other law enforcement, they investigate and then act. But what do they do with the patients that are no longer able to have treatment?”

Shaheen and Danny both worked in years past for Johnson & Johnson, which is among the companies sued for allegedly causing the opioid crisis. Shaheen was also previously a salesperson for Purdue Pharma, the maker of OxyContin, another company blamed for spreading addiction. But Shaheen said Danny was not among those chasing a high—he, like others with severe chronic pain, was just seeking a semblance of normalcy.

“They’re not doctor shopping,” Shaheen said. “They’re not trying to escalate their dose. They’re trying to function.”

Danny told me in 2019 that the relief he obtained from fentanyl didn’t make him feel euphoric or even completely pain free. He was using fentanyl patches and lozenges designed for people with terminal cancer pain, at extremely high doses that raised eyebrows whenever he was forced to switch doctors. But it was the only thing that worked for him.

“I call it turning the volume of my pain down from an eight or nine or even 10 sometimes to a six or a five,” he said. “The pain doesn’t get much lower than that, but for me, that’s almost pain free. It was the happiest thing I’ve ever experienced in my life.”

There are millions of chronic pain patients suffering just like me because of the DEA. Nobody cares

Gretchen’s brother, Eric Welde, choked up as he spoke with VICE News at the funeral about his perspective on the family’s loss: “In my mind, what the DEA is essentially doing is telling a diabetic who’s been on insulin for 20 years that they no longer need insulin and they should be cured. They just don’t understand what chronic pain is.”

So far, no criminal charges have been filed against Bockoff. In response to an inquiry from VICE News about the deaths of Danny and Gretchen Elliott, the doctor emailed a statement that said: “I am unable to participate in an interview except to say: Their blood is on the DEA’s hands.”

The DEA responded to a list of questions about Bockoff and the Elliotts’ suicides with an email saying Bockoff received what’s known as an “Immediate Suspension Order,” which according to public records is warranted in cases where the agency believes the prescriber poses “an imminent danger to public health or safety.” The DEA said local public health partners were notified in advance to coordinate under a federal program designed to mitigate overdose risks among patients who lose access to doctors. The agency offered no further comment.

Data on suicides by chronic pain patients is scarce, but experts who study these cases estimate that hundreds—perhaps thousands—of Americans have taken their own lives in the aftermath of losing access to prescription opioids and other medications. Some cases have occasionally made news, like a woman in Tennessee who was arrested for buying a gun to assist her husband’s suicide after his doctor abruptly cut down on his medication used to treat back pain.

Starting around 2016, a backlash to prescribing opioids began to spread across the U.S. healthcare system, sparked in part by guidance from the Centers for Disease Control and Prevention (CDC) that prompted scrutiny of patients on doses equivalent to over 90 milligrams of morphine per day.

The National Committee for Quality Assurance, which develops quality metrics for the healthcare industry, has implemented its own 90 milligram threshold, and patients over that baseline count as receiving “poor care,” regardless of their dose history. In practice that means doctors have strong incentives to reduce the dosage, even for someone like Elliott, who had been taking the same prescription for years, and even if it’s not necessarily in the best interests of the patient.

Since 2018, the CDC has developed an initiative called the Opioid Rapid Response Program, which is supposed to assist when doctors lose the ability to prescribe pain medication. Stephanie Rubel, a health scientist in CDC’s Injury Center who leads the program, said when the DEA visited Bockoff’s office, “a healthcare professional was onsite in case any patients arrived for their appointments.”

Rubel, in a statement sent via the CDC’s press office, said everyone from the county health department to Medicare providers were alerted about the DEA’s action against Bockoff. But Rubel also noted that the CDC program “does not provide direct assistance to patients affected by a disruption, including referrals or medical care.” In fact, the only help that patients like Elliott received was a flier with a list of local emergency rooms they could visit if—or when—they started experiencing withdrawal.

“Any loss of life due to suicide is one too many,” Rubel said. “This case is heartbreaking and emblematic of the trauma, pain and danger many patients face when these disruptions occur and is why ORRP [Opioid Rapid Resposne Program] has been developed to help prepare state and local jurisdictions to respond when disruptions in care occur.”

Dr. Stefan Kertesz, a professor at the University of Alabama at Birmingham Heersink School of Medicine, had been acquainted with Danny since 2018, meeting him in another moment of crisis. Danny’s doctor at the time had just been arrested by the DEA, and Kertesz, who conducts research and advocates on behalf of chronic pain patients, stepped in to help. It was difficult, Kertesz told VICE News, because “the doses he was on were orders of magnitude higher than most doctors are familiar with.”

What the DEA is essentially doing is telling a diabetic who’s been on insulin for 20 years that they no longer need insulin and they should be cured

Danny ultimately found another doctor but was forced to change once more before landing with Bockoff in Beverly Hills. Kertesz cautioned that he was not familiar with the details of Bockoff’s case, but said the doctor was known for treating “opioid refugees” who’d been turned away from other physicians. Danny and his wife would fly from Georgia to Los Angeles for appointments, and other patients with unique circumstances came from around the country.

Bockoff had practiced medicine in California for 53 years with no record of disciplinary action or complaints with the state medical board, according to the Pain News Network, which reported the DEA searched the doctor’s office about a year ago but did not take patient records. 

Asked about the DEA’s handling of the Bockoff case, Kertesz replied: “Honestly, it seemed to me like bombing a village. It could be they think they’re getting the bad guy, but it’s not a precision munition. Whoever is launching the bomb has to consider the collateral damage.” 

Clinical research on chronic pain patients is complicated, Kertesz said, but “a lengthy series of studies confirm that there is a strong association between opioid reduction or stoppage and suicide.” While reducing opioid intake can be helpful for some people, he said, Danny and other longtime users with medical needs should not be forced to go cold turkey.

“Even if you believe the doctors did something wrong, I can’t find somebody who believes all those patients should die,” Kertesz said. “And if we agree they shouldn’t all die, then why would we act in such a way that we know we’re going to massively increase their risk of death?”

Another former Bockoff patient was Kristen Ogden’s husband Louis. Much like Gretchen Elliott, Ogden has supported her husband for years as he’s battled chronic pain caused by a rare condition similar to fibromyalgia. And like the Elliotts, the Odgens have dealt with the fallout of DEA actions that triggered desperate searches for new doctors.

The Ogdens live in Virginia and had just landed in California for a doctor’s appointment when they got the news about the DEA’s visit to Bockoff’s office. They found the emergency room flier to be a slap in the face.

“They probably look at you as an addict and they recommend that you do whatever you can to get off these medications,” Ogden said. “They’re not there to help us at all.”

Ogden is the co-founder of an advocacy group called Families for Intractable Pain Relief, and she started reaching out to her network, including other patients. She spoke to Danny by phone and described him as sounding “consumed by this dread of what he fully expected was going to be the next step for his life—months of untreated pain.”

Honestly, it seemed to me like bombing a village

Ogden said she’s personally called at least 10 doctors seeking treatment for her husband but to no avail. Other Bockoff patients are in the same boat, she said, and nobody she knows has been able to find another specialist willing to continue with a similar course of care.

Dr. Thomas Sachy of Gray, Georgia, was the first doctor to prescribe Danny fentanyl and remained his physician until the DEA raided his practice in 2018. Federal authorities have alleged Sachy had his office set up like a “trap house” with firearms on the premises. Sachy is charged with “issuing prescriptions not for a legitimate medical purpose and not in the usual course of professional practice.” Two employees and Sachy’s 84-year-old mother, who worked at his clinic, were also initially charged but their cases have since been dropped.

Sachy agreed to plead guilty in the case to avoid a possible life sentence but later withdrew the plea. He maintains his innocence. His trial is scheduled to start in January in federal court in Georgia. Wearing an electronic ankle monitor to track his location while out on bond, Sachy attended the Elliotts’ funeral service in Warner Robins, where he sat for an interview with VICE News.

Federal prosecutors have accused Sachy of prescribing opioids that contributed to the deaths of patients. Sachy in turn blames the DEA for the suicides of two patients who took their lives in the aftermath of the raid.

“My patients weren’t young drug addicts off the street,” Sachy said. “They were middle-aged and older with health problems. And the thing about pain, chronic pain, and the anxiety and the suffering that comes with it, it wears you down.”

Similar to what happened with Bockoff, after the DEA visited Sachy’s office in Georgia, the only resource made available to patients was a list of local pain management facilities and resources for opioid withdrawal, including emergency rooms. Sachy scoffed at the idea of his patients visiting an ER for help: “They’d look at them like they were insane or criminals or both.”

“It’s absolutely frustrating,” Sachy said. “It’s absolutely heartbreaking. It sucks. It destroys everything you think a physician should do and be and should be able to accomplish. It’s all taken away. And it’s just utter helplessness.”

Among the Elliott family and other pain patients, helplessness and anger remain common sentiments. Ogden said her husband and other chronic pain patients have spoken with an attorney about the possibility of a lawsuit against the DEA.

As a lawyer who worked for years in public office, Jim Elliott knows civil litigation against the government can be an uphill battle. He said the family is still deciding how to move forward in response to the deaths of Danny and Gretchen.

Jim emphasized that “it wasn’t as if pain medication made Danny’s life great.”

Fentanyl just made the pain bearable. And when that was taken away, Danny saw no future.

“He was taking a high level of pain medication but he wasn’t an addict and he wasn’t trying to get high or anything,” Jim Elliott said. “He was just trying to live a life. And they closed every door for people like that.”

If you are in crisis, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255), or contact the Crisis Text Line by texting TALK to 741741.

Is Delay of care…unprofessional conduct ?

PHARMACY LAW QUESTION
I practice at an independent pharmacy. Calling a ******* chain pharmacy averages 10-15 minutes of being on hold before I or my staff ever gets to a person. In response, when the chain pharmacy calls me, I leave them on hold for several minutes so they can see what it is like: frustrating and time-consuming. Recently, a patient saw me do this and asked what was going on. A staff member explained. The patient filed a complaint with the state board of pharmacy.
Am I in trouble?
Quite possibly, yes.
Though PLS understands your frustration and has had the same experience many times, this is what the patient saw:
Delay in care.
Whatever the chain pharmacy was calling about—transfer out, transfer in, patient info, check on drug availability—the result was that some aspect of patient care was put off while you retaliated. “Delay of care” is usually not listed in state pharmacy law as a violation of pharmacy law, but “unprofessional conduct” is.
Unprofessional conduct is defined as conduct that is unethical, dishonest or FALLS BELOW THE STANDARDS OF YOUR PROFESSION. This covers a range of conduct and behavior when we practicing. It is also a reminder that pharmacists have standards of practice to meet due diligence in providing patient care. Not delaying patient care, even for a few minutes, fits into that category.
Should your state board of pharmacy decide your act in leaving the chain pharmacy on hold unnecessarily falls into the unprofessional conduct law, you are going to have the burden of showing that no delay in care resulted from this.
Again, your frustration is understandable and is shared by many of your colleagues. But be professional.

Another thing I am thankful for

https://www.facebook.com/pharmaciststeve/posts/10228477840000292

MICHIGAN VS. OHIO STATE: LOW HANGING FRUIT AND THE DEA TARGETING OF YOUR HEALTHCARE PROVIDER

MICHIGAN VS. OHIO STATE: LOW HANGING FRUIT AND THE DEA TARGETING OF YOUR HEALTHCARE PROVIDER

REPORTED BY

youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

Neat, Plausible, and Generally Wrong:
A Response to the CDC Recommendations for Chronic Opioid Use

BY

Stephen A. Martin, MD, EdM;
Ruth A. Potee, MD, DABAM; and
Andrew Lazris, MD

STEPHEN A. MARTIN, MD, EdM

Abstract:

“The American crisis of opioid addiction and overdose compels our strongest efforts toward successful prevention and treatment. Recommendations from the Centers for Disease Control and Prevention (CDC) for chronic opioid use, however, move away from evidence, describing widespread hazards that are not supported by current literature. This description, and its accompanying public commentary, are being used to create guidelines and state-wide policies.

These recommendations are in conflict with other independent appraisals of the evidence — or lack thereof — and conflate public health goals with individual medical care. The CDC frames the recommendations as being for primary care clinicians and their individual patients.

Yet the threat of addiction largely comes from diverted prescription opioids, not from long-term use with a skilled prescriber in a longitudinal clinical relationship. By not acknowledging the role of diversion — and instead focusing on individuals who report functional and pain benefit for their severe chronic pain — the CDC misses the target.

We provide here a review of the evidence regarding long-term opioid use for chronic pain in order to a) better point public health efforts, and b) reduce harm from consequent restriction of these medications for patients who have substantial benefit in their use.”

LOW HANGING FRUIT

A REPUBLICATION OF MS KATHERINE ROSENBURG-DOUGLAS’S STORY AND THE DRUG INDUSTRIAL COMPLEX WHICH WITHHOLDS PAIN MEDICATION PRESCRIBED BY YOUR DOCTOR
Column: “…Condemn the opioid epidemic, sure…but remember those of us in chronic pain who need help.”
KATHERINE ROSENBERG-DOUGLAS

KATHERINE ROSENBERG-DOUGLAS

CHICAGO TRIBUNE |JUL 12, 2019 AT 7:34 PM

“I broke my back while Rollerblading when I was 21. After three surgeries beginning at age 30, I’ve recovered enough that I’ve gone on to what looks like a normal life. I’m a married mother of twin 4-year-olds, so I am relatively stressed, but fortunately, I’m otherwise relatively healthy.

I’m also on a fentanyl patch delivering slow and steady pain relief to keep me feeling like I can get out of bed, and morphine for breakthrough pain when life requires more of me than merely getting out of bed — and anyone who has ever had a 4-year-old knows each day is far more demanding than that. Just driving my kids to school or sitting for longer than 20 minutes at a time is a struggle.”

 

“I DON’T FEEL COMFORTABLE”

Joseph L. Webster MD SR., MD, MBA, FACP, BS. PHARMACY:

” It is not the purview nor is the pharmacist trained to ‘challenge the diagnosis of the physician and to do so verbally or otherwise with the patient. It erodes the ‘doctor-patient relationship and destroys the ‘confidence’ of the patient in his/her physician. At the very least it is ‘unethical’ and may very well be a HIPPA violation and beneath the standard of care as a pharmacist.”

THE PHARMD, “SECOND GUESSING A PROVIDERS DIAGNOSES”

‘THE MOST DANGEROUS TYPE OF PHARMACIST’

AND THEIR FAILURE TO UNDERSTAND THE PATHOPHYSIOLOGY OF PAIN

Pain and pain management is a very complex issue. More often than not in chronic (non-acute) pain which is considered a disease, comorbidities need to be addressed. The “uncomfortable pharmacist,” has failed to develop a basic understanding of pain pathophysiology and neuroscience and the basic structures and function of the Nervous System which is a complex structure that coordinates voluntary and involuntary actions by transmitting signals to and from different parts of the body.

LESLY POMPY MD, ON TRIAL MONROE MICHIGAN LOW HANGING FRUIT

https://video.foxnews.com/v/5977750216001

“ The American Medical Association strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denial of legitimate medications”

https://www.foxnews.com/health/doctors-abandon-opioid-prescribing-as-state-and-federal-authorities-step-up-enforcement

LOW HANGING FRUIT

The American Medical Association wrote on June 16, 2020:

While the AMA understands that the apparent goal of the Centers for Disease Control (CDC) Guideline was to reduce opioid prescribing, we believe the proper role of the CDC is to improve pain care. Therefore, it follows that a dedicated effort must be made to undo the damage from the misapplication of the CDC Opioid Guidelines.

We are concerned that such a careful approach to identifying the precise combination of pharmacologic options could be flagged on a prescription drug monitoring program as indications wrongly interpreted as so-called “doctor shopping” and cause the patient to be inappropriately questioned by a pharmacist. The AMA strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denials of legitimate medication.”

Josh Bloom, ACSH’s Director of Chemical and Pharmaceutical Science:

In today’s anti-opioid climate, a “one-size-fits-all” mindset has become the foundation of government-dictated medicine. And it’s awful medicine. For example, the deeply flawed policies enacted as law all over the country are based on the “one-size-fits-none” concept of morphine milligram equivalents (MME) – the maximum amount of an opioid medication that is permitted per patient per day.

https://www.cato.org/multimedia/cato-daily-podcast/follow-science-opioids

IN FACT, the CDC MME chart, the entire concept of morphine milligram equivalents may be convenient for bureaucrats. Still, because of differences in the absorption of different drugs into the bloodstream, half-life of different drugs, the impact of one or more other drugs on opioid levels, and large differences in the rate of metabolism caused by genetic factors are not only devoid of scientific utility but actually causes far more harm than help by creating “guidelines” that are based upon a false premise. When a policy is based on deeply flawed science, the policy itself will automatically be fatally flawed. It cannot be any other way.
Table 1. MME equivalents. Source: CDC

While MME values are touted as useful predictors of the total “opioid load” that a patient can receive, they are nothing of the sort. And MME-based policies don’t just fail because of differences in the size of patients; they fail for multiple reasons.

1. Flawed science yields meaningless results

Morphine is normalized to 1.0 and the conversion factor reflects the relative potency of other opioid drugs. So, if the daily MME – the maximum dose of a drug allowed – is 90 mg. This assumption could not be less accurate. Once we see the profound differences in the properties of the drugs and the difference between individuals who take them it becomes clear that not only is the CDC chart flawed, but the MME is little more than a random number.

2. Not all opioids are created equal, especially in the body

Anyone with even a passing knowledge of pharmacology would immediately be skeptical of data in the chart. Bioavailability. One of the many pharmacokinetic properties required to establish how a drug will fare within the body is called bioavailability – a critical determinant for whether a drug will be effective if taken orally.

3. Bioavailability is a measure of how well a pill will be absorbed in the gut and subsequently enter the bloodstream.

4. Half-life and metabolism

Although critical, bioavailability is far from the only measure of an oral drug’s effect on people or animals is primarily metabolized by two different cytochrome P450 enzymes called 3A4 and 2D6.

The difference in metabolizing enzymes itself is a substantial concern when comparing two different drugs, but it becomes even more so when other drugs are part of the picture. The only certainty is uncertainty

“NOT AT WALGREENS”

PROMOTING MEDICATION SAFETY

Most opiate pain medication when abused are not used by the individual to whom the medication was prescribed. In this country only health care providers and pharmacies are authorized to dispense medications.

However how many individuals have received medications from relatives or friends. Unfortunately it is a common practice and no one even thinks they are breaking the law and are a factor in the opiate epidemic.

We need to devise a simple common sense method to return unused medication including opiate pain medication to the physician who wrote the prescription or the pharmacy who dispensed the medication. Just like we have state drug monitoring programs, we need a state prescription disposal system. This should be easily done.

Once the prescribed medication has exceeded the time it was prescribed for the patient should be notified by the pharmacy and the prescriber that their medications has exceeded the period it was prescribed for. All unused medications has to then be accounted for. Did the patient use all of the medication?

Does the patient need a refill? If the patient needs a refill the prescriber can give him a appointment. If the patient doesn’t need a refill any and all unused medications should be returned to the prescriber or pharmacy. If we build this into our health care system, the accidental use of all unused medication will be eliminated.

Walter F. Wrenn III M.D.

LOW HANGING FRUIT

THE RED FLAG – Distance

The DEA has developed criminal elements of free commerce by criminalizing distance travel as an element of criminal conduct. Whereby a pharmacist is a licensed practitioner who has advanced knowledge of the chemical-physical properties of medications, mechanism of actions, their dosage forms design, will likely not refer to GOOGLE MAPS as an element of patient treatments.
OPE’RA, PARIS, lie-de-France, France September 4, 2017

More dangerously, as a result of the DEA’s aggressive policing of community pharmacies many are reluctant to fill any legitimate narcotic analgesic medication prescriptions for non-acute pain patients.
TRAUMATIZING THE AFFLICTED

In the exploring role and purpose of the DEA that acts as an unregulated medical agency policing the medical profession without legal standards and grounds.
GUN SHOT WOUND

The DEA Diversion Investigator claims in arbitrary reasoning; their actions are based on factors applied that “traveling long distances to fill prescriptions can be a red flag of abuse and diversion if a patient travels a significant distance to a particular pharmacy.
REBBECCA

Some patients are known to spend days on end looking for a pharmacy to fill their prescriptions to no avail. This has caused massive concerns in the chronic pain disease medical/dental community, where one of the most important goals of any therapy is continuing staple treatment without disruptions.

DEA GUIDELINES PROMOTE DISPARITY

It is well understood amongst medical/dental practitioners when disruptions in therapy occur, many of the deleterious effects are likely to happen. For example, patients diagnosed with Sickle Cell Anemia are many times profiled as addicts, rather than as persons with a chronic disease condition needing treatment for pain.
BULLET WOUND WHERE RIGHT ELBOW WAS DESTROYED (PRONTO PHARMACY 05/18)

Other examples include persons who have survived traumatic accidents such as automobile accidents, gunshot wounds (civilian and military), notwithstanding leukemia, and other cancers.
CANCER OF LEG 9/29/17 PRONTO PHARMACY

Indeed, pain management becomes even much more difficult when anxiety and diminished mobility complicates the treatment plans.

Further, it is well understood, when both medical/dental practitioners and patients can locate a Pharmacy that will fill pain control prescriptions with dignity and respect, both parties will often share that information with others. Most importantly however, “red flags” are guidelines created by DEA in which the agency “lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine and further lacks authority to promulgated new regulations regarding the treatment of pain. (see Clement vs. DEA case 22-600 awaiting review for certiorari before United States Supreme Court) See Id. Sadly, when challenged in court, the DEA hides behind the great deference awarded to administrative agencies.
Pain you can’t see

Ms. Rosenburg-Douglas further wrote:

” I have a number of diagnoses. Failed back syndrome, a medical term that means just what it says and suggests surgery didn’t help. A “bone stimulator” was implanted during one surgery to encourage growth between pieces of cadaver bone and my own vertebrae, but too much bone grew in around my sciatic nerve, giving me sciatica, or a burning sensation from my rear down my left leg to my toes, which often are numb and tingling (I take another medication for nerve pain).
A monitor shows pain management specialist Dr. Richard Caner performing a spinal injection procedure on Chicago Tribune reporter Katherine Rosenberg-Douglas on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has needed opioids to control severe pain for more than a decade. (Erin Hooley / Chicago Tribune)

My left leg has so much atrophied muscle that it drags behind my right and I had a pronounced limp, but the fentanyl patch largely has eliminated that by providing more steady pain relief. I am disabled, but no longer outwardly appear so, which, along with my age, probably accounts for the daily dirty looks people shoot me when I park in handicapped spaces.
Chicago Tribune reporter Katherine Rosenberg-Douglas is helped to her ride from friend Courtney Holbrook with the help of medical assistant Mario Flores after undergoing a spinal injection procedure on July 2, 2019. The use of a fentanyl patch has helped to correct a pronounced limp. (Erin Hooley / Chicago Tribune)

I understand why police, politicians, and many doctors want to combat the opioid epidemic, but I’m tired of people throwing around that term and lumping me in with a group of drug abusers.

I support the spirit behind their efforts, but can’t support any more regulation on controlled substances. We have now overcorrected, and anyone who requires pain medicine is looked upon as a criminal.

It was once hard to imagine being in more pain than I am, but the current regulations added a new layer of suffering. Please remember opioids exist for a reason and don’t let it get any more difficult for those already in agony”

FOR NOW, YOU ARE WITHIN

THE NORMS

LOW HANGING FRUIT

DEA STAY OUT ON MEDICAL PAIN CARE TREATMENT

DEA STAY OUT ON MEDICAL PAIN CARE TREATMENT

You’re Within The Norms

Nov 25

REPORTED BY

youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT BS., MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CLINTON BATTLE, JR., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., IN THE SPIRIT OF GIOVAN MBEKI, RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

Becker’s ASC Review Logo
Judge sides with pain physician, orders CVS to resume filling his scripts

Laura Dyrda – Tuesday, August 17th, 2021

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Crestview Hills, Ky.-based Kendall Hansen, MD, won a temporary restraining order against CVS Pharmacy, which stopped filling prescriptions for his patients earlier this year.

Dr. Hansen, an interventional pain physician who prescribes controlled substances as part of his treatment regimens for some patients, was granted a temporary restraining order against CVS Pharmacy Aug. 11. The company is now required to fill prescriptions written by Dr. Hansen.

In June, CVS contacted Dr. Hansen with questions about his prescribing practices but did not express concerns about whether Dr. Hansen’s prescriptions were medically necessary. CVS then sent a letter to Dr. Hansen July 28 to say pharmacists in northern Kentucky would stop filling prescriptions for his patients.

Dr. Hansen sued CVS on Aug. 4, arguing the company’s refusal to fill his prescriptions would cost him patients and imply the prescriptions he wrote in the past were illegitimate or improper. Dr. Hansen said he has more than 250 patients who fill prescriptions at CVS locations.

In issuing the restraining order, U.S. District Judge William Bartelsman wrote Dr. Hansen was likely to succeed in his lawsuit alleging CVS Pharmacy interfered with his patient relationships by not filling prescriptions without evidence that Dr. Hansen had broken the law.

Latest articles on ASC News:

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Federal agents accuse Hansen of getting other doctors to prescribe him high doses of opioids. Those agents claim Hansen would write prescriptions for employees and instruct them to bring him the pills.

The indictment against Hansen lists 480 tramadol doses and 30 phentermine doses.

In a separate filing, federal agents accuse Fletcher of writing oxycodone hydrochloride prescriptions that were not for legitimate medical use.

The Kentucky Board of Medical Licensure restricted both Fletcher andHansen’s licenses Nov. 23, prohibiting them from prescribing controlled substances.

Each doctor had federal arraignments Dec. 1 in which they pleaded not guilty. Hansen wrote a statement to WCPO 9 saying the federal court decided he could continue to prescribe controlled medications pending the result of his case.

“We are worried about public safety and welfare if over 100 patients a day are forced to go into withdrawal and then feel the full effect of their pain and lose the ability to function because of their medically necessary pain diagnosis,” Hansen said in the statement. “We have over 3,000 patients, so this could result in a medical emergency and national news.”

Hansen said there are a few other local pain practices, but not enough to take on all of their patients. Hansen says Interventional Pain Specialists has been under investigation for about three years, and no charges have been filed against the business.

Outside the practice, one of Hansen’s patients, Jacqueline Fritsch, said, “When I came here, I could hardly walk, and that man has helped me tremendously. I can walk now.”

One of Fletcher’s patients, Jackie Carter, cried as she described the pain she is enduring since the federal indictment.

“On top of all the pain, I’m having withdrawal symptoms,” said Carter. “This is not right. There’s people that’s in extreme pain, myself included, and what he’s done is just not acceptable.”

Carter said she has had trouble finding other care.

LOW HANGING FRUIT

“I have tried, but I have been told by eight doctors this morning doctor’s offices say they will not touch Dr. Fletcher’s patients. They will not see them. They said to check with your primary physician,” said Carter.

She said her primary doctor does not prescribe controlled substances, an issue Hansen raised in his statement.

“IPS and the Specialty of Pain Management was asked to increase prescribing of opioids after primary care physicians were told to limit chronic prescribing,” Hansen said. “I have been in discussions with heads of St. Elizabeth Hospitals asking for help during our recent issue.”

Hansen filed a complaint in federal court in August against CVS Pharmacy. In it, he accuses pharmacists of refusing to fill his patients’ prescriptions.

WCPO 9 is still waiting for a response from Fletcher.

He faces three counts of Distribution of a Controlled Substance. Hansen faces one count of Conspiracy to Distribute Controlled Substance and two counts of Distribution of a Controlled Substance.

They are each scheduled to be back in court for pretrial conferences Jan. 26.

RELATED: Northern Kentucky doctor who illegally dispensed pills sentenced to decade-plus
RELATED: Former Kenton County Coroner pleads not guilty to illegally distributing opioids

Kings County Supreme Court
Assignment of Index Number
11/23/2022

WHEN YOUR PHARMACIST WITHHOLDS YOUR PAIN CARE: “I DON’T FEEL COMFORTABLE,”

1306.04(a) “CORRESPONDING RESPONSIBILITY DANGERS WHEN YOUR PHARMACIST WITHHOLDS YOUR PAIN CARE: “I DON’T FEEL COMFORTABLE,” THE STORY OF KATHERINE ROSENBURG-DOUGLAS A CHICAGO TRIBUNE REPORTER ‘WHO HAD BROKE-NED HER BACK’

You’re Within The Norms

Nov 24

UPDATED AND REPORTED BY

ORIGINAL JULY 15, 2021

youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT BS., MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CLINTON BATTLE, JR., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., IN THE SPIRIT OF GIOVAN MBEKI, RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

A REPUBLICATION OF MS KATHERINE ROSENBURG-DOUGLAS’S STORY AND THE DRUG INDUSTRIAL COMPLEX WHICH WITHHOLDS PAIN MEDICATION PRESCRIBED BY YOUR DOCTOR

A REPUBLICATION OF MS KATHERINE ROSENBURG-DOUGLAS’S STORY AND THE DRUG INDUSTRIAL COMPLEX WHICH WITHHOLDS PAIN MEDICATION PRESCRIBED BY YOUR DOCTOR
“…Condemn the opioid epidemic, sure…But remember those of us in chronic pain who need help.
KATHERINE ROSENBERG-DOUGLAS

BY

KATHERINE ROSENBERG-DOUGLAS

CHICAGO TRIBUNE |JUL 12, 2019 AT 7:34 PM

“I broke my back while Rollerblading when I was 21. After three surgeries beginning at age 30, I’ve recovered enough that I’ve gone on to what looks like a normal life. I’m a married mother of twin 4-year-olds, so I am relatively stressed, but fortunately, I’m otherwise relatively healthy.

I’m also on a fentanyl patch delivering slow and steady pain relief to keep me feeling like I can get out of bed, and morphine for breakthrough pain when life requires more of me than merely getting out of bed — and anyone who has ever had a 4-year-old knows each day is far more demanding than that. Just driving my kids to school or sitting for longer than 20 minutes at a time is a struggle.”
Chicago Tribune reporter Katherine Rosenberg-Douglas undergoes a spinal injection procedure on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has faced increasingly onerous regulations in managing her pain amid the opioid epidemic. (Erin Hooley / Chicago Tribune)

https://www.facebook.com/watch/?v=3708394616116679
Doctors don’t decide if you need it, pharmacists do!!!

Ms. Rosenburg-Douglas writes:

“Last month, I dropped off a prescription before I started work at 7 a.m. on a Sunday, and the pharmacist said she’d need to speak to the doctor so I probably wouldn’t get it until Monday. I had my doctor paged at 6:30 a.m. Agonizing hours passed before I called and pressed for the reason. She told me there were “great distances involved,” between my address, the doctor’s office, and where I was visiting my parents for the weekend — although they’re all about a 45-minute drive, pretty standard for Chicagoland.”

“It’s suspicious,” she said.

“I DON’T FEEL COMFORTABLE”

The previous month a pharmacist told me she wasn’t comfortable with the combination of fentanyl and morphine because, “It’s a lot of pain medicine.”

Joseph L. Webster MD SR., MD, MBA, FACP, BS. PHARMACY:

” It is not the purview nor is the pharmacist trained to ‘challenge the diagnosis of the physician and to do so verbally or otherwise with the patient. It erodes the ‘doctor-patient relationship and destroys the ‘confidence’ of the patient in his/her physician. At the very least it is ‘unethical’ and may very well be a HIPPA violation and beneath the standard of care as a pharmacist.”

“She filled the fentanyl patches but would not fill the morphine. When possible, I’ve used the same pharmacy chain for much of the past 10 years so there would be an easily accessible log of my prescription history, so I implored her to look. She said she had.”

“If anything were to happen to you, I would lose my license, not your doctor,” she told me. I mentioned that without the morphine I’d taken for so long, she was putting me in a more perilous situation than if she did. True, she admitted. “But I have the right to refuse to fill any prescription for any reason, and I choose not to fill this for you.” Then she gave me directions to a rival pharmacy chain’s store.”

THE PHARMD, “SECOND GUESSING PROVIDERS DIAGNOSES”

‘THE MOST DANGEROUS TYPE OF PHARMACIST’

AND THEIR FAILURE TO UNDERSTAND THE PATHOPHYSIOLOGY OF PAIN

Pain and pain management is a very complex issue. More often than not in chronic (non-acute) pain which is considered a disease, comorbidities need to be addressed. The “uncomfortable pharmacist,” has failed to develop a basic understanding of pain pathophysiology and neuroscience and the basic structures and function of the Nervous System which is a complex structure that coordinates voluntary and involuntary actions by transmitting signals to and from different parts of the body.

The truth is that overprescribing has no definition, is not a medical term, and has not been proven that substance exposure alters any aspect of the “opioid crisis.” In fact, patients on long-term opiate therapy for pain stabilization are the least likely to overdose on their medications.

The practice of the “uncomfortable pharmacist” in withholding treatment of a patient by altering or denying medications is both dangerous and unacceptable in the field of medicine; it has resulted in patients’ suicide.
Richard Lawhern PH.D.___
“Morphine Milligram Equivalent Daily Dose (MMEDD) is not a useful measure in defining limits on opioid dosage, and as such, it has been repudiated by the American Medical Association(AMA). Instead, its major utility is as a rough guide to the clinician in making a safe transition from one opioid to another.”

However, what makes these Pharmacists even more dangerous is their opinions and reasoning are based on the foundation of CDC’s flawed Unscientific Opioid prescribing Guidelines developed under unreliable data. Their maleficence has resulted directly in pain care patients’ suicides and the increased use of illicit counterfeit street drugs.

“PHARMD’s PHYSICIAN WANTA BE”

Exposing “The Uncomfortable Pharmacists”

Furthermore, pharmacists’ attitudes have their etiology in a belief that they have a corresponding responsibility which in fact requires them to operate within the field of medicine in giving a second opinion; thus undermining the diagnosis and treatment plan of the prescribing practitioner.

Its origins have further become grounded in positioning hospital medical politics, “power-hungry egos” to elevate the pharmacy profession out from images of just being in the basement of a hospital dispensing and compounding to a clinical role on the healthcare team.

In these cases, the pharmacist acts by using no materials to support their “uncomfortable foundation.”

The pharmacist does no physical examination on the patients.
The pharmacist reviews nor orders any lab work.
The pharmacist reviews nor orders additional radiographs and views no progress report.
The pharmacist further fails by entering nothing into writing as to the decision of how they determine the prescription(s) to be illegitimate and why they’ve interjected themselves into the practitioner-patient relationship by withholding or denying patients their medications.

“ The American Medical Association strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denial of legitimate medications”

JOSEPH L.WEBSTER, SR., MD, MBA, FACP, BS. PHARMACY:

The respective regulatory bodies, including the various “Boards” of Pharmacy, Medicine, Dentistry, Nursing, etc., clearly outline the ‘scope of practice’ for each of those disciplines.

The orderly flow of a prescription “from” the doctor to the patient – via the Pharmacist – clearly outlines where the ‘diagnosis’ has to come from. It is statutorily the purview of the pharmacist to ‘inspect and assure’ that the drug that is being given is safe and has no known incompatibilities with the patient and its holistic environment.

It is not the purview, nor is the pharmacist trained to ‘challenge the physician’s diagnosis and to do so verbally or otherwise with the patient. It erodes the ‘doctor-patient’ relationship and destroys the ‘confidence’ of the patient in his/her physician. At the very least it is ‘unethical’ and may very well be a HIPPA violation and beneath the standard of care as a pharmacist.

Any healthcare provider that is licensed to ‘prescribe’ is governed by the set of conditions and circumstances under which a prescription can be written.

Thus it is illegal to prescribe for a person that the prescriber has not conducted the ‘chain of authority that would qualify them to write a prescription: history and physical examination, formulation of a diagnosis, and discussing such with the patient as well as the proposed manner of treatment in a culturally sensitive and ethically appropriate manner; and provision of an opportunity for the patient to ‘question and discuss alternative forms of treatment; etc.

Once the provider has met all of the aforementioned and other ‘requirements to write a prescription, then and then ONLY should a healthcare practitioner write a prescription. Furthermore, as stated above, a pharmacist IS NOT AUTHORIZED TO WRITE A CONTROL PRESCRIPTIONS by any of the health regulatory boards.

It is my professional opinion that the pharmacist in question had ‘no reason and more importantly the pharmacist had ‘no power’ to question or interrogate each provider on ‘each prescription’ that is received as long as the ‘safety, efficacy and convenience’ of the medications being prescribed meet the standards of Medication Dispensing.

Any given medication can be and certainly will be given for multiple different diagnoses and it is not even feasible for the pharmacist to ‘contact and question’ each and every diagnosis.

The American Medical Association wrote on June 16, 2020:

While the AMA understands that the apparent goal of the Centers for Disease Control (CDC) Guideline was to reduce opioid prescribing, we believe the proper role of the CDC is to improve pain care. Therefore, it follows that a dedicated effort must be made to undo the damage from the misapplication of the CDC Opioid Guidelines.

We are concerned that such a careful approach to identifying the precise combination of pharmacologic options could be flagged on a prescription drug monitoring program as indications wrongly interpreted as so-called “doctor shopping” and cause the patient to be inappropriately questioned by a pharmacist. The AMA strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denials of legitimate medication.”

Josh Bloom, ACSH’s Director of Chemical and Pharmaceutical Science:

In today’s anti-opioid climate, a “one-size-fits-all” mindset has become the foundation of government-dictated medicine. And it’s awful medicine. For example, the deeply flawed policies enacted as law all over the country are based on the “one-size-fits-none” concept of morphine milligram equivalents (MME) – the maximum amount of an opioid medication that is permitted per patient per day.

https://www.cato.org/multimedia/cato-daily-podcast/follow-science-opioids

IN FACT, the CDC MME chart, the entire concept of morphine milligram equivalents may be convenient for bureaucrats. Still, because of differences in the absorption of different drugs into the bloodstream, half-life of different drugs, the impact of one or more other drugs on opioid levels, and large differences in the rate of metabolism caused by genetic factors are not only devoid of scientific utility but actually causes far more harm than help by creating “guidelines” that are based upon a false premise. When a policy is based on deeply flawed science, the policy itself will automatically be fatally flawed. It cannot be any other way.
Table 1. MME equivalents. Source: CDC

While MME values are touted as useful predictors of the total “opioid load” that a patient can receive, they are nothing of the sort. And MME-based policies don’t just fail because of differences in the size of patients; they fail for multiple reasons.

1. Flawed science yields meaningless results

Morphine is normalized to 1.0 and the conversion factor reflects the relative potency of other opioid drugs. So, if the daily MME – the maximum dose of a drug allowed – is 90 mg. This assumption could not be less accurate. Once we see the profound differences in the properties of the drugs and the difference between individuals who take them it becomes clear that not only is the CDC chart flawed, but the MME is little more than a random number.

2. Not all opioids are created equal, especially in the body

Anyone with even a passing knowledge of pharmacology would immediately be skeptical of data in the chart. Bioavailability. One of the many pharmacokinetic properties required to establish how a drug will fare within the body is called bioavailability – a critical determinant for whether a drug will be effective if taken orally.

3. Bioavailability is a measure of how well a pill will be absorbed in the gut and subsequently enter the bloodstream.

4. Half-life and metabolism

Although critical, bioavailability is far from the only measure of an oral drug’s effect on people or animals is primarily metabolized by two different cytochrome P450 enzymes called 3A4 and 2D6.

The difference in metabolizing enzymes itself is a substantial concern when comparing two different drugs, but it becomes even more so when other drugs are part of the picture. The only certainty is uncertainty

“NOT AT WALGREENS”

THE RED FLAG – Distance

The DEA has developed criminal elements of free commerce by criminalizing distance travel as an element of criminal conduct. Whereby a pharmacist is a licensed practitioner who has advanced knowledge of the chemical-physical properties of medications, mechanism of actions, their dosage forms design, will likely not refer to GOOGLE MAPS as an element of patient treatments.
OPE’RA, PARIS, lie-de-France, France September 4, 2017

More dangerously, as a result of the DEA’s aggressive policing of community pharmacies many are reluctant to fill any legitimate narcotic analgesic medication prescriptions for non-acute pain patients.
TRAUMATIZING THE AFFLICTED

In the exploring role and purpose of the DEA that acts as an unregulated medical agency policing the medical profession without legal standards and grounds.
GUN SHOT WOUND

The DEA Diversion Investigator claims in arbitrary reasoning; their actions are based on factors applied that “traveling long distances to fill prescriptions can be a red flag of abuse and diversion if a patient travels a significant distance to a particular pharmacy.
REBBECCA

Some patients are known to spend days on end looking for a pharmacy to fill their prescriptions to no avail. This has caused massive concerns in the chronic pain disease medical/dental community, where one of the most important goals of any therapy is continuing staple treatment without disruptions.

It is well understood amongst medical/dental practitioners when disruptions in therapy occur, many of the deleterious effects are likely to happen. For example, patients diagnosed with Sickle Cell Anemia are many times profiled as addicts, rather than as persons with a chronic disease condition needing treatment for pain.
BULLET WOUND WHERE RIGHT ELBOW WAS DESTROYED (PRONTO PHARMACY 05/18)

Other examples include persons who have survived traumatic accidents such as automobile accidents, gunshot wounds (civilian and military), notwithstanding leukemia, and other cancers.
CANCER OF LEG 9/29/17 PRONTO PHARMACY

Indeed, pain management becomes even much more difficult when anxiety and diminished mobility complicates the treatment plans.

Further, it is well understood, when both medical/dental practitioners and patients can locate a Pharmacy that will fill pain control prescriptions with dignity and respect, both parties will often share that information with others.
Pain you can’t see

Ms. Rosenburg-Douglas further wrote:

” I have a number of diagnoses. Failed back syndrome, a medical term that means just what it says and suggests surgery didn’t help. A “bone stimulator” was implanted during one surgery to encourage growth between pieces of cadaver bone and my own vertebrae, but too much bone grew in around my sciatic nerve, giving me sciatica, or a burning sensation from my rear down my left leg to my toes, which often are numb and tingling (I take another medication for nerve pain).
A monitor shows pain management specialist Dr. Richard Caner performing a spinal injection procedure on Chicago Tribune reporter Katherine Rosenberg-Douglas on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has needed opioids to control severe pain for more than a decade. (Erin Hooley / Chicago Tribune)

My left leg has so much atrophied muscle that it drags behind my right and I had a pronounced limp, but the fentanyl patch largely has eliminated that by providing more steady pain relief. I am disabled, but no longer outwardly appear so, which, along with my age, probably accounts for the daily dirty looks people shoot me when I park in handicapped spaces.
Chicago Tribune reporter Katherine Rosenberg-Douglas is helped to her ride from friend Courtney Holbrook with the help of medical assistant Mario Flores after undergoing a spinal injection procedure on July 2, 2019. The use of a fentanyl patch has helped to correct a pronounced limp. (Erin Hooley / Chicago Tribune)

I understand why police, politicians, and many doctors want to combat the opioid epidemic, but I’m tired of people throwing around that term and lumping me in with a group of drug abusers.

I support the spirit behind their efforts, but can’t support any more regulation on controlled substances. We have now overcorrected, and anyone who requires pain medicine is looked upon as a criminal.

It was once hard to imagine being in more pain than I am, but the current regulations added a new layer of suffering. Please remember opioids exist for a reason and don’t let it get any more difficult for those already in agony”

FOR NOW, YOU ARE WITHIN

Pt self advocating… with a little knowledge, facts and little Chutzpah pt gets their medically necessary meds

Hello Steve,

My name is xxxxxxxx  and I am on disability for several reasons. Bulging/burst discs in my back, both knees need to be replaced and I have severe depression and anxiety.
I live in Florida and I am having an issue with a pharmacist at the Winn Dixie pharmacy. I recently changed pain management doctors so I could go from paying $175 every month to the new doc being covered by my insurance 
The new doctor could see that my pain wasn’t being managed well and changed my medication. I weigh xxx lbs and cannot have knee surgery until I lose xx lbs. I tell you this because my weight contributes to the terrible pain I feel when walking. It feels like daggers being shoved into my knees.
The pharmacist refused to fill the new prescription because, in her opinion, going from 15mg Oxycontin 4x per day to 8mg Dilaudid 3x per day was too much of a jump in dosage. My doc sent in a new script for 4mg Dilaudid 3x per day and the pharmacist filled it.
Unfortunately, this dosage is not managing my pain. The affects of the Dilaudid only last 2-3 hours so I am bedridden most of the time. My doctor prescribed 15mg morphine extended release 1x per day to give the Dilaudid a boost. The pharmacist has refused to fill this prescription.
Is the pharmacist right in using her discretion or is she violating my rights under the ADA? If it is a violation, could you give me an idea of where in the ADA the law is stated?
Thank you so much! It’s a wonderful thing you’re doing!
With thanks,


My response to this poor patient:

https://globalrph.com/medcalcs/opioid-conversions-calc-original-single-agent/

This is a MME conversion program … that – AT BEST – creates CRUDE ESTIMATES AT BEST…  you can pull up the hyperlink above and there is 6 different warning foot notes on this page…

According to this  conversion prgm the 24 mg of Dilaudid ( Hydromorphone ) was – in theory – about 6% more than the 60 mg Oxcodone/day you were taking.  So the 12 mg/day of Dilaudid ( Hydromorphone) was actually  – in theory – about 50%  of  your Oxycodone 60 mg/day you were on previously.

Personally,  IF I was presented a Rx with what you were taking  60mg Oxycodone/day and what you were prescribed to replace that 24 mg Dilaudid/day…  a 6% increase for someone routinely taking that much opiates – NO BIG DEAL – at most I would have a conversation with the pt about the timing in how they were taking this new medication.

In my opinion, your doc would have to have given you abt Morphine  45mg- 60 mg/day to get you up to where you were. Besides causing you elevated pain, that pharmacist could possible be throwing you into withdrawal – which could be considered INTENTIONAL

Here is a “new” regulation that the FL board of pharmacy implemented in Dec 2015 – basically the BOP stated that a Pharmacist was not suppose to start looking for a reason NOT TO FILL when first presented a Rx to be filled.   https://floridaspharmacy.gov/latest-news/validate-pain-medication-prescriptions/  Unfortunately, I have not heard about the BOP taking any pharmacist to task over doing what this Winn Dixie pharmacist did to you.

One of the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy…  When all is said an done… this pharmacist appeared to have “bullied”  your doc to drop your pain management without any real clinical justification.

In my experience, the agency that is in charge of enforcing the ADA & Civil Rights Act is under the Presidential Cabinet Seat ( DOJ)… is also the same place where the DEA is also positioned and they have little/no interest in enforcing the ADA or Civil Rights Act.

IMO, that pharmacist is not as “smart” as she thinks she is… in regards to opiate rotation dosing.  Feel free to share this email with your prescriber or talk to the Pharmacist in charge at the pharmacy…  Your doc may want to call the pharmacy/pharmacist back up and tell them if they don’t want to honor his medication orders as written, he will file a complaint with the board of pharmacy and medical licensing board of attempting to practice medicine without a license. 

You might also wish to reach out to the VP of pharmacy services at Winn Dixie

Winn-Dixie Stores, Inc Corporate Office & Headquarters

5050 Edgewood Ct.JacksonvilleFL32254

Winn-Dixie Stores, Inc corporate phone number:

(904) 783-5000


Email I got back from the pt:

Steve, 

Thank you so much for the info! I spoke with the PIC today and she said she’d have no problem filling my prescriptions.
Reading your material gave me the courage to stand up for myself. I’m so grateful.

Billions in Opiate lawsuit settlement: It’s not going to magically end this crisis

Schools, Sheriffs, and Syringes: State Plans Vary for Spending $26B in Opioid Settlement Funds

https://khn.org/news/article/state-plans-opioid-settlement-funds/

A local group that advocates for people affected by the opioid epidemic has expressed similar concerns and is now suing the foundation for a lack of transparency, even though few decisions about funding priorities have been made yet.

The strife in Ohio highlights the tensions emerging nationwide as settlement funds start flowing. The funds come from a multitude of lawsuits, most notably a $26 billion settlement resulting from more than 3,000 cities, counties, and states suing manufacturer Johnson & Johnson and distributors McKesson, AmerisourceBergen, and Cardinal Health for their roles in the opioid crisis. Payments from that case began this summer and will continue for 18 years, setting up what public health experts and advocates are calling an unprecedented opportunity to make progress against an epidemic that has ravaged America for three decades.

But, they caution, each state seems to have its own approach to these funds, including different distributions between local and state governments and various processes for spending the money. With countless individuals and groups advocating for their share of the pie — from those dealing with addiction and their families to government agencies, nonprofits, health care systems, and more — the money’s impact could depend heavily on geography and politics.

“It sounds like a lot of money, but it’s going to a lot of places and going to be spread out over time,” said Sara Whaley, a researcher at Johns Hopkins Bloomberg School of Public Health who tracks state use of opioid funds. “It’s not going to magically end this crisis. But if it’s used well and used thoughtfully, there is an opportunity to make a real difference.”

And if not, it could be just another political boondoggle.

Avoiding the ‘Tobacco Nightmare’

The worst-case scenario, many say, is for the opioid settlement to end up like the tobacco master settlement of 1998.

States won $246 billion over 25 years, but less than 3% of the annual payouts are used for smoking prevention or cessation, according to the Campaign for Tobacco-Free Kids. Most has gone toward filling budget gaps, building roads, and subsidizing tobacco farmers.

But there are stronger protections in place for the opioid settlement dollars, said Christine Minhee, founder of a website that tracks the funds.

Jacqueline Lewis, son Shaun, and his 7-year-old daughter lived together in a family home in Columbus, Ohio, until this fall, when Shaun died of an overdose. (Maddie McGarvey for KHN)

The arrangement specifies that states must spend at least 70% of the money for opioid-related expenses in the coming years and includes a list of qualifying expenses, like expanding access to treatment and buying the overdose reversal medication naloxone. Fifteen percent of the funds can be used for administrative expenses or for governments to reimburse past opioid-related expenses. Only the remaining 15% is a free-for-all.

If states don’t meet those thresholds, they could face legal consequences and even see their future payouts reduced, Minhee said.

“The kind of tobacco nightmare stuff where only 3% of funds were spent on what they were meant for is legally and technically impossible,” she said. Though, she added, “a different nightmare is still possible.”

Experts tracking the funds say transparency around who receives the money and how those decisions are made is key to a successful and useful distribution of resources.

In Rhode Island, for instance, public comment is a regular part of opioid advisory committee hearings. In North Carolina and Colorado, online dashboards show how much money each locality is receiving and will track how it is spent.

But other states are struggling.

In Ohio, the document that creates a private foundation to oversee most of the state’s funds says that “the Foundation shall operate in a transparent manner” and that meetings and documents will be public. Yet the OneOhio Recovery Foundation has since said it is not subject to open-meetings law. It has adopted a policy that meetings can be closed if the board decides the content is “sensitive or confidential material that is not appropriate for the general public.”

The contradiction between the board’s actions and how it was conceived led Dennis Cauchon, president of Harm Reduction Ohio, which distributes naloxone across the state, to sue the foundation. He said he wants the public to have more say in how the funding is spent.

“The board members are in a closed loop, and they’re having a hard time learning what the needs are,” Cauchon said.

The 29-member board includes representatives of local regions, as well as appointees from the governor, state attorney general, and legislative leaders. Many are city- and county-level politicians, and one is the wife of a U.S. senator. They are not paid for this role.

Nathaniel Jordan, executive director of the nonprofit Columbus Kappa Foundation, which distributes naloxone to Black communities in Ohio, has raised concerns about the board’s lack of racial diversity. Since 2017, Black men have had the highest rate of drug overdose deaths in the state, he said, but only one board member is Black. “What gives?”

Kathryn Whittington, chair of the OneOhio Recovery Foundation, said the board is being “very transparent in what we are doing.” The public can attend meetings in person or online. Recordings of past meetings are posted online, along with the agenda, board packet, and policies discussed — including a draft of the diversity and inclusion policy the board is considering.

A “Stay the Course” card that Jacqueline Lewis painted for son Shaun hangs at home in Columbus, Ohio, on Oct. 18, 2022. (Maddie McGarvey for KHN)
Shaun Lewis showed his recovery coin in the room he shared with his daughter at home in Columbus, Ohio, on Oct. 18, 2022. (Maddie McGarvey for KHN)

People who want to provide input “can always reach out to me as the chair or any other board member,” said Whittington, who added that two of her children have struggled with addiction too. But the best option is to contact one of Ohio’s 19 regional boards, she said. Those groups can elevate local concerns to the foundation board.

“We are still at the very beginning,” Whittington emphasized. No money from the 18-year settlement has been spent yet. The board’s operational expenses — including a $10,000-per-month contract with a public relations firm — is being paid from $1 million from a previous opioid-related settlement.

But Lewis, the woman raising her granddaughter in Columbus, worries that the day for families to speak may never come.

“They keep saying it’s not ready, and before you know it, they’ll be handing out money and it’ll be too late,” she said.

Following the Money

Rhode Island is one of the states working fastest to distribute settlement dollars. Its Executive Office of Health and Human Services, which controls 80% of the funds and works with an opioid advisory committee, released a plan to use $20 million by July 2023.

Although the plan doesn’t specify funding for people raising grandchildren, it does allocate $900,000 to recovery supports, which will include community agencies that serve family members, the department said. The single largest allocation, $4 million, will go to school- and community-based mental health programs.

The investment that has sparked the most interest is $2 million for a supervised drug consumption site. Its location and opening date will be determined by organizations that respond to the state’s request for proposals, said Carrie Bridges Feliz, chair of the opioid settlement advisory committee. At a time when fentanyl, a synthetic opioid 50 times stronger than heroin, is infiltrating most street drugs and overdose rates are high, “we were anxious to make use of these funds.”

In contrast, the process of distributing settlement dollars in Louisiana has barely begun. State Attorney General Jeff Landry announced in July 2021 that Louisiana was expected to receive $325 million from the 18-year settlement but has not released any additional information. His office did not respond to repeated inquiries about the status of the funds.

The governor’s office and state health department said they could not answer specific questions about the funds and had not yet been contacted by the attorney general’s office, which negotiated the state’s settlement agreement. Multiple clinicians who treat substance use disorder and advocates who work with people who use drugs were similarly in the dark.

The state’s written plan says it will create a five-person task force to recommend how to spend the money. Kevin Cobb, president of the Louisiana Sheriffs’ Association, said the group had appointed its representative to the task force, but he didn’t know if other members had been selected or when they would meet.

Dennis Cauchon (left), president of Harm Reduction Ohio, has filed lawsuits against the OneOhio Recovery Foundation for a lack of transparency around its handling of the state’s opioid settlement funds. Nathaniel Jordan, who works to prevent overdose deaths among Black communities in Ohio, says the foundation board should reflect the diversity of those affected by the opioid crisis. (Maddie McGarvey for KHN)

One decision Louisiana has made so far is to give 20% of the settlement funds directly to sheriffs — a move that has made some people nervous.

“This plays into an increase in support for an authoritarian response to what are public health issues,” said Nadia Eskildsen, who has worked for syringe service programs and other such groups in New Orleans.

She worries that money will be funneled toward increasing arrests, rather than helping people find housing, work, or health care. Meanwhile, almost 1,400 Louisiana residents died of opioid-related causes last year.

K.P. Gibson, the Acadia Parish sheriff who will represent the sheriffs association on the state task force, said his focus is not on punishment, but on getting people into treatment. “My jail problem will resolve itself if we resolve the problem of opioid addiction,” he said.

Many health and policy experts say using settlement funds to pair mental health professionals with police officers or provide medications for opioid use disorder in prisons could reduce deaths.

States’ choices generally reflect a range of local priorities: While Louisiana has carved out funds for law enforcement, Maine is dedicating 3% of its statewide share for special education programs in schools, and Colorado has allocated 10% to addiction infrastructure, like workforce training, telehealth expansion, and transportation to treatment.

Maine requires that some funds be used for special education because school districts also sued the opioid companies, said state Attorney General Aaron Frey.

Patricia Hopkins is superintendent of a rural school district in Maine’s Kennebec County, which signed on to a lawsuit against opioid companies. She hopes the settlement funds will allow her to hire more social workers to help children whose families have been affected by the opioid crisis.(Elisha Morris)

Patricia Hopkins said she signed on to the lawsuit because she’s seen the impact of the opioid crisis on students over the past decade as superintendent of school district 11, a rural part of central Maine’s Kennebec County with 1,950 students.

A report compiled by her staff in 2019 showed nearly 4% of students have a parent dealing with addiction.

Sixty miles north, in rural Penobscot County, school district 19 social worker Meghan Baker said she knows two siblings who were home when first responders arrived to revive their parents with naloxone, and another set of siblings who lost their mother to an overdose.

Students who experience this trauma often become angry, act out at school, and find it difficult to trust adults. When Baker refers them to counseling services in the community, they encounter waitlists that run six months to a year.

“If we could hire more guidance counselors and social workers, at least we can help some of those kids during the school day,” she said.

It’s clear that many have high hopes for the billions of dollars in opioid settlement funds arriving over the next two decades. But they have questions too, because effectively using this large pot of money requires planning and forethought.

For people like Jacqueline Lewis in Ohio, whose family has lost so much to an epidemic too long ignored, progress feels slow.

As she tries to make do on Social Security, Lewis focuses on the positives: Her granddaughter is a happy child, and her older brother lives with them to help out. But the financial worries gnaw at her. And what if her own health falters before her granddaughter is an adult?

“I might be OK right now, but tomorrow, I never know,” she said.

Did Doctors Overtreating With Opioids Cause the Overdose Crisis? A Soho Forum Debate

 

The above graphic is from PROP’s website and list those involved with this organization. I finally had the opportunity to watch this debate/video and it was between Dr. Fugh-Berman,MD a member of  PROP  Physicians for Responsible Opioid Prescribing and a professor at Georgetown U Medical Center and Jeffrey Singer.MD a  practicing surgeon and part of  The American Council on Science and Health

According to the PROP website it is financially sponsored by Steve Rummler Hope Network

and the The American Council on Science and Health apparently is sponsored by contributions from the general public.

I don’t normally watch to such lengthy videos, but this one was diffidently  was worth my time.