I was looking around Indiana’s PDMP ( INSPECT ), which automatically links a Narxcare report…

Here is a copy of a “generic warning”  about a pt taking both a opiate & benzo –  and LOOK who the warn is from  CDC – I thought that the FDA was in charge of medications ?

Also on the Narxcare report they apparently have “developed ” a  LME ( Lorazepam mgs Equivalents)

this is just a guess on my part, but… suspect that there was similar amount of clinical studies/science behind developing that “equivalence system” as was put behind the MME system and according to this information … that would be NONE !

As this recent post on my blog explains    Was/is the CDC 2016 guidelines built on a “false foundation ” and created a covert genocide on a protect class of people ?

After a little more research … it would appear that the CDC in late 2020 added the word “PREVENTION” to the name of their agency – but did not stop using the initials CDC .d Amazing how large the scope of the agency could be changed with just the addition of a single word ?

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30 Days Left of Public Comment on CDC’s Draft Clinical Practice Guideline for Prescribing Opioids

The CDC draft Clinical Practice Guideline for Prescribing Opioids (update to the 2016 Guideline for Prescribing Opioids for Chronic Pain) has posted in the Federal Register and 30 days remain in the 60-day public comment period. Public comment provides valuable insight from the populations that we serve. Please note that the 60-day public comment period will end on April 11, 2022. CDC is committed to supporting safe and effective pain care options for patients. CDC’s National Center for Injury Prevention and Control (NCIPC) is in the process of updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. Both healthcare professionals and members of the public who experience acute or chronic pain have expressed interest in understanding the recommendations outlined in the draft updated Guideline, and CDC highly values public and partner engagement and feedback in this process. <Visit the Federal Register to provide your comments on the draft Guideline update> Please see our webpage detailing the process of updating the Guideline. Encourage people you know who have direct experience with the role of opioids in pain care and the importance of the patient-clinician relationship to visit the Federal Register, review the draft update to the Guideline, and add their perspectives to the Federal Register Notice.

Submit and Comment See below for instructions to submit a comment during the public comment period. More detailed instructions can also be found on the Federal Register Notice (FRN) webpage and in the FRN for this document. To locate the FRN and view the draft of the updated Guideline, you can either: Click on the direct link to the FRN in this email or Go to FederalRegister.gov and search for “CDC’s Guideline for Prescribing Opioids” To submit a comment to CDC, please view the methods outlined in the FRN under the “Addresses” heading and select which option you prefer: Electronic comments via Regulations.gov

Go to https://www.regulations.gov and search for “CDC Guideline for Prescribing Opioids” A comment button on the top left of the page will allow you to submit your comments via a webpage with step-by-step instructions

Mail

Directions for how to submit a comment through the mail are provided in the “Addresses” section of the FRN on FederalRegister.gov

To ask a question, click on the “For Further Information Contact” heading in the FRN for the agency official contact information. General information about the process to provide a public comment can be found at the following links: Federal Register: Reader Aids: Using FederalRegister.Gov Federal Register: Reader Aids: Videos & Tutorials

Help us spread the word about this opportunity for input through social media. Tweet or social media post: Everyone deserves safe, effective pain care. CDC’s draft updated Clinical Practice Guideline for Prescribing Opioids is open for public comment now through April 11, 2022. Please add your feedback on this important update: https://go.usa.gov/xtAW5  Tweet or social media post: Your voice matters. CDC is accepting public comment on the draft updated Guideline for Prescribing Opioids through April 11, 2022. Please share your perspectives and experiences with pain care today: http://go.usa.gov/xznWH

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Visit the new Process for Updating the Opioid Prescribing Guideline webpage

Are You or Others Interested in Future Information? Anyone who would like to receive information related to the work of the National Center for Injury Prevention and Control (NCIPC), specific to drug overdose prevention (including the response to the opioid overdose epidemic) as well as other drug overdose updates (e.g., pertaining to resources and tools), may sign up at www.cdc.gov/emailupdates and select topics of interest.   Subscription Topics: Injury, Violence, and Safety Subtopic: Drug Overdose News Thank you again for your interest in the Injury Center’s work. CDC values your continued partnership.

Visit us at: www.cdc.gov/drugoverdose

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Ron Chapman II wrote a succinct explanation of the Supreme Court hearing for the Doctors Xiulu Ruan, MD and Shakeel Kahn, MD in his blog. He has given me permission to share his blog post. But also, please go to his original blog as that will help his search engine ratings as well. Thank you, Ron, for allowing us to share.
Ron Chapman II’s Post:

The Supreme Court heard oral argument today in the most important healthcare case since 1975, Ruan v. United States . While we were hoping for a glimmer of justice, what we got was a dizzying lesson on grammar, parsing of words, and speed limit analogies. But Justice Gorsuch in his gentle, fatherly cross examination style attempted to bring the argument for petitioners back on track by showing the nonsensical and circular nature of the Government’s argument.

This issue before the Supreme Court is thoroughly addressed here and if you aren’t familiar go back and read that article first.

Before we get into the oral argument its important to understand the changes in the case prior to the parties taking the podium. The issue before the 11th Circuit was the failure to give a “good faith” instruction which essentially permitted the Government to convict Ruan under a strict liability standard. The 11th Circuit believed that if his conduct failed to comport with the objective requirements of the practice of medicine then he should be convicted. Petitioners argued that if he subjectively believed he was following objective standards then he should be acquitted. The Government, straying from the 11th Circuit’s opinion pivoted in their opening brief and said that the physician must make an “honest effort to comply” with the objective standard of practice. This is where the train left the tracks. As Ruan’s counsel pointedly argued – the Government’s argument is a malpractice standard gussied up as an objective standard. The Government pivoted so hard that their argument appeared to turn in the direction of the petitioner, arguing that a subjective “honest effort” is enough. But instead of seizing on that juicy opportunity the justices questions sped past the issues at the heart of the case and turned into a confusing digression into the statutory elements of the offense.

I’ll explain.
THE INTENT COMPONENT

21 U.S.C. 841(a) is a drug trafficking statute. It basically says that its unlawful to knowingly and intentionally distribute controlled substances. But an exception exists in the statute for licensed practitioners. Doctors, pharmacists, and other prescribers and dispensers are exempt from the statute as long as their conduct is “for a legitimate medical purpose in the course of professional practice”. In order to address whether the “good faith” of a physician is relevant the court needed to answer a threshold question and that is whether the intent requirement of the statute applies to the distribution or the exception. Thus, the question is: Does the government need to prove that the doctor knowingly and intentionally distributed drugs or does the government have to prove that the doctor knowingly and intentionally prescribed “outside the course of professional practice and for other than a legitimate medical purpose”. If the government needs to prove only that a physician intended to prescribe drugs then the only doctor who escapes this element is one who prescribes in a coma – as Ruan’s counsel pointed out.

And so the court debated, for some time, whether the intent of the statute was to incorporate the prescriber’s exception as an element of the offense or an affirmative defense to the crime. If its an element, the the intent component must apply to the exception if its not then the intent component only applies to the distribution. Justice Alito seemed to think that the intent element is only related to the distribution and Gorsuch seemed to think that its related to the prescriber’s exception. The other justices didn’t offer much of a position but it seems that Breyer and Alito favor applying it to the distribution because failure to do so creates a statute with two separate intent requirements – one for prescribers and a separate for the general public. Breyer and Alito likely believe that such a reading frustrates the intent of congress in creating the statute.
ONE GLARING OMISSION

But in all of the heated debate surrounding the statutory text of the Controlled Substances Act, the Court and the parties missed the most important issue in the case, and all physician prosecutions. Both the Government and Petitioners conceded in their briefs that the standard applied in such cases is an objective standard of practice- which is incorrect. Both United States v. Moore and Gonzalez v. Oregon clearly state that the Federal Government lacks authority to regulate the practice of medicine. The Government only has authority to punish physicians who act so flagrantly that their conduct can be seen as “drug pushing”. And so, the Government’s proof that a physician’s conduct departed from some sort of “objective standard of care” amounts to mere malpractice and something for State Boards to consider – an issue hinted at in Justice Thomas’s final question. Petitioners should have taken the position that the standard of care is relevant in physician prosecutions only to show the jury the reasonableness of the physician’s conduct but in order for the government to fully satisfy the elements of 841(a) they must prove that a physician’s conduct departed so far from the practice of medicine that they ceased practicing medicine at all.

For more on that point read my article “7 Dirty Words”.

Instead of arguing this federalist argument, the parties were landlocked by the fact that the court granted Cert on the “good faith” issue which necessarily requires an argument regarding the intent elements instead of elevating above this crucial digression and discussing the authority of the Controlled Substance Act to regulate the practice of medicine generally.

Tying an objective standard of care to the elements of an 841(a) violation is dangerous because (1) there is no consensus on what that standard actually is in the medical community, (2) it requires juries to grapple with complex and ever changing medical topics, (3) it allows the government and DEA to drive the standards of practice through CDC guidelines, “red flags”, DEA administrative decisions, and other unpromulgated guidance documents. This is dangerous because either subjectively or objectively the parties have permitted the government to take the position that violation of an invisible and ad hoc standard is sufficient for conviction in the first place.
PREDICTION OF THE COURT’S DECISION IN RUAN V. UNITED STATES

Predicting the outcome of a pending supreme court case is a bit like predicting the weather 30 days out – it ignores the dynamic interplay of the politics of the court. But I’ll take a stab. The Government abandoned the 11th Circuit’s rationale and the Court has no choice but to reverse the 11th Circuit and permit a good faith instruction or at the very minimum a proper instruction on the intent component of an 841(a) violation. It seems that at least five justices agreed with the fact that the intent requirement relates to the prescribers exception: Barrett, Gorsuch, Kavanaugh, Thomas, and Roberts. I think there are enough votes for reversal. But the tougher question is what relief, if any, can be afforded to doctors in the future given that both sides seemed to agree that an objective standard of practice is the standard in interpreting the phrase “legitimate medical purpose”. Kavanaugh seems to take the position that the statute is vague in the first place and may offer a concurring opinion and discuss vagueness unless he can pull the other four in his direction. But I don’t think he will be successful because of the politics of the Court. Determining that 841(a) is vague as applied to physicians will disrupt the balance of justice and require reversal of a lot, actually a ton, of convictions. And one thing we know about the Supreme Court is that it doesn’t favor such sweeping changes. Now this problem was set up by the Court in the first place in failing to address the statutory text since it was first enacted. Since 1975 we have been left without the voice of the court on this statute allowing the circuits to take differing interpretations and circuit splits as they grapple with the statutory text that was most likely written by a congressional staffer in 1970. But I do expect at least some comment on vagueness.

In sum, I expect Ruan and Khan to get some sort of relief from this decision because the jury instructions in their case mis-applied the intent requirement of the statute and made drug trafficking a strict liability offense (like speeding) as applied to physicians. But I don’t expect a sweeping change here, I expect a tailored attack on the 11th Circuit’s reasoning and I expect that the Circuit Courts will pigeonhole the Supreme Court’s decision to prevent its broad application to all physicians convicted under the statute.

There is some good news, potentially, on the horizon though. The Court has held the case of Naum v. United States pending the outcome in Ruan. This is a case where the federalism argument is very much alive. Its a case I have personally handled and if Cert is granted I will be arguing before the Supreme Court. We don’t know why Naum was held by the court but its likely because the Court didn’t want to address the federalism argument until it first decided the more minor issue of good faith and its application to the statutory text.

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long term under/untreated pain, can cause Addison’s disease. you can click on the hyperlink below to go to the article and see details under each ‘”symptom” but the very last because a Addisonian Crisis can be life threatening and you have experienced some or many of the symptoms and you are a chronic pain pts that has had their pain meds reduced or eliminated some time ago and you have been ignoring some/many of these symptoms. Perhaps once you get to the description of a Addisonian Crisis… it might be time to see a endocrinologist for a group of blood or diagnostic urine tests.

12 Addison’s Disease Symptoms You Shouldn’t Overlook

https://veryhealthy.life/12-addisons-disease-symptoms-you-shouldnt-overlook/

1. Feeling Tired All the Time

2. Decreased Appetite and Weight Loss

3. Low Blood Sugar

4. Low Blood Pressure

5. Nausea, Vomiting or Diarrhea

6. Pain in the Joints and Muscles

7. Irritability and Mood Swings

8. Abdominal Cramping

9. Depression and Suicidal Thoughts

10. Salt Cravings

11. Hair-Loss

12. Addisonian Crisis

This term describes the biological state where the body experiences complete adrenal fatigue. An Addisonian crisis can be a life-threatening event requiring immediate medical attention. Adrenal fatigue can present sudden symptoms such as shaking, anxiety, and dizziness. 

Addisonian crisis is the final stage of Addison’s disease; you should do all you can to avoid falling into this hormonal state. People living with Addison’s that experience frequent Addisonian crisis are at risk of developing other serious illnesses and diseases.

The best course of action to take in avoiding an Addisonian crisis is to visit your doctor for a hydrocortisone shot. The injection will be administered in the upper area of the buttocks and provides immediate relief from all symptoms.

Those individuals living with the advanced stages of Addison’s disease may need to keep an emergency hydrocortisone shot available in a travel medical kit. A medical professional will show you how to administer the intramuscular injection by yourself safely.

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Nothing is of any importance in this piece to the community – EXCEPT the sentence that I have highlighted in RED

A cautionary tale from DEA’s plan to return to the office

https://federalnewsnetwork.com/mike-causey-federal-report/2022/03/a-cautionary-tale-from-deas-plan-to-return-to-the-office/

Let the Drug Enforcement Administration be the first of what could be many cautionary tales across government.

DEA is requiring its employees no matter the job to come into the office at least three days a week. A recent memo from DEA division heads, as directed by Administrator Anne Milgram, requires employees to come into the office on Mondays and Thursdays, and one other day of their choosing. And if you are working an alternative work schedule — four 10-hour days or nine 9-hour days — telework is not an option.

DEA is moving from maximum telework or remote work to one of the most restrictive policies across government. DEA is expecting employees back in the office starting March 21, Milgram wrote in a memo in February.

While few would argue Milgram, who is rumored not to support telework and wanted to reduce it to one day a week but was talked out of it, should be able to run her agency as she sees fit.

But in making the decision, she is potentially creating a “have and have nots” situation across the Justice Department that very likely could see many see employees look for greener pastures inside DoJ or with other agencies.

DEA refused multiple requests for comments over a three-week period about its new telework policy.

“The feeling is DEA management doesn’t like telework and claim the agency is one that has to do work in person,” said one employee who requested anonymity for fear of retribution for talking to the press. “But this is just not the case for most people. There are a high percentage of DEA employees who are not in the office.”

And for most of the last two years, that has been the case for DEA and many other agencies.

Justice offers more flexibility

Milgram’s decision also creates tension with the Justice Department leadership. DoJ’s Management Division sent out a memo in late March promoting maximum telework options as the agency employees return to the office.

The memo builds on what the White House and the Office of Personnel Management have been promoting too — maximum flexibilities for continued remote work.

Lisa Monaco, the deputy attorney general, wrote to employees in late February that the agency is “closely monitoring CDC and OMB guidelines” and their reentry plans are based on science.

Monaco said she was “happy to announce in light of declining COVID infections” and employee vaccinations that the agency is shifting away from maximum telework and beginning in March will bring employees back to the office.

Monaco said this “does not mean returning to pre-pandemic operations. Rather each component is finalizing updated policies to meet unique operational needs which contain increased flexibilities including increase telework where practicable.”

Yes, Monaco gave the usual out for component leadership to “meet their unique operational needs,” — she is a lawyer after all — but the real crux of the sentence is not returning to pre-pandemic operations.

Over the last two years, the telework naysayers across government have been proven wrong, and the Biden administration is recognizing that remote work options don’t just need to continue but are an essential piece of creating a healthy and productive federal workforce.

Two lessons to heed from DEA

The cautionary tale from DEA is two-fold.

First, employees are receiving mixed messages and that are both confusing and disheartening. The White House and Justice headquarters are saying “telework is important and is a key tool in the personnel tool box.”

But the DEA isn’t following this lead and telling employees, “nope, the last two years are meaningless and you need to be here so we can see what you are doing and making sure you aren’t wasting time.”

So if you are a DEA employee in finance or IT or procurement and now you are required to spend an hour commuting and money on metro or ride share but you are seeing employees at the FBI or the Bureau of Alcohol, Tobacco, Firearms and Explosives who have similar roles as yours working from home four days a week, maybe it’s time to look for a new job?

“Whether it’s from the White House or the attorney general, they are giving directives to allow for more telework because it worked. It was better for retention and morale,” the source said. “Yes, you have to look at the nature of the jobs, but generally speaking we as government should be looking toward more telework and that is the message from the White House. But if you allow an agency head who doesn’t like telework to say it’s not good for their agency mission, then it’s creating confusion.”

One DEA employee who messaged Federal News Network privately summed it up this way:

“You ask about DEA’s plan, it stinks. Our upper management learned nothing about our telework capabilities. The plan is worse than before COVID. They preach they want a home work balanced workforce, but there cookie cutter plan is nothing close to a balance. What does having alternative work schedule and telework have to do with each other? Do they not realize we work additional hours to make up for that one day pay? That we used to schedule doctor’s appointments etc., so we don’t use additional leave during work days? I’m a manager of a small staff that is also very upset about the plan, I fear I will lose my talented non-core employees to other agencies that have a better grasp until telework as well as I fear we will not be able to bring on board the best candidates due to our policy.”

Governmentwide standards needed

The second part of the tale is the Office of Management and Budget and/or the Office of Personnel Management should consider strongly encouraging, even mandating, some sort of minimum baseline for telework, particularly for positions that are not classified and mostly back office type like human resources, procurement and the like.

This way there is consistency across job areas, and telework support doesn’t create yet another battlefield for hard-to-find people with a specific skillset.

OMB and OPM also could require agencies, like DEA, to make a business case and explain to employees why they need to be in the office more than one or two days a week.

This way agencies leaders have a starting point and then can explain in business terms to their employees about why returning to the office is important — beyond the collaboration and coordination platitudes that we too often hear.

After two years of successfully working remotely, DEA Administrator Milgram, and really any agency leader that is requiring certain employees to return to the office, owes their employees the courtesy of an explanation.

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Businesshala News Exclusive | CVS Ousts Executives After Internal Probe, Vows to Overhaul How It Handles Sexual-Harassment Complaints

https://businesshala.com/businesshala-news-exclusive-cvs-ousts-executives-after-internal-probe-vows-to-overhaul-how-it-handles-sexual-harassment-complaints/

CEO Karen Lynch tells staff she will change process after investigation into employee complaints against a regional manager

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My understanding is that Walgreens allows their pharmacists to “black ball” a pt in their pharmacy system and it applies to all some odd 9000 stores and that the only person that can take the black ball off is the person that put it on.  Of course, as I normally do, I recommended that this pt find a independent pharmacy …shared this link  https://ncpa.org/pharmacy-locator   — where she would be dealing with the pharmacist/owner and they tend to be a whole lot less judgemental and staff turn over is very little… so they know the pt and the pt knows the staff.  It is unfortunately that all these so called PharmD “medication experts” don’t know/understand that acute pain is different than chronic pain and that a chronic pain pt already taking a opiate will not need additional opiates to deal with the acute pain…  Most chronic pain pts… the opiates that they are on… don’t properly manage their existing pain on most days.

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https://www.nbcsandiego.com/news/investigations/national-investigations/harmful-deadly-pharmacy-errors-persist-during-pandemic-ca-complaints-allege/2890636/

Data obtained by the Investigative Unit shows at least 557 complaints of pharmacy medication errors harming California patients during the pandemic. Industry insiders say the real number may be far higher because pharmacies are generally not required to report mistakes to regulators.

Former Rite Aid pharmacy technician Priscila Sotelo says she quit her job in Union City during the pandemic because she was burned out and felt the increased workload put patients in danger.

“One time our pharmacist gave the wrong narcotic,” she told the Investigative Unit. “The line [of customers] was like 10 to 15 people at a time … everyone was panicking.”

Rite Aid told NBC Bay Area – like other big chain pharmacies – the company tracks medication errors internally and does not have information supporting Sotelo’s claim. Regulators are limited in their abilities to monitor medication errors though because pharmacies are generally not required to report the mistakes to state or federal regulatory agencies.

However, in response to national concerns about pharmacy workforce issues during the pandemic, the California State Board of Pharmacy released data in January saying it initiated 367 investigations after receiving complaints “indicating patient harm” for fiscal year 2020/21. It received 190 in the first six months of this fiscal year.

The Board said the reported medication errors varied in severity and included “serious patient harm and death.”

During that January board meeting, state regulators also discussed a workforce survey it approved last year. More than four thousand California pharmacists participated in the survey, which showed:  

• 91% of California chain pharmacists reported not having enough staffing to ensure adequate patient care, compared to 37% of independent pharmacists.
• 11% of California chain pharmacists reported medication errors are not documented appropriately, compared to 4% of independent pharmacists.

“Oh, [mistakes were] regular. It was on a daily basis,” said Clint Hopkins, who now runs his own independent pharmacy in Sacramento but worked in various chains as a pharmacist for eight years. He says he saw frequent mistakes caused by pharmacy workers trying to fulfill profit-driving prescription quotas set by big chain companies, like CVS, Walgreens and Rite Aid.

According to the state’s workforce survey, 90% of chain pharmacy workers said their worksite has a work queue monitoring waiting time for prescriptions, compared to 33% of independent pharmacy workers.

“When I first started working at Walgreens, they had … the little dials on the screen and you could see when you were on the phone too long or too many calls where coming in. It would turn red. It would turn yellow … You had to keep those green, right? The numbers had to be low or everyone was [panicking],” Hopkins said.

One small portion of a Walgreens monitor shared on this Facebook page shows a backlog of more than 2000 prescriptions still waiting pharmacist verification.

The Investigative Unit spoke with pharmacists who believe such a big backlog significantly increases the chances of medication errors at that undisclosed store. NBC Bay Area showed Walgreens the image which has been widely shared on social media but the company had no comment.

Legislation that went into effect last January – Senate Bill No. 362 – now prohibits companies from establishing potentially dangerous quotas for pharmacy workers in California. It’s a practice that requires employees to fill a certain number of prescriptions over a specific period of time. The California Pharmacists Association, a backer of the bill, says the law’s success relies on companies implementing the rules themselves; and one of the only ways regulators will know about possible violations will be if employees report them.

“I don’t think that it’s going to happen,” Dr. Hopkins said. “They’re afraid of the repercussions of reporting their company.”

Despite multiple requests, no one from the California State Board of Pharmacy or CVS, Walgreens and Rite Aid agreed to be interviewed about workload and mistake claims. Rite Aid told the Investigative Unit off-camera its labor model is based on work volume, which is why it tracks prescriptions.

Walgreens and CVS sent statements saying their metrics are not individual-based, rather a way for the companies to ensure appropriate levels of staffing at each pharmacy.

In November, Rite Aid made a company-wide decision to close most of its pharmacies one hour earlier Monday-Friday to allow workers to catch up on work, but that was temporary. 

How to Report Complaints to State Regulators

Although Senate Bill 362 was implemented in January, the California State Board of Pharmacy is still in the process of creating a SenateBill 362-specific complaint process for pharmacists and technicians.

In the meantime, both patients and pharmacy workers are encouraged to report medication errors and Senate Bill 362 violations by clicking this link or following these steps:

• Go to the Board of Pharmacy website
• Click Consumers
• Click Consumer Protection and Enforcement
• Click File a Complaint

This complaint form is for anyone to use, according to the California Pharmacists Association.

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