Did anyone notice this with the revised CDC opiate dosing guidelines ?

Posted on February 11, 2022 by Pharmaciststeve

CDC Clinical Practice Guideline for Prescribing Opioids–United States, 2022

The update process uses multiple key sources of input.

The 2016 Guideline was developed using the best available scientific evidence and followed a rigorous scientific process. The update to the Guideline is following a similar process and includes several opportunities for community and partner engagement. CDC highly values public engagement and has ensured there are multiple opportunities to hear from and incorporate feedback from patients with pain, caregivers, clinicians, and partners.

As I remember, there was no published proposed 2016 guidelines, the CDC attempted to keep all participants anonymous and there was NO PUBLIC COMMENT PERIOD. The people listed as involved with this revision are all most involved with addiction, substance abuse and overdoses.

the above is a direct quote from https://www.cdc.gov/opioids/guideline-update/index.html

This is on the first page of the revised CDC opiate dosing guidelines…

Wasn’t it Dr Chou on the first committee for the 2016 guidelines and AFTER THE FACT – admitted that he had conflict of interest ?

Here is where he is employed and the description of what they do:

https://www.ohsu.edu/evidence-based-practice-center/about

About Us

The Pacific Northwest Evidence-based Practice Center (EPC) conducts systematic reviews of health care topics for federal and state agencies, professional associations, and foundations. These reviews report the evidence from clinical research studies and the quality of that evidence for use by clinicians, employers, policymakers, researchers, and others in making decisions about the provision of health care services and health research. The reports may be used by public-and private-sector organizations to assist in improving the quality of health care, informing the development of clinical practice guidelines, and informing reimbursement and coverage policies. The Pacific Northwest EPC also participates in research on systematic review methods.

The EPC at Oregon Health & Science University was founded in 1997 under the directorship of Mark Helfand, MD, MPH, with funding from the Agency for Healthcare Research and Quality (AHRQ). Now under the leadership of Roger Chou, MD, the Pacific Northwest EPC is a collaboration of Oregon Health & Science University in Portland, Oregon, the University of Washington in Seattle, Washington, and Aggregate Analytics, Inc. in Fircrest, Washington. The EPC has received funding from AHRQ, the Drug Effectiveness Review Project, the National Institutes of Health, the Centers for Disease Control and Prevention, and various professional associations and foundations. The EPC at OHSU was previously known as the Oregon EPC.

Pacific Northwest EPC investigators come from a wide variety of disciplines within the partner institutions. Investigators with the EPC have a particular interest in diagnostic technology assessment, prevention, comparative effectiveness, evidence-based informatics, and health services research. In the past, faculty affiliated with the EPC have investigated a wide range of topics, including hepatitis, pressure ulcers, traumatic brain injury, pain management, drug effectiveness, cancer screening and treatment, HIV infection screening and prevention, telehealth, public reporting, menopausal symptoms, osteoporosis, vaginal birth after cesarean section, field triage of trauma, mental health, health equity, and substance use disorders.

 


CDC Clinical Practice Guideline for Prescribing Opioids–United States, 20221

Prepared by


Debbie Dowell, MD, MPH

https://www.cdc.gov/injury/pressroom/fullbios_subjectmatterexperts/bio_DebbieDowell.html

Chief Medical Officer, CDC Coronavirus Disease-2019 Response

Chief Clinical Research Officer, Division of Overdose Prevention, NCIPC

 

Areas of Expertise

  • Opioid overdose prevention
  • Opioid prescribing

Debbie Dowell, MD, MPH, is the chief medical officer for CDC’s COVID-19 Response and chief clinical research officer for CDC’s Division of Overdose Prevention at CDC’s Injury Center. She has served in various roles in CDC’s COVID-19 Response since February 2020, including deputy chief medical officer, chief medical/science officer, and associate editor of CDC’s COVID-19 Science Update.

Dr. Dowell completed her residency and chief residency in primary care internal medicine at Bellevue Hospital Center and the NYU School of Medicine, where she joined the faculty as a clinical assistant professor. She is board certified in internal medicine and served as an attending physician, providing care and supervising residents at a community health center in New York City. She currently volunteers at a community-based clinic, providing primary care for uninsured individuals in Georgia.

Previously, as chief medical officer for CDC’s Injury Center, Dr. Dowell led development of the CDC strategy to prevent opioid overdoses. She also served as advisor to New York City’s health commissioner. She has conducted research on quality and safety in medical care, the effects of clinical guidelines, and the effectiveness of interventions to prevent opioid overdose.

She received BA and MD degrees from Columbia University and an MPH degree from the Johns Hopkins Bloomberg School of Public Health. She is also a graduate of CDC’s Epidemic Intelligence Service (EIS).


Kathleen R. Ragan, MSPH

Centers for Disease Control and Prevention | CDC · Division of Overdose Prevention
MSPH, CHES
Kathleen is a Health Scientist in the Centers for Disease Control and Prevention’s Division of Overdose Prevention. Prior to working with CDC’s Division of Cancer Prevention and Control (2013-2018), Kathleen served as Director of Community Health for Susan G. Komen Central Georgia and as the Southeastern Community Health Educator for Native American Cancer Initiatives, Inc. She received her BS in Health Education from Georgia College and State University and her MSPH in Global Epidemiology from Emory University. Kathleen is also an experienced Certified Health Education Specialist and is passionate about working to address health disparities in underserved and rural populations.

Christopher M. Jones, PharmD, DrPH

Christopher M. Jones, PharmD, DrPH, MPH. Deputy Director National Center for Injury Prevention and Control, Centers for Disease Control and Prevention Member, Rx Drug Abuse & Heroin Summit Advisory Board. Christopher M. Jones, PharmD, DrPH, MPH CAPT, US Public Health Service Deputy Director, CDC Injury Center Areas of Expertise Substance use and overdose prevention Suicide prevention ACEs …

Grant T. Baldwin, PhD, MPH

Division of Overdose Prevention CDC Injury Center
Director
Dr. Grant Baldwin is the Director of the newly created Division of Overdose Prevention at CDC National Center for Injury Prevention and Control.


Roger Chou, MD

Division of Overdose Prevention, National Center for Injury Prevention and Control, CDC, Atlanta, Georgia

Office of the Director, National Center for Injury Prevention and Control, CDC Atlanta, Georgia

Pacific Northwest Evidence–based Practice Center and Oregon Health & Science University, Portland, Oregon

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health ‘Somebody is gonna die’: Medi-Cal patients struggle to fill prescriptions

Posted on February 10, 2022 by Pharmaciststeve

health ‘Somebody is gonna die’: Medi-Cal patients struggle to fill prescriptions

https://insurancenewsnet.com/oarticle/healthsomebody-is-gonna-die-medi-cal-patients-struggle-to-fill-prescriptions
SACRAMENTO >> A month into its debut, California’s new Medicaid prescription drug program is riddled with problems, leaving thousands of patients without medications — often after languishing on hold for up to eight hours on call center phone lines.

On Jan. 1, the state handed control of its Medicaid drug program, known as Medi-Cal Rx, to Magellan Health, which is administering prescription drug coverage for California’s 14 million Medicaid patients, most of whom previously got their medications from about two dozen managed-care plans.

But Magellan has tripped up implementation. It didn’t anticipate that calls to its help center would take so long, and a large number of its call center workers have been sickened during the omicron surge — with 100 of 220 absent during the first two weeks of January, state officials said. Magellan also didn’t get some data it needed from managed-care plans.

This has left Californians from Redding to Oceanside without their medications for days, sometimes weeks.

“We’ve had many, many patients who are sort of in this limbo,” said Dr. James Schultz, chief medical officer of Neighborhood Healthcare, which operates 17 clinics in Riverside and San Diego counties.

“Somebody is gonna die if they haven’t already,” added Schultz, who said some of his clinics’ patients have experienced delays getting life-saving medications such as antibiotics or those used to prevent seizures and blood clots. “That’s why we’re fighting so hard.”

Officials from the California Department of Health Care Services, which administers Medi-Cal, California’s Medicaid program for low-income people, called the problems “unacceptable.” The department and Magellan Health are scrambling to find missing patient data, fix improper claim denials, add call center staffers, and provide pharmacists with codes to override prescription denials.

Handing over Medi-Cal’s drug program to a single pharmacy benefit manager is one of Gov. Gavin Newsom’s big health care initiatives. His administration estimates it will save the state $414 million in the 2022-23 budget year alone, in part by getting bigger discounts on drugs than the managed-care insurance plans did.

But the massive transfer has been rocky for many providers, pharmacists, and patients, especially patients who use medications their doctors consider medically necessary but require prior authorizations from Medi-Cal Rx and are generally not on the state’s approved drug list. Magellan has received more than 95,000 prior authorization requests since it took over, state officials said.

In the months leading up to the switch, patients and doctors were told all their medications would be grandfathered into the new system for 180 days, but that hasn’t always been the case.

Marilyn Bloomer of Oceanside had gone nearly a week without a specialty histamine prescription that she takes to regulate an overactive allergic response in her body, a condition known as mast cell activation syndrome, because her pharmacist and Magellan said it was no longer covered. When she finally reached someone at the Magellan call center last week — six hours after she placed the call — a supervisor gave her a code the pharmacist could use to override the denial.

But the pharmacy wouldn’t accept it.

On Monday, Bloomer’s health plan secured an emergency five-day supply for her, but she doesn’t know what will happen when it runs out. Without the medication, called ketotifen, Bloomer gets bright red, patchy hives all over her face.

“I’m getting the runaround, and I’m getting confused,” said Bloomer, 57, who said her face had been beginning to swell. “It’s beyond frustrating.”

State officials said Magellan representatives had answered more than 81,000 calls at the 24-hour, 7-day-a-week call center as of Feb. 1 and paid 11 million prescription claims totaling approximately $1.3 billion as of Feb. 4.

“As we sit here, clearly five weeks into operations, Magellan, our contractor, has really struggled with some service operations,” Jacey Cooper, the state’s Medicaid director, told lawmakers at an Assembly budget subcommittee hearing Monday.

She said that the Department of Health Care Services is holding daily meetings with Magellan to discuss its management of the program and that the state has provided staffers to help answer calls at the Medi-Cal Rx call center. The immediate goal, Cooper added, is to ensure medications that require prior authorization are approved within 24 hours. In the meantime, she said, the state has given pharmacies the go-ahead to fill emergency prescriptions for up to two weeks. It also has removed prior authorization requirements for some medications.

Magellan referred media questions to the Department of Health Care Services.

After the hearing, Assembly member Joaquin Arambula (D-Fresno), who chairs the Assembly budget subcommittee that oversees Medi-Cal, said he is satisfied with the administration’s plan. “I believe there’s a real path forward to implementing the system successfully,” he told KHN.

Sharon Ng, pharmacy director at the Venice Family Clinic, isn’t as optimistic. Even though state officials say they have given pharmacies authorization to use override codes and fill temporary emergency prescriptions, prescriptions continue to be denied.

“It’s just chaos,” Ng said. “We just kept getting rejections. It’s been so frustrating because the rejection doesn’t tell you what’s wrong. And then if you finally go through their lines, they don’t help you either. They’re just guessing.”

What Magellan needs, she added, is a dedicated hotline for pharmacists — like the managed-care plans had — so they don’t have to compete with Medi-Cal patients.

Patients and legal advocates say they are confounded by the chaos because both the state and Magellan had plenty of time to prepare for the rollout, since the program was delayed by nearly a year after the health care company Centene announced plans to acquire Magellan.

Medi-Cal Rx finally launched Jan. 1 after state officials ruled in December that Magellan could independently administer the Medi-Cal drug benefit without any conflict of interest with its new owner.

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Rite Aid District Manager: gets involved when Pharmacist is playing games with a pt’s C-II Rx

Posted on February 10, 2022 by Pharmaciststeve

I am writing to you because I found your website and you had very good information on there, plus your email. You sound like an awesome advocate for someone like me. I have attached the email that I am sending to RiteAid leadership, so that you can see the issue.

I am writing regarding an incident I had with the Pharmacist at the RiteAid  in MD.

Last Thursday, I ordered my rx from my provider as usual and received a notice from RiteAid that it was too early to refill and would be refilled Friday 2/4. By 2pm I had not heard anything regarding my refill, so decided to head to the RiteAid and try to pick it up, since this has happened before. I had my fiancé call on the way and inquired about the status, I was told that they needed my ID and I would be good to go.

When I get there, I wait in line for 10 min for anyone to even acknowledge me, even though I was the only person in line. The pharmacist then told me that I can only get a 7 days refill, then she changed her mind and I could only get 7 pills total, even though I have been getting my refill every 15 days of 50 pills for the last 6 months that I have been on this dose. She said that my insurance is not allowing her to do more and she would lose her license if she helped me, I informed her that I have not been going through my insurance for the past year, due to them not covering my medication. The previous Pharmacists at that RiteAid  and never lost their licenses, worked with me and were able to get my medication through GoodRx, I never had any issues until last Friday when she blindsided me without any time to fix the issue, due to how late in the day this happened and because it was a C2.

I obviously became very emotional when I was informed that they were doing this and rightfully so, I had called before I got there and received none of this information, because they never bothered to reach out and/or tell me when I called, I was too late to reach out to my providers office that late in the day on a Friday. I had no choice but to take the 7 pills I was offered, otherwise risk going into physical withdrawal.

I was completely humiliated by the Pharmacist and made to feel like I was less then human, as she allowed a line to form to witness my humiliation, just because I have a chronic pain condition. I already have to deal with the stigma associated with taking a controlled medication but then I also have to deal with the judgement and bias every time I try to get it filled by the unprofessional Pharmacist that works there. I work a full time job and live a very full life and am able to do this because of the medication I am on to control my issues associated with my TBI, I am not some junkie trying to get one over on someone. I have been getting my medications filled at RiteAid because prior to this new pharmacist taking over, I was always treated with dignity and respect. As I was leaving the store, a sales associate saw me crying and pulled me to the side to find out what was wrong. She listened intently and asked me to write my information and story for the store manager because this is a new pharmacist and she indicated that she has been a problem for lots of people since starting. As of right now, I have not received a call from the manager.

As an American with a chronic pain condition, my rights are protected by the ADA, in fact I have an ADA contact with my current employer due to my issues. As such, the pharmacist violated my ADA rights by refusing to fill the RX written by my provider. The way I see it, that means RiteAid violated my ADA rights, so therefore I will have to fill out an ADA complaint against both RiteAid and the individual pharmacist that denied me the rx as written by my provider. 

As you can see from above, what this pharmacist did was in direct violation of my ADA rights. I will be filing complaints with the Maryland Board of Pharmacy, the ADA, Maryland Medical Licensing Board, and a HIPPA complaint.

If this medication was not a C2, instead being insulin or albuterol, I would have walked out of that pharmacy with my rx, no problem but because I require a controlled medication, my rights are violated. I have worked both as a Case Manager for Adults with Disabilities and currently work for a software company that makes an EHR. I am very familiar with the steps to log a complaint against a company and have done it multiple times, not just for my clients but for myself. I also am very familiar with PDMP and the erx software, as it is all integrated into the software that I work with, I also know that the pharmacist could have easily looked at PDMP and seen that I have not gotten any other controls any place else, only my home pharmacy RiteAid, even after I was discharged from the ED 2/3, I did not get any other meds because I knew I would be ok with my refill coming 2/4.

I am very disappointed with my experience and still feel very humiliated, I know have to either find someplace else to fill this or I am screwed and my quality of life will deteriorate. It is because of people like this pharmacist that genuinely sick people are pushed to the streets for pain relief, thus putting them at risk of death or maiming by overdose.

My insurance provider even offers a discount program similar to GoodRx, which shows they know that this sort of thing can happen and they have established something to help people like me. I have taken the liberty of supplying a link, as well as the screenshot of my medications price.

I would really like to continue my relationship with RiteAid but at this time, I do not see a path forward. I am hoping that this note brings some light to the villainization around people that need controlled substances, as the pendulum has swung so far in the other direction that we are suffering. 

  In reading your email… I was waiting to see two words or phrases … “new Pharmacist” & “female pharmacist”..and  your email did not disappoint me…  over my career the vast majority of female pharmacists I worked with, are typically… single, divorced with kid(s), or married to a loser…  they are the BREAD WINNER…

I have taken the liberty of forwarding your email to a person I  know that is at the “big shot level” at Rite Aid Corporate.  She is not a pharmacist but her Father was.   That being said…  You can file the complaints that you listed… but.. I doubt if anyone will respond and/or dismiss it without any action and/or claim that they don’t have the resources to deal with it.  Given it was late on Fri… IMO… this Pharmacist’s decision was INTENTIONALLY going to throw you into cold turkey withdrawal – since you appear to take 3-4 doses a day.  If you file complaints you might also want to file one with the medical licensing board… since one of the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy…  So, it could be viewed that she was practicing medicine without a license.  A pharmacist – per federal law – can provide the balance of a C-II that was “short filled” – normally because of lack of inventory within 72 hrs… so by the close of business today – you will have forfeited the balance of that Rx.  I suspect that your fiance talked to a pharmacy tech…  it is quite normal for a tech to pull the e-Rx and process it and print the label…  the pharmacist had not seen it yet and the tech got no warnings from the pharmacy software – so the label was printed and waiting for your ID – which would have been scanned at the register when you came to pick it up.

Her perception that she will lose her license for cashing out your Rx… is because the DEA says that it is a RED FLAG for filling a controlled med for CASH – when the pt has insurance …  to the best of my knowledge, there is no ‘DEA EXCEPTION” for a pt that has insurance and they won’t pay for the controlled substance.   I suspect that this pharmacist has not been out of school long and that is what was “stuffed”  into her little brain at pharmacy school.

Rite Aid may have a policy that they will tell you “we can’t force a Pharmacist to fill a Rx”… which is correct… but.. if they are not happy with the decision making processes of a Pharmacist… they can fire them.

The easiest thing for you to do is find a independent pharmacy, where you will be dealing with a Pharmacist/Owner – who tends to be a lot less judgemental…  and more interested in taking care of pt and helping them maintaining their QOL. Take all your Rxs to them,  as you email indicated this pharmacist is a “new one”… so the independent many be getting a lot of pts moving their meds to his/her store … since she started at Rite Aid.  Here is link to find a independent pharmacy by zip code  https://ncpa.org/pharmacy-locator   I had my own independent pharmacy for 20 yrs… I have a good idea of the mindset of those who own their own stores.

please keep me in the loop on how this shakes out

I wanted to fill you in on the latest developments. Like you mentioned on your website, apparently a lot of patients do not take the time to fight back. The district pharmacy manager from Rite Aid called me this morning and profusely apologized for the situation. They are reaching out to my provider right now to get a new rx. He told me that corp was very impressed with my email and how I had everything written step by step what happened. The pharmacist did not do her due diligence and could not come up with a logical excuse for why she would not fill my total rx, only giving me the 7 pills. He was really stuck on the fact that she actually filled the rx but only for a few. He mentioned that if she had such an issue with the rx, she shouldn’t have filled it at all but she did. He said that she should have looked at my history and seen what had been done prior. He commended my knowledge of CRISP and PDMP, he also gave me his personal cell phone number for future use.. I still plan on moving to a new pharmacy but will fill it there this time.

Thank you very much for all your advice and help 🙂

I shared this pt’s email with a friend whose “adult kid”  who is some sort of “big shot” at Rite Aid corporate HQ… and this pt got a very prompt response from the office of the  General Counsel for Rite Aid.  Who apparently reached out to the Rite Aid District pharmacy manager and it appears that some actions were taken on behalf of this pt and her immediate need for pain meds were taken care of.

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Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids -comment period ends 04/11/2022 – SMOKE & MIRRORS

Posted on February 10, 2022 by Pharmaciststeve

This voluntary clinical practice guideline provides recommendations and does not require mandatory compliance; and the clinical practice guideline is intended to be flexible so as to support, not supplant, clinical judgment and individualized, patient-centered decision-making.

https://www.federalregister.gov/documents/2022/02/10/2022-02802/proposed-2022-cdc-clinical-practice-guideline-for-prescribing-opioids

https://www.cdc.gov/opioids/guideline-update/index.html

The update process uses multiple key sources of input.

The 2016 Guideline was developed using the best available scientific evidence and followed a rigorous scientific process. The update to the Guideline is following a similar process and includes several opportunities for community and partner engagement. CDC highly values public engagement and has ensured there are multiple opportunities to hear from and incorporate feedback from patients with pain, caregivers, clinicians, and partners.

https://www.regulations.gov/document/CDC-2022-0024-0001/comment

The above link will take you directly to the web page to post your comments. The verbiage from the CDC on this update to the opiate dosing guidelines first published in 04/2016 they have EMPHASIZED that  NO ONE is MANDATED TO USE THEM. just like the first guidelines in 04/2016.

Which we all know, and many entities/groups have previously stated, they were egregiously  mis-read and mis-applied to the determent of practitioners and those in chronic pain community.  The new verbiage regarding these proposed updates are misrepresenting the quality of the data/studies used to develop those first guidelines… and “The update to the Guideline is following a similar process”  after they were published, it was claimed that the majority of the studies used to come to the conclusions in the guidelines were based on a “quality” of  “3” or “4”… on a scale where “1” is good/excellent and “4” is bad/crappy.  Even though the CDC tried to keep the members of the first committee anonymous, it eventually leaked out that many on the committee were ‘opiophobic’ and/or primary area of medical practice was ADDICTION and/or members of one or more organizations that were well known for their opposition to the use of FDA approved opiates for long term use in treating chronic pain.

After the original guidelines were published, the Veteran Admin, DEA, many states codified them into state statues or various medical practice acts, along with large hospital corporation that encompasses untold number of office practices, as well as many insurance and PBM companies making them part of their policies and procedures.

Given that this revision, the CDC PLAINLY STATES – THEY ARE VOLUNTARY – meaning that no entity that has misapplied the original guidelines – need not make any changes to their current policies and procedures on the prescribing of opiates for the treatment of chronic pain.

That is why I chose the graphic of SMOKE & MIRRORS

link to the entire 212 page proposal

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TikTok shares more of your data than any other app, and a study says it’s not clear where it goes

Posted on February 9, 2022 by Pharmaciststeve

TikTok shares more of your data than any other app, and a study says it’s not clear where it goes  TikTok mostly makes untrackable third-party connections

https://www.foxbusiness.com/technology/tiktok-personal-data-study

A recent study found that YouTube and TikTok collect more personal data than any other social media apps, but how TikTok uses that data remains a complete mystery.

Mobile marketing company URL Genius used the Record App Activity in Apple’s iOS 15.2 to which apps communicate with outside networks. YouTube and TikTok registered the most network contacts at 14 each – a significant jump from the average of 6 connections among other apps, such as Twitter, Telegram, Snapchat, and Whatsapp.

More than the number of contacts was the type of contacts each app made: YouTube made 10 first-party contacts, but TikTok made 13 third-party contacts. The tracking still happened even when users didn’t opt into allow tracking.

“Consumers are currently unable to see what data is shared with third-party networks, or how their data will be used,” the report said, noting that third-party contacts could not be identified.

The U.S. has tried to crackdown on TikTok and its use, with some lawmakers including Sen. Marco Rubio, R-Fla., saying that the White House is moving too slowly to create a cohesive plan.

“TikTok remains a serious threat to U.S. national security and Americans’—especially children’s—personal privacy,” Mr. Rubio said. “The Biden administration undid critical measures that President Trump took against the app, and the timid steps it has taken on data security are not nearly enough.”

SOLAR STORM SENDS SPACEX STARLINK SATELLITES OUT OF ORBITThe U.S. military already banned its members from using the app on government-issued devices.The Biden administration argued that executive orders signed by former President Donald Trump were unenforceable, and any new laws needed careful consideration to ensure they withstand any legal challenges.
The Commerce Department recently submitted recommendations to the White House to further address the risk that data collected on American users by Chinese apps could be shared with Beijing.In a statement, the Chinese Embassy in Washington said the U.S. shouldn’t “overstretch the concept of national security and politicize economic issues.”

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CVS Manager: allegedly said that if Nurse Practitioner did not change her (religious) beliefs she would be fired

Posted on February 9, 2022 by Pharmaciststeve

Fired Nurse Practitioner Charges CVS Pharmacy with Religious Discrimination

https://www.ncregister.com/cna/fired-nurse-practitioner-charges-cvs-pharmacy-with-religious-discrimination

Backers of abortion and contraception access have sought to limit or eliminate religious freedom protections for individuals and institutions that object to abortion, to contraceptives, or both.

A Christian nurse practitioner formerly employed at a CVS Pharmacy in Texas has filed a discrimination complaint, saying that the company illegally discriminated against her on the basis of her religious beliefs against contraception and pressured her to change her beliefs.

Robyn Strader, 72, was a nurse practitioner at the CVS Pharmacy MinuteClinic in the Dallas-Fort Worth suburb of Keller, Texas. She said she had secured a religious accommodation not to prescribe contraception when she was hired in 2015. She was fired in late 2021 after the company decided to end religious accommodations.

“The corporate canceling of faithful religious Americans like Robyn must end,” Christine Pratt, counsel for the Plano, Texas-based legal non-profit First Liberty Institute, said Feb. 8.

“CVS accommodated Robyn for more than six years without any problems,” said Pratt, whose group is representing Strader. “It’s bad medicine to force religious health care professionals to choose between their faith and their job, especially at a time when we need as many health care professionals as we can get.”

Strader discussed her beliefs in her religious discrimination complaint to the U.S. Equal Employment Opportunity Commission.

“I am a Christian and a longtime member of a Baptist church,” she said. “I believe that all human life is created in God’s image and should be protected. For this reason, I cannot participate in facilitating an abortion or participate in facilitating contraceptive use that could prevent the implantation of an embryo, cause an abortion or contribute to infertility.”

Pratt said that on the “rare occasions” when contraception was requested, Strader referred them to another nurse practitioner at her location or to the CVS MinuteClinic two miles away.

This changed on Aug. 26, 2021, when the company said that “all nurses must perform essential services related to pregnancy prevention.” Strader’s manager then told her that the manager’s own supervisor said that the company would no longer honor religious accommodations and that Strader had no religious accommodation on file, Pratt said in a Feb. 8 letter to the Dallas District Office of the EEOC.

Strader’s manager on Sept. 23 allegedly said that if Strader did not change her beliefs she would be fired on Oct. 31. The manager allegedly repeatedly pressured Strader to change her beliefs and CVS allegedly failed to respond timely to three letters from Strader. She was fired on Oct. 31.

According to Pratt, CVS now claims that she had never requested a religious accommodation and that accommodating her beliefs would cause an undue hardship to the company. Strader did request and receive a religious accommodation not to receive a Covid-19 vaccine.

“CVS discriminated against Ms. Strader on the basis of religion when it prospectively preempted all requests for religious accommodations related to contraception prescription, derided her religious beliefs and pressured her to abandon them, discontinued a six-year religious accommodation without cause, refused to consider her request for an ongoing religious accommodation, failed to engage with her about possible accommodations, and terminated her because of her religious beliefs,” Pratt’s letter said. “In these ways, CVS violated Title VII of the Civil Rights Act.”

CNA sought comment from CVS Pharmacy but did not receive a response by deadline.

First Liberty Institute said Strader has taught science in high school and at the pre-professional level. Among her other credentials, she holds a Ph.D. in health education from the University of Toledo Medical Center and a master’s degree in nursing, education and family nurse practitioner from Texas Woman’s University.

Backers of abortion and contraception access have sought to limit or eliminate religious freedom protections for individuals and institutions that object to abortion, to contraceptives, or both.

Catholic institutions spent years opposing a federal mandate that required employers to provide health plan coverage for contraception, including drugs that can cause abortion.

Recent controversies surrounding mandatory Covid-19 vaccinations and other measures related to the pandemic have also prompted debates over religious freedom protections and exemptions.

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figures never lie and liars always figure

Posted on February 9, 2022 by Pharmaciststeve

there is a old saying, that figures never lie and liars always figure…  these charts are plotting the same numbers on opiate/illegal drugs OD’s. Except the first graphic, appears to be created by someone/entity that wants more restrictions on Rx opiates – just look at the insert box on the right of the graphic  – BOLD EVIDENCE BASED ACTIONS NEEDED.  The same chart shows abt 30 OD/100,000 population… where the other chart topped out at 12 OD/100,000…  Amazing how someone can make a chart look REALLY BAD… by taking all the various OD numbers and combining – 6 different illegal substances into a SINGLE LINE GRAPH.  One thing that they both show is that soon after the CDC guidelines were published,  opiate OD’s.. increased dramatically and they seemed to increase more in the last year – after the new administration came to power and now our southwestern board is WIDE OPEN and according to the media the Mexican cartels are taking full advantage and we have a tsunami of illegal substances coming across our border.  The graphics can be clicked on and they should open in a new tab and should enlarge

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American Society of Anesthesiologists (ASA) journal: Exparel is not an effective analgesic

Posted on February 9, 2022 by Pharmaciststeve

Judge Tosses Drug Company’s Libel Lawsuit Against Medical Society

— “Pharmaceutical companies are not free to intimidate the scientific process,” says ASA President

https://www.medpagetoday.com/special-reports/exclusives/97077

A federal court in New Jersey has dismissed a pharmaceutical company’s lawsuit against a medical society, its flagship journal editor, and contributing authors that claimed articles it published were libelous and damaging to the reputation of the company’s pain drug.

U.S. District Court Judge Madeline Cox Arleo ruled that statements made in articles in the American Society of Anesthesiologists (ASA) journal Anesthesiology about Pacira’s pain drug Exparel (bupivacaine) were scientific opinions that by their nature can’t constitute defamation.

“The peer-review process — not a courtroom — thus provides the best mechanism for resolving scientific uncertainties,” Arleo wrote in her opinion.

Pacira filed the suit in April 2021 against the ASA, the editor-in-chief of Anesthesiology, and 11 contributing authors, alleging that three articles about Exparel published in the February 2021 issue of the journal, along with a related podcast and continuing medical education (CME) program, created a false impression that Exparel was not an effective analgesic. Thus, the company sought retractions of the papers, in addition to unspecified damages.

Pacira’s two key allegations were that the articles were “scientifically unsound,” and that the journal failed to disclose that certain authors received payments from its competitors.

ASA President Randall Clark, MD, told MedPage Today that the judge ruled that the payments were minimal and unlikely to affect an author’s judgment.

The other allegation focused on whether the methodology used in the studies was accurate and whether studies were excluded improperly, Clark said.

“The judge clearly stated that’s a discussion for scientists to debate during the peer review process and then after publication, in either the refutation of an article through a subsequent study, or solidifying the finding by separate studies finding the same thing,” Clark told MedPage Today.

“This decision from the federal court makes clear that pharmaceutical companies are not free to intimidate the scientific process by filing lawsuits,” he said in a statement published by the ASA.

“The essence of scientific progress is conducting scientific studies, [followed by] the publication of those studies … for making it available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design,” Clark told MedPage Today. “That’s how we make medical progress. … There was a significant threat to that system of medical progress by this lawsuit. So we’re very pleased that the judge found in our favor.”

Tony Molloy, chief legal and compliance officer for Pacira, said in an emailed statement that the papers’ conclusions remain “severely flawed, plagued by personal biases and the intentional use of widely rejected analytical methods.”

“The Court reached a blanket conclusion that, even when ‘methodologically flawed,’ absent fraudulent data, a court cannot determine if a statement in a scientific journal is true or false,” Molloy said in the statement. “Pacira remains confident that continued scrutiny will only further demonstrate the falsity of Anesthesiology’s publications.”

When asked whether the company would appeal the decision, a spokesperson said via email that Pacira is “currently reviewing all of their options.”

Exparel, an extended-release bupivacaine, is a local anesthetic given at the time of surgery to control pain and reduce or eliminate use of opioids afterwards. It was first approved by the FDA in 2011 to treat postoperative pain, and then earned a subsequent indication in 2018 for brachial plexus nerve block, as well as a pediatric indication in early 2021.

Exparel is Pacira’s main product and accounted for about 96% of the company’s total revenues in 2019 and 2020, according to the original complaint.

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nationally-recognized journalist looking to speak with Oregon pain pts who experienced harm due to forced tapering of their opioid pain medication.

Posted on February 9, 2022 by Pharmaciststeve
Help us help you!– National reporter seeking Oregon Medicaid Patients with Back/Neck Pain Who Were Harmed by Forced Tapering from 2015 – Present.
We, the founders of the Oregon Pain Action Group, are assisting a nationally-recognized journalist who has covered our issues and is hoping to speak with individuals who experienced harm due to forced tapering of their opioid pain medication.
In 2016, Oregon Medicaid enacted an unprecedented and radical provision known as Guideline Note 60 (GN60) which required forced tapering of patients who were prescribed opioids for painful conditions of the back, neck, or spine. GN60 was active from January 2016 through January 2021 (with a pause in October of 2019). Even after it was formally withdrawn, no official notice of this change was provided to anyone including CCO’s, prescribers, pharmacists, or patients. It is our observation that the provisions of GN60 live on as unwritten policy within many of the Oregon Health Plan’s CCOs.
The journalist hopes to break this essential story on this massive policy change inflicted on a vulnerable population of Oregon pain patients. This will be a major piece. The journalist has been researching and documenting GN60 and the harms associated with this draconian provision and will confidentially provide patients background information and access to previous pieces he has written about chronic pain. The journalist is interested in speaking with patients (or loved ones of patients), either on or off the record, who have experienced harms including but not limited to:
– elevations in blood pressure and heart rate
– decreased ability to function
– use of opioids from illicit sources
– suicidal throughts / suicide attempt
– death from suicide or accidental overdose
If you were insured through Medicaid and were forcibly tapered from 2015 (GN60’s provisions were implemented in some settings before its official implementation) until now, due to back, neck, or spine pain, please contact us for more information. Even if you were never told about GN60 (as is often the case), you may still have been a victim of it.
If you’d like to learn more, you may either:
1. Contact the journalist directly via email
Oregonpain777@gmail.com
2. Contact Amara and Wendy from Oregon Pain Action Group
oregonpainactiongroup@gmail.com.
We understand typing can be difficult for some patients but if possible, we’d appreciate having a very brief summary of your situation. It would be helpful to know:
– Were you or a family member harmed by forced tapering a Medicaid
recipient at any point between 2016 and now?
– What harms have you experienced as a result of being forcibly
tapered?
– When did the tapering begin?
– What medication(s) were reduced and by how much? (in either
MME’s, milligrams, or number of tablets)
– What types of medication and non-medication therapies are you using
for your pain now or have tried previously in an effort to cope with the
dose reduction?
If you prefer, your identity can be disguised, or you can speak on the record.

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British Medical Journal Blows Lid On Pfizer and Facebook

Posted on February 8, 2022 by Pharmaciststeve

British Medical Journal Blows Lid On Pfizer and Facebook

https://peckford42.wordpress.com/2021/12/22/british-medical-journal-blows-lid-on-pfizer-and-facebook/

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Open letter from The BMJ to Mark Zuckerberg

Dear Mark Zuckerberg,

We are Fiona Godlee and Kamran Abbasi, editors of The BMJ, one of the world’s oldest and most influential general medical journals. We are writing to raise serious concerns about the “fact checking” being undertaken by third party providers on behalf of Facebook/Meta.

In September, a former employee of Ventavia, a contract research company helping carry out the main Pfizer covid-19 vaccine trial, began providing The BMJ with dozens of internal company documents, photos, audio recordings, and emails. These materials revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety. We also discovered that, despite receiving a direct complaint about these problems over a year ago, the FDA did not inspect Ventavia’s trial sites.

The BMJ commissioned an investigative reporter to write up the story for our journal. The article was published on 2 November, following legal review, external peer review and subject to The BMJ’s usual high level editorial oversight and review.[1]

But from November 10, readers began reporting a variety of problems when trying to share our article. Some reported being unable to share it. Many others reported having their posts flagged with a warning about “Missing context … Independent fact-checkers say this information could mislead people.” Those trying to post the article were informed by Facebook that people who repeatedly share “false information” might have their posts moved lower in Facebook’s News Feed. Group administrators where the article was shared received messages from Facebook informing them that such posts were “partly false.”

Readers were directed to a “fact check” performed by a Facebook contractor named Lead Stories.[2]

We find the “fact check” performed by Lead Stories to be inaccurate, incompetent and irresponsible.

— It fails to provide any assertions of fact that The BMJ article got wrong

— It has a nonsensical title: “Fact Check: The British Medical Journal Did NOT Reveal Disqualifying And Ignored Reports Of Flaws In Pfizer COVID-19 Vaccine Trials”

— The first paragraph inaccurately labels The BMJ a “news blog”

— It contains a screenshot of our article with a stamp over it stating “Flaws Reviewed,” despite the Lead Stories article not identifying anything false or untrue in The BMJ article

— It published the story on its website under a URL that contains the phrase “hoax-alert” 

We have contacted Lead Stories, but they refuse to change anything about their article or actions that have led to Facebook flagging our article.

We have also contacted Facebook directly, requesting immediate removal of the “fact checking” label and any link to the Lead Stories article, thereby allowing our readers to freely share the article on your platform.

There is also a wider concern that we wish to raise. We are aware that The BMJ is not the only high quality information provider to have been affected by the incompetence of Meta’s fact checking regime. To give one other example, we would highlight the treatment by Instagram (also owned by Meta) of Cochrane, the international provider of high quality systematic reviews of the medical evidence.[3] Rather than investing a proportion of Meta’s substantial profits to help ensure the accuracy of medical information shared through social media, you have apparently delegated responsibility to people incompetent in carrying out this crucial task. Fact checking has been a staple of good journalism for decades. What has happened in this instance should be of concern to anyone who values and relies on sources such as The BMJ. 

We hope you will act swiftly: specifically to correct the error relating to The BMJ’s article and to review the processes that led to the error; and generally to reconsider your investment in and approach to fact checking overall. 

Best wishes,

Fiona Godlee, editor in chief
Kamran Abbasi, incoming editor in chief
The BMJ

Competing interests:
As current and incoming editors in chief, we are responsible for everything The BMJ contains. 

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