Orally Dissolving Buprenorphine Tied to Severe Tooth Decay, FDA Warns

https://www.medscape.com/viewarticle/966562

Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the US Food and Drug Administration (FDA) warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

Multiple cases have been reported even in patients with no history of dental problems.

The FDA is adding a warning about the risk of dental problems to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth.

The FDA emphasizes, however, that buprenorphine remains “an important treatment option for OUD and pain, and the benefits of these medicines clearly outweigh the risks.”

More Than 300 Reported Cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as these represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.

Recommendations

The FDA says healthcare providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their healthcare provider as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

After the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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RIP Gravestone

My Dear Pain Brothers and Sisters,

I write you this in my last stages of lung cancer. I want to thank all of you for your friendship and support. I wanted to give you a heads up that I will unable to respond to your wonderful sharing once I enter my coma, but I will carry our cause with me. All I’ve ever wanted is to get the laws changed to where no one has to suffer in needless pain again. After 29 years of pain, it’s hard to wrap my head around the fact I’ll finally be out of pain in just a week or so, but I pray you will be also by some of the work I’ve done. I go to our Creator to pray and beg for mercy for all of you. You have my love always.

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Delaware top court says Rite Aid can’t get insurance coverage for opioid cases

https://www.reuters.com/legal/litigation/delaware-top-court-says-rite-aid-cant-get-insurance-coverage-opioid-cases-2022-01-10/

The Delaware Supreme Court on Monday ruled that insurance company Chubb Ltd is not required to provide coverage and defend Rite Aid Corp in lawsuits accusing the pharmacy chain operator of fueling the opioid epidemic.

The ruling came in one of several disputes nationwide involving pharmaceutical companies, drug distributors and pharmacies suing insurers in order to recoup the costs of defending against and settling thousands of opioid lawsuits.

A lower-court judge in 2020 found that various Chubb subsidiaries were required to defend Rite Aid against bellwether lawsuits by two Ohio counties in the federal multidistrict litigation over the epidemic.

But Delaware’s top court reversed, concluding that policies covering personal injury cases did not require Chubb to defend Rite Aid against lawsuits seeking only economic damages.

Rite Aid and its lawyer, Gerald Konkel of Morgan, Lewis & Bockius, did not respond to requests for comment. Chubb and its lawyers, including Jonathan Hacker of O’Melveny & Myers, had no comment.

More than 3,000 lawsuits have been filed nationally by largely state and local governments seeking to hold the companies responsible for an opioid abuse crisis that has led to hundreds of thousands of overdose deaths.

The lawsuits accuse Rite Aid of negligently distributing addictive prescription pain pills. The company denies wrongdoing, and in 2019 sued Chubb to recover the costs of its defense and future settlements.

In Monday’s ruling, Chief Justice Collins Seitz, said that for Rite Aid to receive coverage, the lawsuits needed to be brought by people injured by opioids – individuals suing on their own behalf or anyone who cared for or treated them.

But in the case of Ohio’s Summit and Cuyahoga counties, which brought opioid claims similar to other local governments, they specifically said they were not seeking recovery for any residents’ personal injuries, Seitz said.

They instead sued to recover for injuries the counties suffered by being saddled with the economic burden of higher demands for medical treatment and impacts on their criminal justice systems, Seitz wrote for the 4-1 court.

“This claim is not directed to an individual injury but to a public health crisis,” Seitz said.

Justice James Vaughn dissented, saying Chubb’s policy language should be interpreted broadly to cover all damages an organization could bring against Rite Aid for the care, loss of services or death of someone due to opioid addiction.

The case is ACE American Insurance Co, v. Rite Aid Corp, Delaware Supreme Court, No. N19C-04-150.

For Chubb: Jonathan Hacker of O’Melveny & Myers

For Rite Aid: Gerald Konkel of Morgan, Lewis & Bockius

Read more:

State supreme court overturns broad bar against insurers suing over opioid coverage

Pharmacy chains including CVS helped fuel opioid epidemic, U.S. jury finds

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At home-covid tests won’t be covered by Medicare

https://www.msn.com/en-us/money/personalfinance/at-home-covid-tests-wont-be-covered-by-medicare/ar-AASFCPH

But millions of people—including the uninsured and those on Medicare—are not eligible to get tests reimbursed under this latest measure.

Medicare won’t cover at-home covid tests

Under the plan announced yesterday, people covered by private insurance or a group health plan will be able to purchase at-home rapid covid-19 tests for free or submit receipts to their insurer for reimbursement. US president Joe Biden’s administration also wants to incentivize insurers to work with preferred pharmacies and retailers to cover the costs of the tests up-front, rather than require patients to pay out of pocket.

 

The new measure doesn’t include the estimated 31.1 million uninsured people living in the US, nor most of the 61.5 million (pdf) Americans enrolled in Medicare, the federal health insurance plan for seniors and people with disabilities. For now, they will have to rely on other types of covid testing covered by the government. Some Medicare Advantage plans, which are more comprehensive, may cover the cost of at-home tests.

Over the past two years the US government has offered covid-19 laboratory testing to most individuals—including the uninsured (pdf) and those on Medicare—at no cost. But even as more pharmacies began stocking rapid at-home covid tests, the federal government was slow to make them widely available. Though frequent testing is seen as an effective measure to contain coronavirus spread, rapid at-home covid tests in the US typically cost anywhere from $9 to $24, and have been going for as high as $80 as pharmacies battle supply-and-demand issues.

More people in the US should have access to free at-home rapid tests later this month, when the Biden administration has said it will make 500 million test kits available to anyone who wants them. The Department of Health and Human Services also says it’s providing up to 50 million at-home tests to community health centers and Medicare-certified health clinics to distribute to patients free of cost.

By the time these tests reach everyone who needs one, though, the first wave of the omicron variant will likely have already peaked. But at the very least, manufacturers and public health officials may now be better prepared for the next coronavirus variant.

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from Shasta

It is with great sadness that I have to share with all of you that our good friend and fellow activist, Lisa Pray has passed on. I was asked to let everyone know.
Lisa was always such a fun person to talk with, had a wonderful spirit and cared so very much about our community. Even though she struggled with her health, she never stopped working to raise awareness. She loved making her videos on TikTok and many of us learned so much from her. Her quest for the truth and her joy for activism was a joy to be around. I always appreciated her for giving us all a voice in her room she created “The Painful Truth”. She stood by her friends and her passion really shined through.

I miss you Lisa Pray. I can’t believe that I will never hear your voice again. Thank you for always being such a good friend to me.

RIP Gravestone

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Barb is no longer on Medicare disability – she is just OLD NOW !… so this video is of no real interest to me… but this appears to be made by -maybe – an attorney firm DISABILITY RESOLUTION, PA

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As far as I can tell the Astra Zeneca version of a COVID-19 vaccine was never approved by our FDA.  Because of the “bum’s rush” (operation warp speed) to get a COVID-19 vaccine to market – as I remember – the USA ordered 300-400 million doses prior to that vaccine even getting a FDA EUA (Emergency Use Authorization).  I remember hearing that we sent hundred of millions of doses to India or Pakistan when they had a huge outbreak.

Back in 2020-2021, I remember questioning putting a new medication on the market with < one year of clinical trials – a new med typically takes 10+ yrs to get thru all the appropriate clinical trials and on to the market place..

As part of this “operation warp speed”, Congress indemnified everyone involved in getting these vaccines to market – that they could not be sued for any harm/damages that these vaccines could/would cause.

This video suggests that there was not only some harm to many pts getting these vaccinations, but there may have been some sort of purging of “bad data” and pts with adverse events and the woman in this video read a “suicide letter” from one such pt who experienced such bad outcomes that life was no longer worth living.

I am sure there will be more coming to light in the near/far future.

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https://youtu.be/iGjKHrD1OW0

American Medical Association is asking for your stories. We If you have had problems obtaining proper or any dose of opiate pain medicines. AMA wants to know.

If you have had limitations on your pain medications by pharmacists, insurance companies, ER’s, after surgery or by any doctors NP’s or who ever trying to limiting opioid pain medications including tapering and being cut off.

send your BRIEF story to AMA to be counted. see email address below

Yes, I retired but one last video, it wore me out, back to my canoe

Your report needs your name (or the name of a representative, if you are shy), city, state, zip, no address or phone. plus – your primary diagnosis, just 1, what happened to you 1-3 sentences and what medicines were involved( if just a denial to treat AT ALL put “opiate pain medicine”) add the insurance company if they were a problem and thats all. Make it brief they are just counting. Maybe add “suspend cdc guidelines” if u want. Tell friends. spread the word!

EMail report to:
opioidtaskforce@ama-assn.org

They have said they want to hear from as many as possible. JUST DO IT! easy, they are primarily counting

Help get others do this, it is ok if if the sick person cannot do it.

Speak up, someone is listening, doctors not the government.
National Pain Council supports this effort
National Pain Council.org

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The feds are providing this medication at NO CHARGE to community pharmacies and apparently the PBM’s have established a pharmacy reimbursement to fill these medications for pts at a  ONE WHOLE DOLLAR.  Years ago, when I was actively practicing pharmacy  it was claimed that the business overhead in providing/filling a Rx for pts cost abt $12 EACH.  But I retired in 2013, and part of that $12 cost would be the cost of carrying and insuring inventory, so that cost would/could be subtracted from that $12 cost, but NINE YEARS have passed since I last practiced, so nearly a TEN YEAR inflation, would most likely pushed that $12 cost back in 2013 would be much above that $12 dollar figure today.   Just last month the current inflation for Dec 2021 was pushing TEN PERCENT on a annualized basis.   Of course,  the PBM industry has always fought financial transparency and if the numbers on this program are eventually leaked…I would not be surprised to see the PBM’s administration cost could be $20- $30 per Rx – charged back to the federal program.  I would not be surprised that many pharmacies will just “be out of stock” of these two new anti-viral… I doubt that pharmacy software drug to drug interactions system will not be fully updated and I suspect that there is going to be a lot of drug-drug interactions that were not uncovered under the brief clinical trials under the EUA (Emergency Use Authorization).  The Pfizer anti-viral version is known to have many serious drug to drug interactions and possible many undocumented drug to comorbidity health issues and the Pfizer med is reported to be nearly 3 times more effective than the Merck version.

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