Just a few days ago I made this post below, and now the DEA relaxed the rules on prescribing Adderall via tele-video office visits.  I don’t remember seeing that episode on the TWLIGHT ZONE. 

The U.S. is seven months into a shortage of Adderall, a medication for attention-deficit/hyperactivity disorder

https://www.msn.com/en-us/news/technology/drugs-like-adderall-xanax-can-be-prescribed-online-into-2024-us-says/ar-AA1aWRW1

(Bloomberg) — Controlled substances like Adderall will be allowed to be prescribed online into late 2024, US health and drug officials said, reversing their earlier position that restrictions on the drugs would be reinstated as the pandemic eased.  

Health-care providers can prescribe controlled substances online through Nov. 11, according an advance copy of a rule posted online Tuesday. In addition, practitioners who establish relationships with patients on or prior to that date can continue to prescribe controlled substances for an additional year.

“We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for six months while we work to find a way forward to give Americans that access with appropriate safeguards,” DEA Administrator Anne Milgram said in a statement. The rule was issued jointly with the Health and Human Services Department.  

Prior to the pandemic, controlled substances could only be prescribed online for patients who had previously gone to an in-person appointment with the same provider. The DEA waived that requirement as the pandemic shuttered doctors’ offices and clinic, making it easier for people with anxiety, attention-deficit/hyperactivity disorder and opioid use disorder to get medications that previously required many time-consuming, in-person appointments.

Relaxed regulations also led to the development of online companies that connected patients with providers to get these prescriptions. Some businesses have come under scrutiny by the federal government over their prescribing practices.

Easier Access

Easier access to controlled substances was seen as a temporary pandemic measure. But some medical and business organizations said the policy change made it easier to take care of patients and therefore should become the new status quo.

The American Psychological Association and the American Telemedicine Association think the current flexibilities should become permanent, representatives said after the DEA rule was released Tuesday. 

“We’re hopeful there will be no imposition of inflexible, blanket, in-person requirements,” said Kyle Zebley, senior vice president of public policy at the ATA, said in an interview. 

The American Medical Association commended the DEA’s extension without commenting on whether it should become permanent. Bobby Mukkamala, chair of the AMA’s substance use and pain care task force, said in a statement that telehealth prescribing of controlled substances is helpful because it makes it easier for patients to secure and attend appointments.

Earlier this year, the DEA proposed removing many of these flexibilities and gave the public 30 days to provide feedback. Advocacy groups pushed back, saying they feared that the February proposal was rushed and did not give telemedicine companies enough time to prepare and comply to new regulations.

The Biden administration received more than 38,000 comments on the proposed rules, according to a document to be published in the Federal Register.

Too Short

Complying with the agency’s six-week window to return to pre-pandemic restrictions would have been untenable for providers, Zebley said in an interview earlier this month. 

“We thought that 30 days was way too short of a comment period window to draft rules responsibly,“ Zebley said.

The short timeline may have played a part in the DEA’s decision to postpone new restrictions on prescribing, said Mimi Winsberg, cofounder at Brightside Health, an online therapy company.

“I think the DEA had no choice but to extend this ruling because they didn’t have time to process the over 38,000 comments they received on it,” Winsberg said in an interview. “They knew it wasn’t feasible.”

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Notice that the CDC has a WHOLE NEW DIVISION

DIVISION OF OVERDOSE PREVENTION 

Tuesday, May 9th is the second annual National Fentanyl Awareness Day. This observance was founded by parents who have lost loved ones to the drug overdose crisis. The aim of the observance is to raise awareness that people are dying at alarming rates due to illegally made fentanyl, a dangerous synthetic opioid. National Fentanyl Awareness Day is supported by a coalition of issue-area experts, corporations, nonprofits, schools, families and elected officials who are coming together today to spread the word.
Fentanyl is a synthetic opioid that is up to 50 times stronger than heroin and 100 times stronger than morphine. Illegally made fentanyl is a growing threat in the United States and is a major contributor to drug overdose deaths. Even in small doses, it can be deadly. Illegally made fentanyl can be mixed with drugs like heroin, cocaine, and methamphetamine and made into pills that are made to resemble other prescription opioids. Fentanyl mixed with other drugs is extremely dangerous, and many people may be unaware that their drugs include fentanyl.

Of note, fentanyl mixed with xylazine, an animal sedative, has recently been declared an emerging threat in the United States due to its impact on the opioid crisis. Xylazine has the potential to be life-threatening, especially when combined with opioids like fentanyl, and has been increasingly detected in the U.S. illicit drug supply.

The Division of Overdose Prevention in the National Center for Injury Prevention and Control has developed a fentanyl campaign which includes sharable resources to help educate and protect the public from fentanyl-involved overdoses. The campaign resources include factsheets, videos, social media ads, and much more to explain the dangers of illegally made fentanyl and share ways to protect yourself, like using fentanyl test strips and carrying the lifesaving medication naloxone.

On May 9th, take action and help us spread the word about of the dangers of fentanyl and help save lives by preventing opioid overdoses.

	May 9th marks National Fentanyl Awareness Day. Illegally made fentanyl is one of the most common drugs involved in overdose deaths. Join us in raising awareness of the dangers of fentanyl and how to protect yourself or your loved ones from an overdose. Learn more: http://bit.ly/41jGthn

	Today is #NationalFentanylAwarenessDay. Visit our #StopOverdose website to learn about the dangers of #fentanyl, the risks of mixing drugs, how #naloxone can save lives, and reducing stigma toward drug use & recovery: http://bit.ly/3KSA99T #JustSayKNOW

	Fentanyl mixed with xylazine, an animal sedative, is an emerging threat to the U.S. due to its increasing presence in the illicit drug supply. #Xylazine can be life-threatening, especially when combined with #fentanyl. This #NationalFentanylAwarenessDay, learn more about this issue: http://bit.ly/42x5gii

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Over the years, if I had not been able to advocate for Barb -numerous times- when she was hospitalized I believe that I would now have been a widower for years, maybe a couple of decades. I have heard of some interesting adjectives used by hospital staff to describe my advocacy, I can just imagine some that were used that I did not hear about. Some of the staff got to experience my personal philosophy up close and personal – I can be your best friend or your worse enemy – chose wisely- there are no mulligans.

This nurse stated some of the things that I suspected what was being done in numerous hospitals. Hospitals had to cancel all elective surgeries – their CASH COW. I was hearing abt pts being put on a vent when their SaO2 were in the low 90’s. When we had our independent pharmacy we were also a very large Home Medical Equipment vendor –  a major home oxygen vendor.  I am sure that most everyone is familiar with those finger tip Oximeter units to measure SaO2… that now cost <$50 – even my Apple watch-8 will measure SaO2. We had one of the first Oximeter, about the size of a cigar box and cost us $5,000.o0. I  knew that vents should not be used until the pt’s SaO2 gets < 85 – unless you are trying to generate revenue with putting pts on vents way before it was necessary.

A article in my inbox today  https://www.medpagetoday.com/opinion/prescriptionsforabrokensystem/104320 

While payers (Insurance companies ) profit, around 50% of hospitals finished 2022 in the red. Hospital closures mean less patient access, which often leads to worse outcomes for patients.

I could take some educated guesses why the top 5 health insurance companies are so profitable, all own PBM’s and mail order pharmacies. It is referred to as “spread pricing”, but there is a lot of SMOKE & MIRRORS in the creative accounting, so that the parent insurance company can justify the premiums they charge.

https://www.facebook.com/erinmarie05          https://www.nurseerin.org/

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Shortage of penicillin limits access to the go-to drug for syphilis

https://www.nbcnews.com/health/health-news/shortage-penicillin-limits-access-go-drug-syphilis-rcna81777

The shortage of injectable penicillin is the latest in a series of drug supply issues. Pfizer said it’s an indirect effect of the amoxicillin shortage.

The Food and Drug Administration on Wednesday reported a shortage of an injectable form of penicillin, an antibiotic used to treat syphilis and other bacterial infections like strep throat.

The drug joins a growing list of medications facing supply shortages in the U.S. Liquid amoxicillin, another antibiotic used to treat strep, has been in short supply since October, according to the FDA.

The form of penicillin affected, called penicillin G benzathine, is the preferred drug for syphilis, because it can be used in adults, children and pregnant people. It’s often administered in outpatient clinics or urgent care settings. Dosages for both children and adults are in short supply, according to the FDA.

“The nice part about penicillin G benzathine is that you can give it to a pregnant mother and if she has syphilis, it will also treat the baby,” said Dr. Jeremy Cauwels, the chief physician at Sanford Health, a medical system in Minnesota and North and South Dakota. He said pharmacists in his network have been dealing with a limited supply of penicillin since the winter.

Syphilis cases in the U.S. reached a 70-year high in 2021, the last year for which data is available, according to the Centers for Disease Control and Prevention. The sexually transmitted infection can result in organ damage or death if left untreated.

The FDA attributed the penicillin shortage to increased demand. Pfizer, the sole supplier of that form of penicillin in the U.S., pointed to the amoxicillin shortage as the main issue, because it prompted doctors to recommend penicillin instead. The rise in syphilis cases most likely further accelerated demand, the company said.

The amoxicillin shortage arose during a surge of respiratory virus infections over the fall and winter, when the antibiotic was prescribed for secondary bacterial infections resulting from Covid, flu or respiratory syncytial virus.

Amoxicillin has also been used to treat a rise in severe strep cases dating to the fall. In November, the American Academy of Pediatrics recommended penicillin G benzathine as an alternative to amoxicillin for strep throat patients.

Strep throat case numbers remain elevated. The CDC said last week that unpublished data from its national surveillance program showed a five-year high in emergency department visits for regular strep infections in February and March.

Pfizer said it has been delivering more of its injectable penicillin to the market than ever before but still can’t keep up with demand. The FDA said on its website that supply issues are expected to resolve sometime from October to December.

The American Society of Health-System Pharmacists has reported an additional shortage of another form of penicillin, penicillin G procaine, which doesn’t last as long in the body or cross the placental barrier. But Michael Ganio, the society’s senior director of pharmacy practice and quality, said “benzathine is probably a little bit more of a challenging shortage, because it is the drug of choice.”

Overall, the Covid pandemic seems to have worsened drug supply issues, Cauwels said.

New medication shortages increased by nearly 30% from 2021 to 2022, according to a March report from Democrats on the Senate Homeland Security and Governmental Affairs Committee. The reasons, it said, include a surge in demand for certain drugs, overreliance on foreign suppliers and manufacturers’ moving overseas.

The U.S. is seven months into a shortage of Adderall, a medication for attention-deficit/hyperactivity disorder.

 Four cancer drugs, including two common forms of chemotherapy, are under shortage as well, according to the FDA.

Injectable medications are more than twice as likely to experience shortages compared to other forms, such as oral or topical drugs, the Senate committee report said.

Cauwels said his health system doesn’t expect to get additional penicillin supply until the fall, although it is likely to have enough until then. Its amoxicillin supply is also limited, he added, but it’s getting a steady allocation based on what it has used in previous years.

He added that although there are alternatives to Pfizer’s penicillin drug for treating syphilis, other antibiotics come with more side effects.

The injectable penicillin became the go-to, he said, because “we know it always works and we know it’s easy to administer.”

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42 U.S. Code § 1395 – Prohibition against any Federal interference

https://www.law.cornell.edu/uscode/text/42/1395

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