FDA a step closer to changing Covid vaxes

The other day, the FDA’s vaccine advisory committee^* met to decide what to recommend when it came to new, Omicron-specific vaccines and boosters.

In a surprise to no one, the committee recommended that the original, circa-2020 vaccines be replaced by the combo Omicron shots — and that’s for all doses, from the primary series to any boosters. Everything’s bivalent now!

(Well … that’s assuming the FDA follows the committee’s recommendation. Once upon a time that was a given. These days, who knows?)

^* Technically the Vaccines and Related Biological Products Advisory Committee

Speaking of new vaccinations…

Do NOT wait to get your APhA vaccination certificate!

February 12 is your last chance until the end of May to take the Big Kahuna of immunization certificate courses: APhA’s Pharmacy-Based Immunization Delivery Certificate Training Program.

It’s a total of 23 hours of CE, and it’s the nationwide immunization training you want.

The live portion (8 hours) is being held at GPhA’s North American headquarters in Sandy Springs from 8:00am to 5:00pm on Sunday, February 12.

Space is limited and time is running out.

After you take the live portion, the rest is self study — easy peasy. At the end you get the certificate for your wall and the important line on your CV.

Et tu, antidepressants?

Just because they’re an entirely different type of drug doesn’t mean antidepressants can’t do their part to increase antimicrobial resistance.

Apparently, found Aussie biotechnologists, when bacteria in the lab are exposed to antidepressants for a few days, they “develop drug resistance, not only against one but multiple antibiotics.” As the senior author put it, “This is both interesting and scary.”

You want a bit more science? Here you go:

In bacteria grown in well-oxygenated laboratory conditions, the antidepressants caused the cells to generate reactive oxygen species: toxic molecules that activated the microbe’s defence mechanisms. Most prominently, this activated the bacteria’s efflux pump systems, a general expulsion system that many bacteria use to eliminate various molecules, including antibiotics. This probably explains how the bacteria could withstand the antibiotics without having specific resistance genes.

FDA punts on CBD regulation

When it comes to regulating CBD, the FDA admits it doesn’t know what to do. So it’s punting the question to Congress.

The FDA has strict regs for drugs but not for supplements, so it doesn’t think it has the (clear) authority to regulate CBD products, which, if you believe the hype, can treat anything from mood disorders to itchy toenails.

It’s a legal mess out there: Cannabis is illegal federally, but hemp is legal. CBD isn’t psychoactive, but there haven’t been many good studies about what it can do.

So now it’s in Congress’s lap.

Who’s using sleep meds?

More than 1 in 12 Americans takes some kind of medication to help fall asleep, either prescription or over the counter. That’s the latest data from the CDC’s National Center for Health Statistics.

Some notable takeaways:

• The older people were, the more likely they were to use sleep aids — almost 12% of those over 65 used them most days, compared to only 5.6% of adults under 45.
• Women used them more than men — 10.2% compared to 6.6%. (So yes, women over 65 used them the most: 13.5%.
• The lower the household income, the more likely people were to use sleep meds — by an noticeable but not huge amount.
• White, non-Hispanic people use them the most — a lot more than Black, Hispanic, or Asian folks.

Link above goes to the CDC/NCHS brief; click here for the news story.

Cross Evusheld off the list

The FDA has revoked it’s emergency use authorization for AstraZeneca’s Evusheld Covid treatment saying that it no longer works thanks to Omicron.

It (and AZ) will keep an eye on which strains are circulating in case Evusheld turns out to be effective again. But it seems the days of monoclonal antibodies vs. Covid are over and ritonavir/nirmatrelvir rules the roost.

For now.

Elsewhere: Big Sky edition

Out in Montana, where “rural” takes on a whole new meaning, the state might expand pharmacists’ ability to prescribe certain meds as long as the pharmacist has some added training (and is working with a physician).

Under the bill, pharmacists could prescribe for patients who do not require a new diagnosis, for minor conditions, or in emergencies. They could not prescribe controlled substances.

Naturally, the Montana Medical Association opposes the idea.