You’d think they’d get the message by now

Novo Nordisk is the latest company to have its lawsuit challenging the Inflation Reduction Act’s drug-price negotiation provision thrown out of court. The Danish company argued that having to negotiate violated its free-speech rights (?) and that it was forced to participate in Medicare. The judge was having none of it.

What are we up to? Six of these cases?

Monitor those DOACs

When patients are on direct oral anticoagulants like rivaroxaban, it’s not “fire and forget” — you need to monitor their dosage after that first prescription, especially when it’s being used off label.

The drugs “have their own complicated dosing schemes that can vary based on factors such as kidney function and select interactions between drugs,” and a new study out of Michigan Medicine found that one in eight patients was either under- or over-prescribed a DOAC.

Nearly 70% of the alerts to off-label dosing occurred during a follow up visit compared to the time of the initial prescription […] When prescribers were contacted about the dosing issue, they made changes three-quarters of the time.

FYI

There are eight drugs newly in shortage:

• Basiliximab injection
• Bisoprolol fumarate
• Cyanocobalamin spray
• Disulfiram tablet
• Esmolol injection
• Estradiol cypionate injection
• Indocyanine green
• Orphenadrine citrate injection

Speaking of shortages, there’s Zepbound

Eli Lilly says at least some of its Zepbound-brand tirzepatide will be out of shortage in the coming days. What’s unclear from the Bloomberg article is whether Mounjaro will also be out of shortage. (Both are tirzepatide, but Zepbound is approved for weight loss and Mounjaro is approved for diabetes.)

Tirzepatide itself, the API, hasn’t been in shortage (as compounding pharmacists know), just the delivery systems. If Mounjaro remains in shortage, it means clinicians can still write prescriptions for ‘compounded tirzepatide injections.’ If both are out of shortage, though, it gets problematic.

Don’t peel your own face

The FDA recommends you don’t put acid on your face to peel the skin off — at least not at home. Just because Walmart sells a chemical peel doesn’t mean its safe.

“The agency has not approved any chemical peel products^*, and consumers should only consider using chemical peel products under the supervision of a dermatologist or licensed and trained practitioner.”

^* To be fair, this is disingenuous. The FDA hasn’t approved lipstick either — it doesn’t regulate cosmetics. 

Elsewhere: Peanuts down under

Babies in Australia with peanut allergies will be allowed to take advantage of a free nationwide oral immunotherapy program — the first such program outside a clinical study, available to kids up to 12 months old.

“[It] aims to change the way the most common food allergy in Australian in children is managed, from strictly avoiding peanut in the diet to slowly building tolerance to the allergen and hopefully achieving remission.”

The Long Read: TEFCA and sharing health info

Sharing your medical information in the US is a tough thing. Providers store their info all sorts of ways, which is why there’s still so much paper involved if you change doctors or health systems. Heck, if you get a health app on your phone you still have to type in your info manually.

Clinics, hospitals and health systems can store their information in a variety of formats across dozens of different vendors, and there hasn’t been a trusted nationwide mechanism in place for transporting it securely.

That is changing thanks to TEFCA — the Trusted Exchange Framework and Common Agreement. In broad strokes, it’s a standard for storing and exchanging medical information so participating providers can share it.

Under TEFCA, companies called QHINs (qualified health information networks) are authorized to share health data in different ways. There are six QHINs so far, and they’re like cellphone networks — they connect with other networks. So the SmithCo healthcare network might sign up with one QHIN, and the JonesCo network might sign up with a different QHIN, and they could exchange healthcare data (just like a Verizon customer can call a T-Mobile user).

But QHINs are limited in why they can share that data; they have to be approved for one or more “purposes”:

• Treatment
• Payment
• Health Care Operations
• Public Health
• Government Benefits Determination
• Individual Access Services

Lots of QHINs support the treatment purpose, and they’re all working to support all six purposes.

And now a QHIN called Epic Systems has taken a big step, becoming the first one authorized to exchange healthcare data for individual access services. That’s a big deal for consumers because it means, using Epic, apps on smartphones can accept data from healthcare networks.

For instance, if patients are using a health coaching app or an app that reminds them to take their medicine, they can choose to import their records directly into those platforms. All they need are the credentials they use to sign into Epic.

How those credentials would work — would individuals need an Epic account or would that be up to the app? — isn’t clear.

The point is, this is a big step toward being able to move your data from place to place, provider to provider, and maybe not having to fill out as much paperwork when you switch hospitals.