Upcoming CE: Breaking through the PBM black box

PBMs have notoriously been a black box of pricing, but that’s starting to change. Join attorneys Payal Amin, PharmD, and A.J. Barbarito as they explain what states and the feds are doing to break through that wall of secrecy.

“State and Federal Regulation of PBMs – Legislative and Regulatory Efforts to Open the Black Box of PBMs” is NEXT TUESDAY, December 8, from 2:00 to 3:00 pm EST. It’s worth an hour of CE credit, and a mere $55 for APC pharmacist members; $30 for technicians or students.

Learn about recent legislative action by states to regulate PBM practices like audits, DIR fees, patient steering, and MAC reimbursement — and maybe get some ideas for your own state. And of course they’ll cover the big SCOTUS case, PCMA v. Rutledge.

Get the details and sign up today: https://a4pc.org/blackbox.

Wanted: Your expertise and engagement

2021 is coming (finally!), and with it new opportunities for you to serve and advance your profession.

One of those opportunities is to lend your expertise as a member of a 2020 APC volunteer committee. Committees are the workhorses of the alliance — you’ll help develop programming, chase possibilities, and recommend policy to the APC Board of Directors.

We’re seeking knowledgeable members for several 2020 APC standing committees:

Applying to serve on any of these committees is simple: just send an email to info@a4pc.org telling us who you are and what committee you’re interested in.

Deadline for nominations is December 4, 2020.

 

32 (and more) thank-yous

A big thank you to the 32 members of Congress who signed a letter to FDA Commissioner Stephen Hahn — a letter urging that the agency not base decisions about compounded hormone therapy on the flawed NASEM study.

“We appreciate the FDA’s dedication to promoting safe dispensing of these hormones,” they wrote, “but we ask the agency to consider the severely negative impact some of NASEM’s recommendations would have on patients.”

And also to ALL the members and friends of APC who called and wrote their representatives to educate them about the issue, and to urge them to sign that letter. Generating this kind of bi-partisan support for an issue isn’t easy, but thanks to you, we’ve done it. Rest assured that APC’s push to protect cBHT, and the millions of Americans it helps, is only beginning.

You can read the joint letter here.

And here is who we have to thank — is your representative on the list?

David P. Roe, M.D.
Mark Pocan
Jaime Herrera Beutler
Henry Cuellar
Andy Biggs
Dan Bishop
Sanford Bishop
Julia Brownley
Buddy Carter
John R. Carter
Peter DeFazio
Mario Diaz-Balart
Chuck Fleischmann
Mark Green
Morgan Griffith
French Hill
Sheila Jackson Lee
John Joyce
Ron Kind
Darin LaHood
John Moolenaar
Alexandria Ocasio-Cortez
Bill Posey
Joseph P. Kennedy III
Debbie Lesko
Greg Murphy
Pete Olson
C.A. Dutch Ruppersberger
Haley Stevens
Steve Stivers
Chris Stewart
Bonnie Watson Coleman

Do you know the right way to handle e-prescribing — in compounding?

Paper prescriptions are well on their way out, so your e-script knowledge needs to be 100 percent up to date.

NCPDP Script 2017071 is the 800-pound gorilla of electronic prescribing, and you’ll want to know it backwards and forwards. APC’s new live webinar, E-Prescribing in Compounding, will help you do just that.

Taught by pharmacy compounding technology expert (and CEO of ElectricLab Software) Michelle Wong, PharmD, E-Prescribing in Compounding will teach you why 2017071 applies to you, how to use it best, and how it can help you collaborate with prescribers to enhance continuity of care.

E-Prescribing in Compounding is Tuesday, December 15, from 2:00–3:00pm EST. A mere $55 for APC pharmacist members; $30 for students or techs. Non-members pay $75. Gives 1 hour of ACPE-accredited CE.

Go to A4PC.org/escripts to register today!

Can you compound peptides?

You’re too beautiful for prison — that’s why you need to learn The Truth about Peptide Compounding with APC’s newest live CE webinar.

You’ve probably seen marketing emails and how-to courses touting compounded peptides. You may have been asked to do it by prescribers. But when — if ever — is it legal? FDA has explicit rules that restrict what 503A pharmacies can compound and dispense, and you do not want to be on the wrong side of the law.

What does the science say? What does the FDA say? What does the law say?

PCCA’s Matt Martin and attorney (and FDA/DEA expert) Karla Palmer have the answers. They’re teaching The Truth about Peptide Compounding on December 2, from 2:00 to 3:00 EST. Don’t take the chance. Register today.

Compounding supporters win races

Congrats to APC member Diana Harshbarger (TN-1), who will become the first compounder in Congress with her victory Tuesday. (Buddy Carter, GA-1, currently the only pharmacist in Congress, was reelected as well.)

And congrats to Alabama pharmacy owner Jerry Carl on winning Alabama’s 1st district seat! We were happy to be among his supporters and we look forward to working with him in Congress.

These are the kinds of compounding-friendly faces that APC — and, more importantly, CompPAC, supports.

 

New CE webinar from APC: Electronic prescriptions

It’s the 500-lb gorilla of electronic prescribing, and you’ll want to know it backwards and forwards. It’s NCPDP Script 2017071, and APC’s new live webinar, E-Prescribing in Compounding, will help you do just that.

Taught by pharmacy compounding technology expert (and CEO of ElectricLab Software) Michelle Wong, PharmD, E-Prescribing in Compounding will teach you why 2017071 applies to you, how to use it best, and how it can help you collaborate with prescribers to enhance continuity of care.

E-Prescribing in Compounding is Tuesday, December 15, from 2:00–3:00pm EST. A mere $55 for APC pharmacist members; $30 for students or techs. Non-members pay $75. Gives 1 hour of ACPE-accredited CE.

Go to A4PC.org/escripts to register today!

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Foundation to fund NASEM study analysis

This week the Pharmacy Compounding Foundation voted to take a leadership role in the effort to protect cBHT. The Foundation board approved substantial funding for an objective, third-party, comprehensive analysis of the NASEM cBHT study.

What that means

There’s much to question about NASEM’s FDA-funded cBHT study:

Right now, that NASEM study carries a strong sense of legitimacy simply because there’s been no comprehensive, objective effort to refute it. But its flaws mean it must not come to be seen as the definitive word on the safety efficacy of cBHT. Thanks to the foundation, it won’t be.

The foundation-funded analysis of the NASEM study should be available by early 2021. Our aim will be to share it with FDA officials, as well as members of Congress and the news media.

This isn’t an inexpensive undertaking, and PCF deserves kudos for its leadership in funding the analysis. Keep that in mind, and please, give to the foundation. Help support it, so it can help support the practice and future of compounding.

Donors in the past have made this coming analysis possible; they paid it forward. Now it’s your turn to do the same.

Personal or corporate, your donations to the foundation are tax-deductible. And there’s no better time to support the foundation as it takes the lead in the fight for cBHT.

Tempted by peptides? Don’t do it.

Yes, like you, we’ve seen those recent marketing emails and how-to CE courses touting compounded peptides, many of them supported by prescribers. Remember that FDA does not control the practice of medicine, and education can be provided on any topic. Many in the physician and education world may be unaware of restrictions on peptide compounding, and some may be asking you to prepare the products they have been learning about. But FDA has explicit rules that restrict what 503A pharmacies can compound and dispense. Using any chemical as an active ingredient in a human compound is not allowed unless:

  1. It has a USP monograph; or
  2. Is an ingredient in an FDA-approved drug; or
  3. Is on the FDA 503A “positive” list; or
  4. Is on Category 1 of FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.

Most peptides do not currently meet any of those conditions.

We know you may be getting pressure from certain physicians to compound peptides, and we understand you risk losing the relationship with that physician by saying no. It’s a hard choice to make. But the rules are the rules, like them or not, and compounders who compound peptides are not just inviting FDA scrutiny, but they risk giving the rest of your rule-following profession a black eye. Until it’s legal, don’t compound peptides that don’t meet 503A active ingredient criteria.

APC at work: California

California’s Board of Pharmacy is considering a rather overzealous attempt to limit animal compounding from bulks, and APC is happy to support our friends at the California Pharmacists Association with a letter to the BoP opposing those changes.

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