The voice for pharmacy compounding • July 24, 2020
Enjoy our latest edition. Send your suggestions and questions to info@a4pc.org
Shawn Hodges
APC President
(Artist's conception)
Dear friend,

In the world of pharmacy compounding, it’s always something. Despite the integrity and care with which the vast majority of us prepare compounded medications, and despite the great good we do for innumerable patients every day, our profession is always under fire.

It’s true of the ESI/Tricare clawback issue on which APC is fighting for many of you ( read more below).

It’s true of the draft animal compounding GFI that threatens animal health care and will raise costs for pet owners ( read more below about that, too).

And it is urgently true when it comes to FDA’s feelings about cBHRT. Here’s a tidbit for you: 82% of APC members say they derive at least 20% of their business from cBHRT. It’s a big deal, making a big difference for patients.

Thankfully, cBHRT is one issue for which prescribers and patients actually feel as threatened we compounders do, and that’s to everyone’s advantage as we build a coalition in response to the recently released (and FDA-funded) NASEM recommendations on cBHRT.

You’ll find APC’s statement on that NASEM report here, so I won’t restate it. Instead, I want to tell you briefly what your Alliance is doing to get ready for coming attempts by FDA to restrict cBHRT. Our strategy is three-pronged:

Congressional Advocacy. We’re already working with partners to build support for a congressional “Dear Colleague” letter to be sent to FDA from members of Congress, and that’s only the first step in what will be an aggressive effort on our part – along with patient and prescriber groups – to engage members of Congress on this issue.

Data-Gathering. We’ve appointed an all-star cBHRT Task Force, a think tank comprised of physicians, practicing pharmacists, and drug information and formulation experts. Gina Besteman of Women’s International Pharmacy offered to lead the task force (thank you Gina!), with the charge to build a plan for identifying or cultivating appropriate peer-reviewed research and for gathering and aggregating patient outcome data to make our case to FDA. That group met for the first time this week. I listened in, and I have no doubt we have the right folks working to help us build our case for the power of cBHRT in improving lives.

Coalition-Building. Ultimately, our success relies on our ability to engage a diverse group of partners in making a case for the safety and effectiveness of cBHRT. We are reaching out to and working with sister associations, as well as patient and prescriber groups, on this, and we’re open to your suggestions of additional connections we should make.

If you have thoughts on any of these prongs, share with APC’s Scott Brunner. We value your input.

No one knows how quickly FDA will tackle cBHRT. It could well be a year away. Or not. In any case, you can count on APC to be up for the fight.

Now, read on about the five big things you need to know this week!

Best,
Shawn

P.S. Last week we received quite a large gift to APC’s One Fund from a generous investor, which puts us just north of $100,000 received in our quest to raise an additional $150,000 to support APC’s advocacy work through year-end. Thank you to that investor -- and to all of you who have stepped up and given. However, we’re not at the finishing line yet. We must still support the organization to help fight off those that want to close your doors! If you haven’t done so yet, help us meet that goal so we can keep doing the kinds of things you’ll read about below.
You can reach Shawn at shodges@innovationcompounding.com .
August 11 -- Live CE webinar: Putting Safety at the Center of Your Compounding Operation; 2:00 to 3:00 pm EDT

August 25 -- Live CE webinar: Accreditation, Inspection, Credentialing, Oh My!; 2:00 to 3:00 pm EDT

September 29 -- Live CE webinar:
2020 OSHA Training:
Bloodborne Pathogens

August 19; 6:00 to 7:00 pm EDT

September 17; 11:00 am to noon EDT

October 13; 1:00 to 2:00 pm EDT

November 18; 3:00 to 4:00 pm EST
1. The Tricare clawback issue isn't over. Not by a long shot.
Last week, APC, the National Community Pharmacists Association, and PAAS National were invited to participate in a phone call with representatives of ESI and the Defense Health Agency (including DHA's acting chief, Colonel Markus Gmehlin). On that call, we explained in detail the many problems with the Tricare clawback that's affected so many compounders.

What we were told

From Tricare and ESI's perspective, the current suspension of recoupments is expected to be temporary -- an interruption while DHA and ESI reassess the data they used to initiate the clawbacks.

In fact, DHA plans to continue the recoupment once it's cleaned up and reanalyzed that data. Further, it has no plans to return any of the money already recouped until it completes that reassessment, and only if it feels there was an error.

Neither DHA nor ESI addressed the more fundamental issues, such as why pharmacists are being held accountable for alleged 'errors' by physicians, or how they can possibly meet ESI's outrageous (and, frankly, impossible) demands for information.

In response to that meeting, APC, NCPA, and PAAS have sent a detailed letter to Col. Gmehlin, raising specific legal issues with the clawback as a whole, and requesting answers to our questions about how compounders are possibly expected to respond to ESI's unreasonable demands.

You can read that letter here, and we've added it to our Tricare clawback resources page at A4PC.org/tricareclawbacks.

What you need to do

Continue to reach out to your members of Congress to tell them what's happening -- and more importantly, ask them to contact Tricare and tell it to stop these outrageous clawbacks and stand down. Even DHA's Col. Gmehlin was surprised at the extent of our concerns, so it's a fair bet that many of your representatives and senators aren't aware of them.

APC has prepared a short briefing paper designed to be shared with your members of Congress. It explains the issue clearly and succinctly, and it's something you should send to whoever you contact.

Also be sure to take a look at the communications kit you can find on our resources page for tips on reaching out.

APC continues to work hard for you on this issue, so stay tuned for further developments.
2. Compounders on Capitol Hill goes virtual

With the Covid-19 pandemic still in full swing in large parts of the country, and the uncertainty of what the situation will look like in September -- we don't know if congressional offices will be open, nor how many members of Congress will be willing to see visitors.

That in mind, APC has decided to turn Compounders on Capitol Hill into a virtual event. In fact, a series of virtual events.

We're still working out the details, but CCHV will probably consist of an initial half-day in September with continuing ed seminars focused on our advocacy issues, followed by a series of virtual visits with members of Congress through November.

The good news: Going virtual will make it easier to participate -- get your CE and visit your member of Congress from the comfort of home!

Luckily we have a lot of virtual-conference experience to draw upon to make CCH a productive and effective advocacy event. Keep an eye on your inbox (or follow us on Twitter, LinkedIn, or Facebook) for the details next week.
3. Yoho, Pocan, Norcross circulate “Dear Colleague” on GFI #256

Three members of Congress -- Ted S. Yoho (R-FL, also a veterinarian), Mark Pocan (D-WI), and Donald Norcross (D-NJ) -- have written a "Dear Colleague" letter to their peers, asking for signatures on a letter to FDA Commissioner Stephen Hahn. The issue: FDA's GFI #256 on animal compounding.

"This draft guidance would apply a human drug compounding rule to animals," they wrote, "making it more difficult for veterinarians to do their job[s]."
"In the letter, we ask the FDA to identify the specific statutory authority supporting GFI #256, that GFI #256 be modified or withdrawn so that it complies with existing laws, does not increase the cost of animal health care, or restrict safe pharmaceutical options for veterinarians."
You can read both the "Dear Colleague" letter and the letter to FDA by clicking here.

We owe a huge thank you to representatives Yoho, Pocan, and Norcross -- as well as to all those who sign on the letter to Commissioner Hahn. This kind of pressure may be what it takes for the FDA to reconsider a poorly thought-out guidance document.

What you can do: Contact your member of Congress and ask them to watch for and sign this letter from Yoho, Mark Pocan, and Norcross. It's a great opportunity to explain the issue as well.
4. Did you miss our free webinar on going cash-only?
No you didn't!

You can now watch or listen to the full presentation at your leisure.

If you're thinking about switching to a cash-only compounding model, you need this webinar to be sure you're prepared. Check out "Cash-only compounding: pros, cons, and caveats."

You can watch the video or listen to the audio version at A4PC.org/cashonly. Note: This is an informational webinar, not for CE credit.

We owe a special thanks to Hunter Jamerson of Macaulay & Jamerson in Richmond for facilitating a great discussion.
5. CYA with these three webinars

APC continues to expand its educational programs, and we've got four great live courses coming up in the next six weeks. Each offers an hour of CE credit, is only $55 for pharmacist members ($30 for technicians or students), and is taken from the comfort of your home.

As always, you can check out our live and on-demand courses any time at A4PC.org/ce.

Coming soon

The first three rules of compounding are safety, safety, and safety. That means ingraining smart protocols into your entire practice. " Putting Safety at the Center of Your Compounding Operation" will show you the specific operational and transformational changes you need to make. It's August 11, 2:00 to 3:00 pm EDT.

Being accredited, inspected, and properly credentialed are all critical for a compounding pharmacy, but they're very different beasts. Be sure you know which is which and who can provide those services with " Accreditation, Inspection, Credentialing, Oh My!!"; August 25, 2:00 to 3:00 pm EDT.

Protection from the coronavirus pandemic is on a lot of people's minds, and why there are some obvious ways (masks, hand sanitizer), there's another tactic to share with your patients: boosting your immune system. Learn the best supplements to help your body protect itself with " COVID-19 and What You can Do For Your Immune System (and Your Patients)"; September 29, 2:00 to 3:00 pm EDT
We’re grateful for these new APC members who’ve joined since June 1. If your compounding team members and colleagues aren’t members, urge them to join.  And if they use the code APC2020 by July 31, they’ll get $25 off.
Pharmacists
Hamid Bakhteyar; Cary, NC
Matthew Brensel; Walnut Creek, CA
Rachel Burns; Highlands Ranch, CO
David Bush; Birmingham, AL
Pradeep Chilakapati; Newark, DE
Aleksandr Merenkov; Tarrytown, NY
Mike Minesinger; Morton, IL
Michael Reuben; Mequon, WI
Garth Reynolds; Springfield, IL
Sue Smith; New Braunfels, TX
Rebecca Stillo; Whitefish, MT

Pharmacy Technicians
Cohl Adams; Tucson, AZ
Albert Canez; Tucson, AZ
Martika Duarte; Tucson, AZ
Lorena Hurtado; Tucson, AZ
Justin Kays; Tucson, AZ
Houa Lee; Charlotte, NC
Carolina Montano; Tucson, AZ
Arran Montgomery; Columbia, SC
Hugo Reyes; Tucson, AZ
Melissa Rose; Tucson, AZ
Natalie Sebastian; Tucson, AZ
Supporters
Lauren Aller; Naples, FL
John R. Cone, III; St. Petersburg, FL
Joshua DeSilvey;
‌‌ ‌‌ ‌‌ ‌‌ ‌‌ Mountlake Terrace, WA
Casey Gaetano; Atlanta
Stuart Johnson; Aiken, SC
Spencer J. Malkin;
Pompano Beach, FL
Marilyn Morrison Padilla;
‌‌ ‌‌ ‌‌ ‌‌ ‌‌ Lauderhill, FL
Sage C. Wheeler; Bellevue, WA
#PharmacistsProvideCare