The voice for pharmacy compounding | April 29, 2022
THIS EDITION SPONSORED BY PCCA
IT’S NOT TOO LATE! Take charge of your future and the future of compounding at the 2022 ACT Virtual Legislative Conference, May 10 & 12 — your opportunity to meet with federal lawmakers to communicate concerns about patient access to compounded medications. We’ll match you with your representatives and handle all the logistics. Register now!
From the CompPAC Chair
This week President Dave is way sunning himself on some tropical beach, so we’ve asked APC’s CompPAC Chairman Anthony Grzib to take up the pen. Dave’s column will return next week.
Here’s how to protect your job
Enjoy your compounding job? Fond of your patients and fellow employees? Think it’s all worth preserving and defending? Read on.
Whether you’re an owner, a line pharmacist, or a technician, you need Congress — sometimes to pass bills that help your patients or your businesses, sometimes to prevent a bad idea from becoming law, sometimes to help put pressure on an agency on your behalf. This is a fact of life in a field as regulated and scrutinized (and rightly so!) as pharmacy compounding.
Not every member of Congress will step up when we — when you — need them to, but we want as many as possible to listen to us. And that means electing compounding-friendly legislators in the first place.
Enter CompPAC: Its one goal is to elect and cultivate compounding champions in Congress — men and women who think like you do about pharmacy compounding. CompPAC supports their campaigns, and that support means — while we may not always get their votes, we’ll at least get their ears.
Out of our league
But CompPAC has yet to raise $50,000 in 2022 (mid-term elections!), while Big Pharma spends $233 million per year. Its budget is among the smallest of the PACs associated with our peer organizations. We’re very, very good at stretching our budget, but there’s a limit when you’re outspent $1,863 to $1.
So here’s the ask. No, I don’t expect you all to contribute the $5,000 maximum, but I do expect you — I need you — to give something. To invest $100, or $50, or even $20. Yes, invest: The money you contribute to CompPAC is political insurance — an investment in your livelihood.
It’s a click away. Do it — do something — for yourself, your pharmacy, your patients, and your profession:
This Week
OutcomeMD: For you, for the profession
It’s been a long time coming, but compounders now have a way to turn the success of the therapies they dispense into a powerful tool to help the compounding profession: OutcomeMD.
OutcomeMD allows compounding pharmacies to collect information about how their therapies are working for their patients in a standardized, validated format — the same, in fact, that FDA uses. Collecting and tracking that is good for the pharmacy, but it’s also important for compounding as a whole.
While pharmacy owners get patient-level data about their formulations’ effectiveness, APC gets access to the aggregated metadata — scrubbed of HIPAA-protected details, of course — to share with FDA.
That will allow us to demonstrate in unambiguous terms how patients benefit from compounded therapies. And the more pharmacists who use OutcomeMD, the stronger our case becomes.
Thanks to our partnership with OutcomeMD, APC Pharmacy/Facility Members members receive more than half off OutcomeMD’s standard subscription rates.
Get started
Learn more about everything an OutcomeMD subscription provides at OutcomeMD.com. Then reach out to Lorraine Kaiser at lkaiser@outcomemd.com to schedule your demo. You can even click here to schedule it directly.
Any questions? APC’s Jason Dunn — jason@a4pc.org or (918) 770-6333 — can help.
PFM: for your business
Sure, an APC Pharmacy/Facility Membership is great for each member of your team, but it’s even better for your business. Small or large, joining as a company gives you access to a growing list of valuable services and discounts.
APC’s PFM-members-only Compounded Cost-Charge Tool will help you calculate the cost of your compounds — and the right price to charge for them. Enrollment in APMS will help ensure you’re in compliance with state and federal safety regulations. The weekly Kosar Report will keep you up to date on state compounding legislation and regulation.
And there’s more:
- An annual subscription to NABP’s Survey of Pharmacy Law
- A $1,000 discount on PCAB accreditation from ACHC
- All your locations listed listing in APC’s Compounding Pharmacy Locator
- Half price on a subscription to OutcomeMD for patient-reported outcome tracking
- Waived fees and best pricing for HealNow, a HIPAA-compliant online payment solution for pharmacies
And much more. Check out our PFM brochure and visit A4PC.org/pfm for the details, then upgrade your membership today!
Important peptide clarification
Several members wrote to us after reading last week’s story about compounding peptides to ask “Why are semaglutide and sermorelin exceptions to the peptide rule?”
A good question! For the answer, we reached out to APC Vice President Tenille Davis, PharmD, of Civic Center Pharmacy in Scottsdale. Here’s what she told us:
Sermorelin and semaglutide meet the criteria for compounding because they are part of an FDA approved drug product — one of three criteria we use to determine if an API is eligible to be used in compounding.
They are not considered biologics (which we cannot compound) because they contain fewer than 40 amino acids in their sequence. Keep in mind that we cannot compound a copy of a commercially available medication, but if a patient needed semaglutide in a nasal spray, for example, it would be legal to compound it.
Think of them as commonly used peptides that we compound with, like oxytocin. Oxytocin is a peptide hormone but it is not a biologic.
Level the playing field
HealNow is APC’s preferred online payments platform, and an way for smaller companies to act like the big guns.
HealNow is more than a payment processor. It allows consumers to engage with your pharmacy online: to make co-payments, schedule delivery, purchase OTC items/supplements, and get answers to clinical (and non-clinical) questions — fast and easy.
Make the move to full-service digital, and let HealNow do the heavy lifting. And thanks to our relationship, APC Pharmacy/Facility Members can save a bundle when using HealNow.
Check out what going all-in with digital can do for your pharmacy, and how HealNow can make it happen: HealNow.co. And when you sign up, be sure to tell them you’re an APC member!
With threat looming, patients need your help
All is quiet on the compounded hormones front as we await word from FDA on whether and how it might restrict cBHT. Now is the time we need to be raising the pressure, rallying legislators, patients, and physicians to prevent the loss of this critical therapy.
Problem: It’s almost June and we’re barely halfway to our goal of raising $850,000 for the Campaign to Save Compounded Hormones. That money would pay for stakeholder advertising, practitioner engagement, an expanded compounding.com, more media buys and podcast appearances, and more.
If you haven’t supported the campaign yet, please take a few minutes to read the background on the threat to cBHT, including the debunked NASEM study that’s FDA’s excuse to threaten compounded hormones, what we accomplished last year, and what we’re hoping to do in 2022. It’s all at A4PC.org/cbht.
We need your help — today — to protect the millions of Americans who rely on these treatments.
Short Takes
Stark perspective: Covid-19 has killed a million Americans in a little more than two years, but almost a quarter of the deaths in the last 12 months could have been prevented with vaccination. That’s 230,000 American lives that might have been saved — almost as many as were killed in all of World War II.
Don’t cut funding: APC has joined 66 other patient- and health-related organizations in signing a letter to congressional leaders asking that they restore funding for the HRSA Covid-19 Uninsured Relief Fund, which is not included in the latest budget proposal. The letter asked that Congress act “without delay and safeguard Americans’ access to Covid-19 testing, treatments, and vaccines, and prevent the further dismantling of critical elements of our public health response.”
Perchance to dream: If you find yourself running naked through your high school, late for an exam, being chased by a faceless person on a flaming bicycle … you might be recovering from Covid-19. Apparently frequent nightmares are fairly common after recovery, akin (say Italian researchers) to people with anxiety, depression, and PTSD.
ICYMI: There’s a Mysterious Hepatitis Outbreak among little kids, first in Europe and now in the U.S. and Asia. There have been about 200 cases so far — 10 percent of which required a liver transplant. It’s not caused by any known hepatitis virus, and may in fact be related to an adenovirus, but no one is sure.
Coming Up
May 10 — PCCA ACT Virtual Legislative Conference
May 12 — PCCA ACT Virtual Hill Visits
May 19 – APC Webinar: Compounding for Long Covid – Lessons from the Research (and from the trenches)
May 24 – APC Webinar: Pharmacists Mutual’s Most “Popular” Claims – and How Not to Be One
June 21–23, 2022 — Informa Connect’s Compounding Pharmacy Compliance, College Park, Md.
September 14–15, 2022 — APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC
APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.
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