The photo inset below on the left was taken last Friday morning at Preston’s Pharmacy (a PFM, I might add) in Arlington, Virginia. It’s not a pharmacist or technician in the photo. It’s a healthcare reporter. read more →
Patient safety is job one in any pharmacy, but especially in compounding pharmacies. So on those rare occasions when errors occur — in your pharmacy or someone else’s — you want to be able to learn from them. read more →
In response to inquiries from state boards of pharmacy regarding the enforceability of revised USP Chapters <795>, <797>, and <800>, a recent memo aims to clarify references in the Food, Drug & Cosmetic Act. read more →
The voice for pharmacy compounding | February 18, 2022
➤ From APC’s President
SWOT — Part 2
Last week, I introduced the concept of SWOT and what it means to APC as an organization. Let’s journey together further in this analysis as it pertains to APC.
The “S” in SWOT stands for strength.
YOU are APC’s greatest strength. I have never had the pleasure of knowing a group of professionals more dedicated to a profession — our profession — than the members of APC.
David J. Miller, RPh
You are committed to your profession. I talk with hundreds of pharmacists and technicians every year. When I ask a chain pharmacist, “How do you like your profession?” in almost every case they say, “I hate it!”
When I ask APC members “How do you like your profession,” I have never been told, “I wish I could do something else.” In every case, the response is, “I absolutely love what I do.” You are fired up and you bring your passion and commitment to your patients and our organization.
Your patients are passionate about customized medications. They support your strength. When you compound prazosin and recommend epsom salt baths for an abused seven-year-old foster child with PTSD, that mom is eternally grateful. She’ll stand up and help you fight your fights. When you compound a 55-year-old’s hormone replacement therapy and it saves their marriage, that gratitude cannot be expressed by words.
You are compassionate. You care for your patients and always have their best interests in mind. You love your patients and they love you.
You are nimble. You continue to look for ways to solve your patients’ unique health challenges. When a manufacturer cannot make a drug, you are there. When a doctor cannot formulate a solution to a patient’s health challenge, you are there — and you succeed.
YOU are APC’s greatest strength. Everything we do, we do because you are a member. Thank you!
David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at email@example.com.
➤ This Week
Please note: APC’s offices will be closed this coming Monday, February 21, in honor of Nova Scotia Heritage Day (and Presidents Day).
Meta-analysis contradicts faulty NASEM report
There is simply no evidence that compounded hormones pose an increased clinical risk compared to FDA-approved products. That is the unambiguous conclusion of a paper published in the prestigious Menopause: Journal of The North American Menopause Society (online now, in print in April or May).
The result: In the few cases where there was enough data, the review found cBHT “is not associated with adverse changes.” This casts further doubt on the accuracy of the report from the National Academy of Science Engineering and Medicine on the same issue — a report based on far less data.
“This is the kind of comprehensive review we would have expected from NASEM,” said APC CEO Scott Brunner, cae. “Instead, NASEM looked at 13 studies that focused on only four hormones, and yet it somehow reached a conclusion — ‘all compounded hormones are dangerous’ — that’s entirely unsupported by evidence.”
What it was supported by, as we’ve shown thanks to a 2021 FOIA request, were FDA’s marching orders.
You might think that, when real evidence comes to light, FDA might reassess its position while it gathers actual evidence. Instead, well, read on….
The letter was in response to those representatives’ December 14 letter to Acting Commissioner Janet Woodcock — a letter expressing concern the agency’s implicit threat to restrict compounded hormones.
Based on the response, FDA appears to be doubling down on its earlier statement that it would base its next steps on the NASEM report, despite that report’s documented bias, conflicts of interest, and lack of scientific rigor.
To be clear, this is bad news. With FDA leaning in to the NASEM report as basis for restrictions on compounded hormones, our effort to engage patients, prescribers, and more members of Congress is even more urgent.
APC’s goal is to raise $850,000 in 2022 for the Campaign to Save Compounded Hormones to pay for stakeholder outreach, to engage practitioners in the effort, to expand compounding.com, and to help spread information through a variety of media channels. Thus far, we’ve raised about $300,000 toward that goal.
Help protect your patients’ access to cBHT — help stop FDA’s misguided effort. Support the Campaign to Save Compounded Hormones. And remember, through the month of February Topi-Click will match any new contribution, dollar for dollar, up to $10,000.
Having trouble recruiting staff? Retaining them?
You’re not alone. Attracting and keeping good employees isn’t rocket science, but it’s not always obvious … or else everyone would do it.
At APC’s 2022 Owner Summit, keynoter Allison Linney will show you the keys to building a culture where people not only want to work for you, but want to stay.
Join compounding pharmacy owners from across the country in Scottsdale, March 24 to 26, for the most important and useful event all year.
We call this the CompPAC Challenge
Here’s a great reason to invite your member of Congress on a pharmacy or facility tour: Have your donation to their campaign doubled.
It works like this:
Host a member of Congress — representative or senator — for a visit to your pharmacy.
Donate at least $500 to their campaign and present it during the visit.
CompPAC will match your donation up to $500. (You’ll need to let us know in advance, of course.)
It’s that simple!
A campaign contribution of $1,000 (or more!) is a great incentive for a legislator to stop by — and a great opportunity for you to talk about some of the issues you face every day. And it’s good for you, too — you’ll have a chance to educate and create a compounding champion who we can count on to support our issues in Congress.
On a related note, please support (support = send him $!) APC member Rich Moon, who is running for Congress in western New York. If elected, he would be only the third pharmacist (and second compounder) in Congress. Learn more about Rich at RichMoon4Congress.com.
FDA warns about compounded ketamine nasal spray
If you compound ketamine nasal spray, be aware that FDA has issued an alert — not a formal warning, just a ‘be aware’ notice — that it has received “a concerning number of case reports of adverse events in recent years.”
Because some of those have been serious, the agency — claiming that 503A pharmacies under-report adverse events — is asking consumers, patients, and health care professionals to be extra vigilant and “report adverse events or quality problems experienced with the use of compounded drugs to FDA’s MedWatch Adverse Event Reporting program.”
EduCon: You can still register and get that sweet, sweet CE
(and keep your team compliant)
➤ Click for info and to register (if you haven’t already) — or go to A4PC.org/educon
➤ Short Takes
Congrats to newly appointed APC board member Sherry Garvin, who was featured in this month‘s America’s Pharmacist magazine from NCPA:
No better time: Remember, your contribution to APC’s Campaign to Save Compounded Hormones will be doubled through the end of the month (up to $10,000), thanks to a generous match from Topi-Click. If you haven’t yet invested in the campaign, now is a perfect time!
APC members are among the best-looking people around, and that’s good news. They (that is, you) are likely to have a better-working immune system according to researchers at Texas Christian University. Why is that? Most likely because people have always been attracted to those who look healthy; i.e., health is attractive, and evolution did the rest.