The voice for pharmacy compounding | April 1, 2022
From APC’s President
SWOT — a recap
David J. Miller, RPh
Over the past six weeks, we have looked at APC’s Strengths, Weaknesses, Opportunities and Threats (or SWOT).
Our greatest strength is you. Thank you for your support of APC. Thank you for your service to your patients. Thank you for making a difference for your patients and their families.
Our greatest weakness is our lack of members. We are down about 70 percent in membership since 2014. We need your help to reverse this trend. Remember to call one person every week and encourage them to join APC. Sign up one of your technicians as an APC member. Even better, look for news of APC’s new Pharmacy/Facility Membership that we’ll roll out in a few days.
Our opportunities are vast including rebuilding our membership, working with TRICARE to explore new collaborations that will help current and former service members, finding a middle path with FDA that assures patient safety without marginalizing our profession and the patients we serve, strengthening our relationships with members of Congress, working to save cBHT, and increasing the professionalism and recognition of technicians in our profession.
Last are the threats. In many ways, FDA overreach presents the greatest threat to compounded, customized medications and the patients who benefit from them. We are working on many fronts to counter this threat, but we need your help to seize all our opportunities in order to be as strong as possible in diplomacy or battle.
Again, thank you for all you do and thank you for being an APC member.
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.
APC submits amicus brief to preserve California patients’ access to glutathione and methylcobalamin
Supported by its Legal Action Fund, APC will file an amicus brief on behalf of La Vita Compounding Pharmacy in San Diego, which is facing enforcement action from the California Board of Pharmacy.
At issue: California compounders’ ability to compound glutathione and methylcobalamin.
Christine Givant, RPh
Almost a year ago, the California BoP determined that it would not take enforcement action against pharmacies that compounded sterile preparations from bulk ingredients that are on the FDA’s 503A Category 1 bulk substances list, but do not have USP/NF drug monographs. Despite saying that, however, the board continued to initiate enforcement actions in those cases — including targeting APC member Christine Givant, RPh, of La Vita Compounding Pharmacy, who compounded glutathione and methylcobalamin.
APC used its Legal Action Fund to retain attorneys Stephen Snow and Jennifer Bellis of Bendin Sumrall & Ladner, LLC, to write the brief in support of La Vita and all other California-licensed pharmacies. The LAF is funded by an annual voluntary $50 dues-bill gift from renewing APC members. Our goal is to protect patient access to glutathione and methylcobalamin — and to prevent the board’s unlawful prohibition against using these bulk substances to compound sterile drug products.
“The California Board of Pharmacy is trying to impose an arbitrary restriction that is not supported by FDA regulations or California law,” said APC CEO Scott Brunner, CAE. “We’re concerned not only about Christine and La Vita Pharmacy, but that if the California board is able to get away with this, other states will try to follow — and it’s patients who will suffer.”
(The California BoP strenuously objected to APC even being allowed to submit the brief, but the judge was not persuaded by the BoP’s arguments and will allow it.)
Read our more-detailed issue brief for members on the La Vita case here.
Menopause publishes cBHT meta-analysis
A paper co-authored by APC board member A.J. Day, “Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women” was published Thursday in Menopause: Journal of The North American Menopause Society.
Although limited in scope, its unambiguous conclusion: There is no evidence that compounded hormones pose an increased clinical risk compared to FDA-approved products.
Sound familiar? We covered a pre-release of the paper in February; you can read the details on A4PC.org.
MedQuest hosts a big congressional visit
Jeff Bray’s MedQuest Pharmacy in North Salt Lake, Utah, had several members of Congress come by for a tour — and a primer on the issues facing compounding. Check out one of the rather crowded photos:
Front Row (l to r): Rep./Dr. John Joyce (PA), Jim Smith of PCCA, Rep. Cathy McMorris Rodgers (WA), Rep. John Rose (TN), Rep. Debbie Lesko (AZ), MedQuest pharmacist Ryan Young, MedQuest pharmacist Hali O’Malley, Jared Powell (Rep. McMorris’s chief of staff)
Back Row (l to r): Jeff Bray, Joe Lesko (Rep. Lesko’s husband), Tim McMenamin of MedQuest, Nate Hodson (E&C chief of staff to Rep. McMorris), Connor Meyers (Rep. Stewart’s legislative assistant) and Peter Jenks (Rep. Moore‘s district director).
Remember the CompPAC Challenge!
Invite your member of Congress on a pharmacy or facility tour and you can have your donation to their campaign doubled. Just 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.)
Not sure how to set up, prepare for, and conduct a good visit? No worries. Check out APC’s guide, “Hosting a Pharmacy Visit With Your State or Federal Legislators.”
Help save cBHT — and don’t forget the Medisca Match!
Remember: Now through April 15, Medisca will match every new contribution to the Campaign to save Compounded Hormones, dollar-for-dollar, up to $100,000!
That means your support for the next two weeks is doubled thanks to Medisca!
Be ready to talk the thyroid talk with a free CE webinar
Whether it’s dosage limits, allergies, or other issues, commercial thyroid products simply don’t work for every patient. Learn how — and why — to start the conversation with prescribers about compounded thyroid.
APC is offering a free hour-long CE webinar, “Compounded Thyroid: How to Start the Conversation With Your Provider” taught by Michelle Moser, RPh, owner of Maker’s Compounding Pharmacy in Mount Vernon, Wash.
Learn to educate prescribers and patients, and pick up some important best practices for working with thyroid options.
It’s Thursday, April 21, from 2:00–3:00pm EDT, and it provides 1 hour of CE credit. Check it out!
ONE WEEK LEFT to ‘attend’ EduCon! If you haven’t grabbed some of those CE credits, don’t wait!
Polio’s back: After 30 years of being polio-free, it’s reappeared in Africa — likely because Covid-19 interfered with normal health services, and a stark reminder that we can’t ever let our guard down.
Irony watch: Two studies have shown that the live-virus oral polio vaccine provides some protection from Covid-19. “[T]hese live vaccines […] may be used temporarily to protect people in low-income countries that do not yet have access to Covid vaccines.”
Accept Part D insurance? Check those new PBM contracts. NCPA is advising pharmacies to read their upcoming Medicare Part D plan year PBM contracts carefully. Not only may some PBMs be offering reduced reimbursement (potentially below cost), but some have sneaky opt-out contracts.
And that’s that: “Ivermectin Does Not Reduce Risk of Covid Hospitalization, Large Study Finds” — and even the guy whose now-retracted study started the craze (virologist Andrew Hill) agrees. Money quote: “At some point it will become a waste of resources to continue studying an unpromising approach.”
It’s safe to talk: If your smartphone supports voice calling (kids, ask your parents), British researchers studied more than 380,000 women over an average of 14 years, and they’ve concluded that there is no notable risk of developing cancer.
Now through April 8, 2022 — EduCon Virtual 2022
April 21 — APC FREE CE: Compounding Thyroid with Michelle Moser
May 10 — PCCA ACT Virtual Legislative Conference
May 12 — PCCA ACT Virtual Hill Visits
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 firstname.lastname@example.org.