APC engaged in the matter because we were—and remain—concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be vague, subjective disciplinary standards. read more →
APC offers a pharmacy/facility membership (PFM) as an alternative to purchasing several individual memberships. This is a relatively new program, so we'd like to thank our 38 PFM members so far for being the trailblazers they are. read more →
In a recent follow-up meeting with APC leaders, FDA’s Center for Veterinary Medicine’s Dr. Bill Flynn acknowledged APC's questions about the practical implications of certain provisions of GFI256 may result in tweaks to the doc. read more →
Established in 1997, the APC Fellows Program distinguishes pharmacists—and, new this year, pharmacy technicians—who are exemplary in their professionalism and commitment to the practice of pharmacy compounding. read more →
On Wednesday, APC leaders met with officials from FDA’s Center for Veterinary Medicine to enunciate concerns about what APC sees as ambiguity and uncertainty in CVM’s final GFI #256, regarding animal compounding. read more →
The voice for pharmacy compounding | March 4, 2022
➤ From APC’s President
SWOT, Part 3
David J. Miller, RPh APC President
Last week, I addressed APC’s greatest strength: YOU.
The "W" in SWOT stands for weaknesses. You may remember that strengths and weaknesses are internal factors to which we all contribute. Let’s talk about our weaknesses.
The greatest weakness APC is currently facing is membership growth and retention. We have gone from more than 2,000 members in 2014 to around 800 today. Even that 800 membership number is a bit inflated because one very supportive, large pharmacy enrolled more than 100 of his technicians. Without this generous enrollment, our membership would be down to about 700 — only a third of what it was in 2014.
Membership drives everything we do. The more members we have, the larger the revenue from membership (duh, right?). But other things you may not consider: The more members we have, the more corporate sponsors are willing to support us because they receive more exposure from their sponsorship. The more members we have, the more potential contributors we have to our political action committee (CompPAC). The more members we have, the more potential contributors we have to our Campaign to Save Compounded Hormones. The more members we have, the more potential contributors we have to the Pharmacy Compounding Foundation. You get the idea. Membership growth has a ripple effect through the entire organization.
Right now, APC has a staff of five. With our current revenues, that’s all we can afford. We run an extremely lean ship, but we need it to grow. To get the staff he needs to accomplish all of APC’s strategic goals, we need about 750 new members. And the thing is, they’re out there. They just don’t yet choose to be a part of their profession’s trade association.
My entire platform as APC’s 2022 president is growing membership.
A few weeks ago, I wrote a column called “The Power of One” and asked — I’m still asking — that each of you make one phone call each week to a fellow compounder and ask if they’re an APC member and if not, to join. I’m also asking that you enroll your technicians and staff pharmacists to become an APC member.
Last, we are all very busy. Make APC a priority in your day. It is the only thing standing between your ability to serve your patients and government agencies that wish to shut you down. When we contact you for membership renewal, please renew promptly.
Everyone reading this is passionate about APC or you would not be a member. Please share your passion with others.
Thank you for all you do and for your help in growing APC’s membership numbers to help address our greatest weakness.
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
APC to FDA‘s Califf: Engage on compounding
APC this week sent a letter to newly confirmed FDA Commissioner Robert Califf, reminding him of the critical role compounding plays for millions of Americans. CEO Scott Brunner pointed out, for example, that Dr. Califf’s patients at Duke University Medical Center likely benefited from some of the half-million doses a year provided by Duke Compounding Facility.
Our hope is that Commissioner Califf will engage with us on compounding issues — cBHT access, adverse-event reporting, FDA’s MOU, and more in ways that previous commissioners have not always done.
To that end, Brunner reiterated APC’s desire to find common (or at least middle-) ground where APC can help FDA “achieve some of its patient safety-focused policy aims regarding compounding, while also elevating the practice of pharmacy compounding and its rightful place in the drug supply chain and American healthcare system.”
On Thursday, an APC workgroup continued a dialogue begun by the Board of Directors in November with chief of the Pharmacy Operations Division at the Defense Health Agency Colonel Markus Gmehlin, and his team. Chaired by Michelle Moser of Makers Compounding Pharmacy in Mt. Vernon, Wash., the workgroup was appointed by APC Board Chair Michael Blaire to explore with TRICARE how APC can assist the agency in preventing fraud, waste, and abuse while also expanding TRICARE coverage of compounded therapies for servicemen and -women.
From APC’s invitation letter to Col. Gmehlin:
There is no avoiding the truth that some pharmacy compounders engaged in TRICARE billing irregularities over the past decade and that our profession has earned a black eye because of those unethical practices. The reason for our interest in an ongoing dialogue with you and your team is to demonstrate our commitment to ethics and professionalism in pharmacy compounding by working with you to develop best practices and implement training to prevent those abuses going forward. We understand that until our industry can demonstrate high integrity in billing practices, TRICARE is unlikely to embrace compounded therapies for servicemembers, despite the positive patient outcomes they can produce and how cost effective they are.
On this week’s call, workgroup members presented the following rough plan of work to TRICARE leaders and asked that this plan be the focus of an ongoing dialogue with the agency:
Develop best practices and training tools for reducing FW&A by compounding pharmacies.
Demonstrate compounders’ commitment to quality, safety, effectiveness, and cost containment.
Demonstrate efficacy of compounded therapy options for major health conditions involving active duty and veteran servicemembers – Traumatic Brain Injury, PTSD and Anxiety Disorder, Non-Opioid Pain Management, and more.
Propose clinical protocols for therapy, labs, patient follow-up, and patient outcome reporting. (Ongoing over the next 12 months)
TRICARE leaders were receptive to the plan and committed to a monthly conversation with APC’s workgroup.
APC-ACHC partnership means $1,000 discount
APC and ACHC — the Accreditation Commission for Health Care — have renewed their partnership, pledging a commitment to advancing the role compounding pharmacies play in communities across the country.
“We continue to see PCAB accreditation as the gold standard for compounding pharmacies,” said APC CEO Scott Brunner, cae. “That’s why we’re delighted to partner with
ACHC to encourage compounders to undertake accreditation as a means of demonstrating
integrity and adherence to the Compounder Code of Ethics.”
The main benefit of the partnership is a $1,000 discount on PCAB accreditation for APC Pharmacy/Facility members. That new member type will be launched at the Owner Summit in Scottsdale later this month.
Medisca to match contributions to save cBHT!
ThANK yoU, Topi-CLICK!
For the month of February, Topi-CLICK matched the first $10,000 of new contributions to the Campaign to Save Compounded Hormones. But APC members did even better: During the month we received new support to the tune of $30,530 from 27 individuals! Thank you all, and thank you Topi-CLICK!
The Owner Summit is just three weeks away!
APC’s Compounding Pharmacy Owner Summit is coming up fast, but there’s still time to register.
The exhibit space has sold out — you’ll find almost three dozen companies and organizations to meet with.
Three pharmacy champions will be in Scottsdale: U.S. congressmen Tom O’Halleran and Buddy Carter, and congressional candidate — and APC member — Rich Moon.
If you’re on the fence, consider this your nudge: Visit A4PC.org/ownersummit to check out all the details, then register today!
Check it out: APC board member Chad Thompson and team from Tri-State Compounding Pharmacy in Cincinnati held a visit last week with Representative Brad Wenstrup. The congressman got a tour before sitting down to talk about some of the big issues facing Tri-State and other compounding pharmacies including urgent use legislation, hormones, and FDA overreach.
Don’t forget 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.)
EduCon isn’t over yet! You can still register and get all those CE credits (and keep your team compliant). It‘s on-demand for six more weeks!
➤ Click for info and to register (if you haven’t already) — or go to A4PC.org/educon
➤ Short Takes
Under your thumb, er, tongue: A new sublingual epinephrine film was as effective as an EpiPen in a clinical trial — in fact, it reached its maximum concentration more quickly than a shot. The film is the size of a postage stamp, doesn’t need refrigeration, can be kept in a pocket, and — if it keeps showing promise — could be used in place of an emergency epinephrine injections.
ACE inhibitors, found University of Minnesota researchers, apparently make opioids work better. That means that combining them with prescription painkillers could mean lower doses of opiates — and less risk of addiction or overdose.