The voice for pharmacy compounding | April 22, 2022

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From APC’s President

Our undervalued resource

David J. Miller, RPh
APC President

One of the things that bothers me is when I meet someone at a pharmacy conference and ask what they do and they say, “Oh, I’m just a technician.”

WHAT?! JUST a technician? I’ve always valued my technicians as equal to every other team member. They have an equal status with my pharmacists. Why? Because no pharmacy could function without them. They are critical to our profession.

I had three goals when I assumed the presidency of APC: membership, fellowship, and elevation of the status of technicians. Membership is on its way — we’ve gained 1,200 new members already this year thanks to PFM (and most of them are technicians!). And as you’ll soon hear, the APC Fellows Program is back on track. So now we can focus on technician elevation.

Early this year, I formed a new technician committee to examine and implement ways to elevate the status of pharmacy technicians. The committee, co-chaired by Erin Michaels and Stephanie Chacon, has met three times for active discussions about some great ideas, such as technician-specific continuing education programs and technician-specific mixers at events. (And when we learned that in-person CompPAC events were beyond the financial reach of most technicians, I worked with the CompPAC committee to lower the registration fee from $1,000 to $250 for technicians.)

This is just the beginning. Technicians: Tell us what APC can do for you! We need to hear from you. If you have ideas for programs or services, please contact Erin at EMichael@pccarx.com or Stephanie at schacon@empowerpharmacy.com. They would love to hear from you and bring your ideas to the alliance.

Because you’re not just a technician. You’re the backbone of our practice.

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

This Week

Finally: a patient-reported outcomes platform for compounding

Big news for APC Pharmacy-Facility Members: You now have access to a great new compounding-specific patient-reported outcomes tool: OutcomeMD.

It’s an outcome-tracking and marketing platform — an extraordinary strategic tool for the compounding profession and a great business solution for individual pharmacies.

Why it matters

There’s plenty of anecdotal evidence for positive patient outcomes, but not enough of the validated, standardized data FDA wants to see. The OutcomeMD platform will help change that, allowing APC to aggregate patient-reported outcome data while providing compounding pharmacy owners granular data on how their formulations are working for patients.

“The OutcomeMD platform is something long-needed in compounding: A means of collecting and aggregating patient outcomes data in a way that’s not just useful to the pharmacy but useful to the profession,” said APC’s CEO Scott Brunner, CAE.

Via a smartphone app, patients respond to questions about how their specific therapies are working. Owners in turn get data about those formulations using the same validated measures used in clinical trials (and that FDA uses in its database). And, with the owners’ permission, APC gets access to the aggregated metadata — scrubbed of HIPAA-protected details, of course — to share with FDA and demonstrate how patients benefit from compounded therapies.

Benefits to your pharmacy

Using OutcomeMD also provides direct benefits to you and your patients.

  • You’ll have more information about your formulations, allowing you to make adjustments that benefit patients — and to market your services to prescribers.
  • Patients will appreciate the improved customer service; it’s easier for your team to monitor their progress and respond more quickly to questions or concerns.
  • By highlighting success stories, OutcomeMD provides you a powerful marketing tool — it even creates graphics to share on social media and helps patients share their success on review sites.

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.

Reap the benefits of PFM

An APC Pharmacy/Facility Membership isn’t just a smart move for your business, it’s good for your entire team.

Your one annual dues payment covers all your employees, letting everyone benefit from APC membership, with access to the latest news and information, discounted CE and events, detailed issue briefs, and more.

Learn more about all the benefits of Pharmacy/Facility Membership for you and your team, then upgrade your membership today!

Cunningham to join APC as public policy director

It’s been a long time coming, but APC is happy to introduce our new director of public policy: Savannah Cunningham of Myrtle Beach, S.C.

She’ll be responsible for building APC’s relationships and cementing our credibility with state boards of pharmacy and state pharmacy associations (she’s a former employee of the National Alliance of State Pharmacy Associations), as well as supporting our advocacy team in its federal advocacy efforts.

“We’re delighted to have Savannah coming aboard,” said APC CEO Scott Brunner, cae. “Her job will be to assert APC’s influence whenever and wherever compounding policy is being proposed, particularly at the state level. She’ll also provide much needed support for our governmental affairs counsel David Pore.”

A pharmacist and graduate of Mercer College of Pharmacy, Savannah’s interests have always been in pharmacy policy rather than practice — she’s amassed a wealth of experience with state and national pharmacy associations, and is an active leader in NCPA, the Kappa Epsilon Fraternity, and the Rho Chi Pharmacy Honor Society. Her first day at APC will be June 6.

The director of public policy position is funded for the next three years through the vision and generosity of a small group of APC members. We thank them for their leadership.

Why not compound peptides and HCG?

Fairly regularly, we get asked why HCG and peptides can’t be compounded and why APC can’t do something about it. Here’s the skinny:

HCG was swept up in legislation passed by Congress a dozen years ago (but which did not take effect until March 2020) that reclassified a number of substances as biologics, which put them outside the reach of most 503A compounders. Despite our efforts, FDA has shown no interest in exercising enforcement discretion in allowing HCG to continue to be compounded. Over the past 24 months we’ve put out at least two calls for our members to help us collect data demonstrating patient harm — demonstrating that patients have not been able to access essential therapies — that has resulted from the reclassification, but the fact is, we’ve not received any such data. We do believe that kind of data would be useful in making a case to FDA.

“Why not just change the law?” you’re probably thinking. Easy answer: Big Pharma and its regiment of lobbyists. It’s frankly not a Capitol Hill fight we think we can win, and to have to give our limited bandwidth to such a fight will take our attention away from other important and more winnable battles.

Peptides are a bit different. Peptides are not restricted per se. The reason you generally can’t compound them (and there are exceptions, like semaglutide and sermorelin) is because they DO NOT MEET FDA’S CRITERIA: They don’t have a USP or NF monograph, they’re not part of an FDA-approved drug product, and they’re not on the Category 1 or “positive” lists.

And that’s the explanation you should give to prescribers who push you to compound them.

Don’t miss these May webinars

APC has two live webinars coming in May you’ll want to check out. While they don’t give CE credit, they do give you some timely and, frankly, important information for your business.

Long Covid: The pandemic may be winding down, but millions of people are still suffering from long Covid — symptoms that can persist for months. Learn what role pharmacy compounding can play to help their treatment in this joint PCCA/APC webinar. Compounding for Long Covid: Lessons from research (and the trenches)” is May 19 from 3:30–4:30pm EDT.

Insurance claims: Compounders face some insurance claims that other pharmacists don’t, and Pharmacists Mutual wants you to know what they are and how to avoid them. Pharmacist Mutual’s Most ‘Popular’ Insurance Claims in Compounding (and how not to be one of them)” is May 24 from 2:00–3:00pm EDT.

Short Takes

Although we’d quibble with points in FDA’s recent animal health consumer update, it’s distinctive in that it’s the rare instance in which FDA speaks of the essential role of compounded medications in our healthcare system, and that’s progress.

Worth a read #1: “Allowing Compounding Pharmacies to Address Drug Shortages” a policy brief by James Broughel, senior research fellow at George Mason’s Mercatus Center, was published in the March/April print edition of the International Journal of Pharmaceutical Compounding. Broughel’s analysis outlines a necessary pathway for 503A pharmacies to be able to compound shortage drugs — exactly the kind of path envisioned in HR3662, the APC-supported urgent-use bill currently in Congress.

Worth a read #2: Want to stay up to date on the latest in alternative medicine? Check out — and subscribe to — The Townsend Letter. Its latest issue is all about the immune system, including compounded supplements, hormone therapies, nutraceuticals, and more. (And we’re grateful for their ongoing coverage of our Campaign to Save Compounded Hormones, by the way!)

Attention, Okies! The Oklahoma State Board of Pharmacy is looking for volunteers for its task force “for evaluating temperature excursions and the shipping of prescriptions by pharmacies to patients who are located in state and out of state” and creating a rule to address it. If you’re interested, reach out to Marty Hendrick at Mhendrick@pharmacy.ok.gov.

Don’t miss it: If you haven’t already, be sure to mark your calendars for PCCA’s ACT Virtual Legislative Conference (May 10) followed by virtual Hill visits (May 12). Sign up now!


Coming Up

May 10PCCA 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.