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The voice for pharmacy compounding │23 September 2022

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From APC's President

Let's get engaged


But Dr. Dave, I barely know you!


No, not that kind of engaged, but rather engaged in APC and your profession.


In the past year, we have over 2,300 new members in APC. We welcome every one of you. Many of you may not know exactly what APC is yet, or what it has to offer you, but we want you to get involved, because we’re the organization that can assure pharmacy compounding can continue to serve millions of patients across America.


My last initiative as your President—between now and year-end—is to identify what resonates with our members and especially our new members. Most of our new members are pharmacy technicians or staff pharmacists who may not know APC’s role or value. But we’re here to help you. 


I want you to tell me what is important to you. Would you take two minutes of your time to respond to this survey.


I’m very glad you’re a member, that you’ve joined our group of pharmacy compounding professionals, that you want to work with us to elevate our profession.  


We need you to be engaged and to know what you think. The survey, linked above is just the first step. Stayed tuned for more as we begin to implement your responses. Until then: Keep reading Compounding Connections, and stay informed!

• • •


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.

ICYMI

Catch up on these recent stories that you might've missed:

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This week

URGENT:

Deadline for joint Congressional letter on GFI 256 is September 30

One result of last week’s Compounders on Capitol Hill visits has been the creation of a joint congressional letter to FDA’s Center for Veterinary Medicine raising concerns about the great ambiguity in GFI 256 on animal compounding.

 

The bipartisan letter is anchored by Congressmen Mark Pocan (D-WI) and John Carter (R-TX).

 

Here's how you can help:

  • Via the link below, please contact your congressperson and urge them to sign on to this joint letter to CVM on GFI 256.
  • As you’ll read in the message at the link below, they’ll need to contact Penny Stehlik in Rep. Carter’s office at Penny.Stehlik@mail.house.gov to sign on to the letter.


The letter closes September 30, so time is short.

 

By signing this letter, your Congresspeople are helping  to ensure veterinarians and animal patients continue to have access to the compounded medications they need.

 

One more thing: If you know your US House member personally, call, text or email them directly about this IN ADDITION to sending the message via our portal below.


Remember, the deadline to sign is Friday, September 30, 2022.

Click here to send a message to your Congressperson
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Notes from that Gail Bormel interview...

Who knew our CEO’s interview with FDA’s Gail Bormel last week at Compounders on Capitol Hill would prove so interesting—and popular?


We weren't able to record the session, but we did take great notes, and so for everyone who requested the video after the session, here are our notes on Scott’s interview with Gail Bormel. Some highlights:


  • The agency is not interested in adverse events that do not cause or threaten serious harm to a patient.
  • In 2022, 25% of FDA inspections did not result in a 483 for 503A pharmacies.
  • Regarding compounded hormone therapy: if/when the agency takes action, it will be through the formal PCAC process.

Push back against TRICARE network exclusion

Express Scripts (ESI) has slashed pharmacy reimbursements for 2023, making it impossible for many independent community pharmacies to participate in the TRICARE pharmacy network.


ESI has also notified TRICARE beneficiaries that their pharmacy will no longer be in network as of October 24, 2022, instead of the end of December this year. ESI’s actions are creating disruptions for TRICARE beneficiaries and their caregivers, and making it more difficult for many to access their necessary prescriptions.

 

If you would like to take action, NCPA and APC are encouraging pharmacists to use this link to urge your federal legislators to sign on to a letter led by Sen. Tom Cotton (R-Ark.) and Rep. Buddy Carter (R-Ga.) that demands answers from the Department of Defense on the recent TRICARE pharmacy contracts. Don’t delay, as the deadline for Members of Congress to sign on is September 28.

 

For your patients and their caregivers who are experiencing a disruption, please direct them to this NCPA-created resource to take action. Print this letter in your pharmacy and ask your affected patients to sign and mail directly to the Defense Health Agency.  

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CCH: By the numbers. Compounders on Capitol Hill is ALL about getting things done in person, in DC. Last week, our 106 attendees rallied hard for the home team. Our group—representing 34 states—scheduled 162 meetings with their respective Congresspeople to discuss the three priority issues we're facing as compounders.

For PFMs: Protection from legal exposure

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What if APC gave you a tool that would: 


  • Meet state and accreditation requirements that you have a continuous quality improvement program?
  • Allow you to track and learn from your patient safety data without fear of legal exposure?
  • Protect the med safety risk mitigation work you do from blanket requests for safety data?


What would that be worth to you?


The good news is, you already have such a tool through APC's Pharmacy/Facility Membership (PFM). In addition to several other exclusive benefits, PFMs get free membership in the Alliance for Patient Medication Safety, a PSO that provides you those protections.


But first you must become a PFM. Click here or contact Jason Dunn at jason@a4pc.org to learn more about these and the many other benefits that come with being a PFM.

Save these dates

September 27: An ARL Pharma webinar, Compounding Lab Design and Engineering Considerations per USP 800 Guidelines


September 30, 2022: APC 2023 Board of Directors election voting begins. Watch your email for access to your electronic ballot.


October 6: An APC-PCCA webinar on Quality + Compliance


October 13: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART II - WHOLESALE DISTRIBUTORS


October 19: APC 2023 Board of Directors election voting closes.


October 2629: PCCA's International Seminar, Houston, TX (in-person + virtual)


November 10: An APC Webinar: Can You Compound That? A Quiz Show Webinar (details coming soon)


December 8: An APC Webinar: How to Use Medical Literature to Identify and Support Compounded Therapies (details coming soon)


2023

February 9–10: APC's EduCon 2023, virtual (more details coming soon)


March 25–27: APC's Owner Summit 2023; The Grand Hotel Golf Resort + Spa;

Point Clear, AL (more details coming soon)

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Short takes

It’s a David v. Goliath fight: Guess which one you are? Yesterday, we shared with APC members our quarterly e-newsletter on the activities of CompPAC, our association political action committee—and about the David versus Goliath struggle we’re in as election day approaches. If you missed it, catch up here, and maybe send us a CompPAC investment while you’re at it...so we can support more members of Congress who think like you do about pharmacy compounding.

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Quick links



APC Career Center

• Job seekers

• Employers


APC's Code of Ethics


Compounding Connections archive


Compounders on Capitol Hill 2022


Continuing education

• Live webinars

• On-demand webinars


Current issues:

GFI #256 on animal compounding

Urgent-use compounding

Prohibition on peptide compounding

La Vita Case amicus filing

Insanitary Conditions amicus filing


Prescriber Briefing Resources  


Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund


Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members


Affinity service providers

Accounting & Tax Services: Rx Advisors

Audible Sunshine

Office Equipment: TUI Solutions

Online Payments Platform: HealNow

Patient-Reported Outcomes: OutcomeMD

• Shipment Trackers, a shipping costs auditor  

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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.