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The voice for pharmacy compounding │ 8 July 2022

 

From APC's President

The threat remains but we can’t afford to fight it


Remember the NASEM “study” in 2020 that recommended that the FDA consider that compounded BHT be considered “demonstrably difficult” and hence illegal to compound? 


As you probably already know, the “study” was not based on science or evidence. It was based on subjective opinion of the “experts” of the Academy and was written with the pre-drawn conclusions of the FDA before the authors even started. This threat still exists.


In 2021, APC started the “Save cBHT” campaign. You can learn more about that at compounding.com. Since 2021, this campaign has reached 25,000,000 patients, prescribers and physicians, has engaged with more than 300,000 stakeholders and has messaged every member of congress about the importance of cBHT.


This is a proactive campaign by APC. I’m sure all of you agree with the old saying: An ounce of prevention is worth a pound of cure. So, we can either continue being proactive and getting patients and lawmakers to contact the FDA before it acts, or we can sit back and be reactive, waiting for the agency to act first. 


Unfortunately, this campaign is broken, and we need your help. Our budget for 2022 is $850,000 but we are nowhere near close to that. If we don’t receive funding fast, this campaign will shut down in July 2022. The profession cannot afford to have that happen and neither can your businesses nor your patients. 


The threat is real. How many of us will go out of business if we lose the ability to compound cBHT? How many of our patients will suffer irreparable harm from loss of this therapy? Help us fight the threat. Contribute today at compounding.com 


• • •


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 three recent stories that you might've missed:

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This week

 

The cBHT campaign has run out of gas

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The good news:

Just two months into the launch of phase two of APC’s Campaign to Save cBHT, the metrics are absolutely stellar:

  • 1,500 new messages to members of Congress
  • 96 new patient testimonials
  • 35,000 page views at compounding.com
  • 15 million impressions – that’s eyeballs on our new campaign ads!


The very bad news:

The above efforts cost money and the campaign is running out of it. We have funding through July 31, and that’s all. No exaggeration here: Without an immediate infusion of funding, we will be forced to pull all search and digital ads through the end of the year, and our ability to afford to maintain compounding.com as the campaign landing page will be unsure.


Here’s what your colleagues are saying about the threat.


Consider this a plea. We have the metrics to prove that the campaign is engaging patients and prescribers and policy-makers in the effort to protect compounded hormone therapy from undue restriction by FDA.


What we don’t have is the money to continue the fight. 


We need to raise at least $200,000 in the next three weeks in order to continue. If your business benefits from compounded hormone therapy, NOW is the time to give. We can’t go on without you. 

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I am APC: Joe Navarra, RPh, FACA

Owner

Town TOTAL Compounding Center

Woodbury, NY


We asked APC member and Board Member Joe Navarra five questions to learn more about him and how he ended up in pharmacy compounding.


How many years have you been a compounding pharmacist? Over 30 years: I started compounding as an intern in college, then as a pharmacist in different capacities in hybrid models. In 2011, I opened the Town Total Compounding Center, a PCAB Accredited, compounding-only pharmacy. 


What inspired you to pursue this career path? After working for many years and navigating issues with insurance companies, I believed I could better help patients if I concentrated on compounding. I like that compounding allows me to make medications using precision care on a patient-to-patient basis.


What is your favorite thing about your job? The best is when you solve a problem for a patient or a prescriber. Usually something that they had no idea could be done, let alone the response from them when the compound works beyond what they thought.


What APC feature (or benefit) has been the most valuable to you? Hard to pick one thing, but I believe that APC has become the voice of advocacy for compounding nationally. For example, Compounders on Capitol Hill helps us get access and face time with legislators to express our concerns, explain what compounding means to patients, and to help our reps understand what legislation is needed, or problems with existing or pending legislation


What else should we know about you? I am an 8th degree black belt in Jui Jitsu. I have trained up and down the east coast, west coast, Hawaii and Japan.


Would you like to be profiled in an upcoming issue of Compounding Connections? Please contact APC's Director of Communications Betsy Keck at betsy@a4pc.org to get started.

Got compounding software questions? We have answers!


You have so many compounding software options to choose from but so little time to spend figuring out which ones are best for your practice.


Stop worrying and start registering for our live webinar on July 21, 20 Questions: Selecting the Right Compounding Software for Your Practice, presented by Alexander Pytlarz, PharmD.


Open to providers starting a compounding pharmacy—or building on an existing one—this program is designed to stimulate thought on the different facets of compounding pharmacy management (e.g., inventory management, compliance, master formulations, and reporting) through a series of 20 compounding management-specific questions that will facilitate the decision-making process when selecting compounding software.


Webinar details

  • Thursday, July 21, 2022
  • 1pm - 2pm EDT
  • Available credit: 0.10 CEU (ACPE); 1.00 Contact Hours
  • Attendance fees:

         -APC Pharmacist Member $55.00

         -Pharmacy Technician or Student Member $35.00

         -Non-member $75.00


APC is pleased to offer this program in partnership with LP3.

 

Save these dates

July 21: FREE APC Briefing: Credit Card Fee Savings


July 21: An APC Webinar, 20 Questions: Selecting the Right Compounding Software for Your Practice with Alexander Pytlarz, PharmD


August 18: An APC Webinar: Hazardous Drug Decontamination – Understanding its Purpose and Validating Best Practices with Abby Roth (registration link coming soon)


September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC


September 22: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART I - PROVIDERS AND PRESCRIPTIONS (registration link coming soon)


October 26–29: PCCA's International Seminar, Houston, TX (in-person + virtual)

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Short takes

FDA grants Paxlovid authority to Pharmacists. On July 6, FDA revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe Paxlovid to eligible COVID-19 patients within certain limitations. Full announcement here.


FDA offers insanitary conditions training. The FDA Compounding Quality Center of Excellence recently announced the availability of a self-guided online course: Insanitary conditions and sterility assurance, the purpose of which is to provide information on how to improve sterility assurance and prevent insanitary conditions to protect patient health.  


June 30 Tech Connect recap. Thank you to everyone who joined last week's Tech Connect call, during which we covered some amazing ground with our pharmacy technician members. For those of you who were unable to attend (or for those who'd like to re-live the experience), here is the link to the recording.

 

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

   


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

  

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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.