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APC News

$850,000 to save compounded hormones

Published December 12, 2021

We’ve rolled out plans for Phase 2 of our media campaign to save compounded hormone therapy — but it won’t happen without your support.

APC’s Board of Directors has approved plans for Phase 2 of the association’s three-year, $3 million campaign to save compounded hormones. Phase 2 requires $850,000 in funding — considerably less than last year’s extraordinary $1.5 million fundraising success.

But here’s the thing: This new phase can’t begin until that $850,000 is raised. The new year is coming fast, so the need to achieve that new fundraising goal is urgent.

Included in the 2022 plans are new campaign media featuring a prominent actress-spokesperson, a refresh of the compounding.com landing page and all advertising collateral, and a sharper focus on engaging prescribers — and their patients, too — in the campaign.

(Check out this video briefing on the 2022 cBHT Media Campaign plans.)

Yes, we’re asking you to give — for many of you, to give again — to support year two of this effort.

The good news: We already have about $150,000 pledged. With your continued support, we can make goal — and start this new phase of the campaign — in just a few weeks!

One big aim for 2022 focusing on educating prescribers of compounded hormones about the threat — and through those prescribers, reaching a patient base that doesn’t yet know that FDA may be planning to restrict their compounded hormone therapy.

One big aim for 2022 focusing on educating prescribers of compounded hormones about the threat — and through those prescribers, reaching a patient base that doesn’t yet know that FDA may be planning to restrict their compounded hormone therapy.

You and your relationships with prescribers will be key to that effort.

But we can’t do it without funding. Make your investment NOW.

And don’t forget: You’ll find all sorts of useful tools and resources for engaging patients and prescribers in this effort at A4PC.org/cbhttools.

Thanks. Together, we’ll save compounded hormone therapy and enrich the lives of millions of patients who benefit from it.

 

MOU: Court grants FDA three-month extension

Published December 12, 2021

A Federal District Court has given FDA an extension, until February 2022, to advise the court about whether it will conduct a Regulatory Flexibility Analysis related to its MOU on interstate shipments or declare that the MOU has no economic impact on small businesses affected by the MOU.

In a September 2021 opinion, Federal Judge Chris Cooper had ruled that FDA had not undertaken the proper analysis, remanded the MOU back to the agency, and gave FDA until November 29, 2021, to advise to the court about whether it would undertake the required analysis.

At a Monday hearing, the judge asked the FDA’s attorney to explain its process for certifying whether there is a likelihood the MOU will have significant financial impact due and where FDA was in that process. Ultimately the judge was satisfied that the FDA was moving forward deliberately and not unreasonably delaying the process. However, he did express concern about the impact of that FDA process on the FDA’s current enforcement moratorium — which expires on 10/27/22. Essentially, FDA said they will deal with that deadline if and when they get to it.

The hearing provided some clarity about the certification process, with FDA reporting that its economists are gathering and reviewing data and make the determination on financial impact. The FDA’s attorney admitted that the agency does not have sufficient data sources and said the agency plans to poll state boards of pharmacy and review industry surveys to gather information. Notably, the FDA attorney said that the agency err on the side of not certifying that there will be no substantial impact and in favor of performing a full RFA analysis. She admitted that, particularly in this instance where so little data exists, a full RFA analysis would be a long process that will likely take most of 2022.

Don’t miss Pam Smith 2.0!

Published November 11, 2021

Whether or not you caught Dr. Pam Smith’s “See through the cBHT confusion” webinar, you’ll want to attend part 2 on Wednesday, December 15 at 3:00pm EST. She’ll be covering more of the issues from part 1: cBHT testing, dosing, monitoring, and more. (Let’s put it this way: There’s a lot of misinformation out there.)

Sign up today, then join us virtually on December 15 — and be able to give your team and your patients the latest, most accurate information about compounded hormones. Head to A4PC.org/drsmith!

Prescribers report difficulty with EMR and compounds

Published November 11, 2021

APC has heard that some prescribers are having trouble uploading electronic prescriptions with a powder ingredient — apparently some EMR systems don’t allow “powder” as an option. We’re curious about the extent of the issue.

Would you take our one-question survey to let us know if this issue has affected you at all? It should take you less than 30 seconds.

From APC’s president: Show us the evidence

Published November 11, 2021

At a recent stakeholder meeting of the USP Compounding Expert Committee (CEC), a committee member asked an extremely perceptive and vitally important question: Do we have any evidence that the guidelines we are proposing have any benefit to patient safety?

The ensuing silence was deafening, and it spoke to something that we at APC have maintained for some time: While USP’s proposed guidelines may look good on paper, there is no real-world evidence to support their implementation.

Likewise, there is a desperate need for data about compounded preparations: their safety, their effectiveness and any adverse events caused by the compounding process.

The Pew Charitable Trust published “US Illnesses and Deaths Associated with Compounded or Repackaged Medications, 2001-2019” in March 2020. This project identified 73 reported compounding errors or potential errors associated with more than 1,562 adverse events. This represents the most comprehensive — and perhaps only — listing of adverse events caused by compounded preparations over the past 20 years.

Contamination of sterile products was the most common error; others were the result of compounder’s miscalculations and mistakes in filling prescriptions. A review of all the reported events shows that none would have been prevented by smaller batch sizes, forced-degradation stability studies, or anything else USP is currently contemplating.

The APC BUD Task Force (whose mission has now expanded to addressing all issues with USP) is already in the process of developing a strategy to file comments with USP, but we need your help.

  • We need examples of specific patient populations, medications, and therapies that require BUDs longer than 60 to 90 days.
  • We need data on compounding quality events to identify if root causes were related to compliance with insufficient USP standards or if root causes were related to non-compliance with current standards.
  • Finally, we need to know what steps compounders would need to take to come into full compliance with proposed USP standards to determine the timeline to support a possible request to extend the implementation period to 2 years.

The USP CEC is reasonable and will listen to well-reasoned and data supported arguments. But we need your input in order to make those arguments.

Remember, no matter what your compounding practice looks like, it will be affected by the proposed changes to USP. Large, small, niche, general, human, or veterinary — your patients’ access to the compounds you provide will be adversely impacted. Help APC fight on your behalf. Send us your comments and examples now to info@a4pc.org! Don’t let silence be your answer.

Nominations are open for 2022 APC committees

Published November 11, 2021

2022 is coming, and with it, new opportunities for you to serve and advance your profession.

One of those opportunities is for you to lend your expertise as a member of a 2022 APC volunteer committee. Committees are the workhorses of the Alliance, developing programming, chasing possibilities, and recommending policy to the APC Board of Directors.

We’re seeking knowledgeable members for the following 2022 APC standing committees:

  1. Communications Committee

  2. Education Committee

  3. Federal Legislative Committee

  4. Finance & Audit Committee

  5. Membership Committee

  6. State Legislative Committee

  7. Technician Services Committee

If you‘d like to be considered for appointment, shoot an email to info@a4pc.org, and include the following info:

  1. Your name

  2. Pharmacy/facility name

  3. Town and state

  4. APC committee(s) you’re interested in

  5. A brief description of your expertise in the subject area covered by that committee

Committee requests are due to APC no later than December 3, 2021.

Don’t miss the Tenille Davis show! 📺

Published November 11, 2021

As seen on TV: Check out APC board member Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., in her appearance on AZTV (channel 7 in the Phoenix area) as she talks about why compounding is important, how cBHT is being threatened, and gives one of the best layperson’s explanations of the importance of compounding that you’re likely to see.

Why are you still reading this when you should be watching Tenille?

New CE: What you need to know about your HVAC system

Published November 11, 2021

Sure, your HVAC system might be out of sight, but it can’t be out of mind. That’s why APC is offering a new CE course: “HVAC and Cleanroom Workflow.” It’s next Thursday, November 18, at 2:00pm EST.

Particle counts, changes per hour, the effects of people and the environment — this is stuff you need to know.

Learn more and sign up today at A4PC.org/hvac!

Cut through the clutter: a cBHT webinar with Dr. Pam Smith

Published November 11, 2021

When it comes to compound hormones, there are a lot of misinformation out there — and sometimes even the “professionals” don’t get it right.

For example, dosing is key, but determining it isn’t simple: There’s saliva testing, 4 Methoxy E2 levels, 4 OH E2, urine metabolites, DUTCH tests, VMA, HVA, and a lot more. If you’re confused, you’re not alone.

That’s why APC will be hosting a webinar to help clear it up, with Dr. Pamela Smith — an anti-aging expert, diplomate of the American Academy of Anti-Aging Physicians, internationally known nutritionist/energy coach, radio host, best-selling author … you get the picture.

Dr. Smith will explain to pharmacists and prescribers the best practices of testing and dosing, and she’ll dispel some of that misinformation about compounded hormones.

Join us for “Compounded Women’s Hormones: An Update with Dr. Pam Smith”:

Tuesday, November 16
Noon EST
Registration is $25
Please note that CE credit is not available.

Click here to register.

After registering, you’ll receive a confirmation email with information about joining the webinar.

Mercatus Center releases brief on HR3662

Published November 11, 2021

Urgent-use compounding is one of our major issues, and we’re working on getting HR3662 passed — the bipartisan bill that would allow 503A pharmacies to compound for office use the medications on the FDA Drug Shortage List or the ASHP Drug Shortage List, if those drugs are not available from a 503B outsourcing facility.

Now the folks at George Mason University’s Mercatus Center have released a readable but detailed policy brief that is absolutely worth sharing with your representative: “Allowing Compounding Pharmacies to Address Drug Shortages“.

It covers the rationale for the bill, the legal framework, “How Covid-19 has changed the debate” and even addresses concerns that might be raised. We can’t argue with the conclusion:

When the alternative is no patient access to drugs, there is an easy choice: let compounders provide patients with the medicines they need. Currently, regulatory barriers stand in between patients and drugs in times of distress, but Congress and the FDA can solve these problems.

 

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