APC: FDA’s warning letter to university is worth noting

APC News

FDA’s warning letter to university is worth noting

Published May 5, 2022

If you just read the news story, this seems like a not-interesting-to-compounders FDA warning letter — in this case to Miami University of Ohio for “falsifying data.”

But if you read the actual letter, you get a much fuller picture of why MU was scolded for its heparin testing: Test results in an ‘uncontrolled’ folder on the computer. No software audit trail. “All users shared one master login.”

While the biggest problem seems to be “falsified data” — apparently a lazy user who didn’t feel like re-running an analysis — the various issues FDA highlights are worth noting because they’re easy traps to fall into: “Oh, just use my login….”

 

OutcomeMD: For you, for the profession

Published May 5, 2022

It’s been a long time coming, but compounders now have a way to turn the success of the therapies they dispense into a powerful tool to help the compounding profession: OutcomeMD.

OutcomeMD allows compounding pharmacies to collect information about how their therapies are working for their patients in a standardized, validated format — the same, in fact, that FDA uses. Collecting and tracking that is good for the pharmacy, but it’s also important for compounding as a whole.

While pharmacy owners get patient-level data about their formulations’ effectiveness, APC gets access to the aggregated metadata — scrubbed of HIPAA-protected details, of course — to share with FDA.

That will allow us to demonstrate in unambiguous terms how patients benefit from compounded therapies. And the more pharmacists who use OutcomeMD, the stronger our case becomes.

Thanks to our partnership with OutcomeMD, APC Pharmacy/Facility Members members receive more than half off OutcomeMD’s standard subscription rates.

CC: April 29, 2022

Published April 4, 2022

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The voice for pharmacy compounding | April 29, 2022

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From the CompPAC Chair

This week President Dave is way sunning himself on some tropical beach, so we’ve asked APC’s CompPAC Chairman Anthony Grzib to take up the pen. Dave’s column will return next week.

Here’s how to protect your job

Enjoy your compounding job? Fond of your patients and fellow employees? Think it’s all worth preserving and defending? Read on.

Whether you’re an owner, a line pharmacist, or a technician, you need Congress — sometimes to pass bills that help your patients or your businesses, sometimes to prevent a bad idea from becoming law, sometimes to help put pressure on an agency on your behalf. This is a fact of life in a field as regulated and scrutinized (and rightly so!) as pharmacy compounding.

Not every member of Congress will step up when we — when you — need them to, but we want as many as possible to listen to us. And that means electing compounding-friendly legislators in the first place.

Enter CompPAC: Its one goal is to elect and cultivate compounding champions in Congress — men and women who think like you do about pharmacy compounding. CompPAC supports their campaigns, and that support means — while we may not always get their votes, we’ll at least get their ears.

Out of our league

But CompPAC has yet to raise $50,000 in 2022 (mid-term elections!), while Big Pharma spends $233 million per year. Its budget is among the smallest of the PACs associated with our peer organizations. We’re very, very good at stretching our budget, but there’s a limit when you’re outspent $1,863 to $1.

So here’s the ask. No, I don’t expect you all to contribute the $5,000 maximum, but I do expect you — I need you — to give something. To invest $100, or $50, or even $20. Yes, invest: The money you contribute to CompPAC is political insurance — an investment in your livelihood.

It’s a click away. Do it — do something — for yourself, your pharmacy, your patients, and your profession:

This Week

OutcomeMD: For you, for the profession

It’s been a long time coming, but compounders now have a way to turn the success of the therapies they dispense into a powerful tool to help the compounding profession: OutcomeMD.

OutcomeMD allows compounding pharmacies to collect information about how their therapies are working for their patients in a standardized, validated format — the same, in fact, that FDA uses. Collecting and tracking that is good for the pharmacy, but it’s also important for compounding as a whole.

While pharmacy owners get patient-level data about their formulations’ effectiveness, APC gets access to the aggregated metadata — scrubbed of HIPAA-protected details, of course — to share with FDA.

That will allow us to demonstrate in unambiguous terms how patients benefit from compounded therapies. And the more pharmacists who use OutcomeMD, the stronger our case becomes.

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.


PFM: for your business

Sure, an APC Pharmacy/Facility Membership is great for each member of your team, but it’s even better for your business. Small or large, joining as a company gives you access to a growing list of valuable services and discounts.

APC’s PFM-members-only Compounded Cost-Charge Tool will help you calculate the cost of your compounds — and the right price to charge for them. Enrollment in APMS will help ensure you’re in compliance with state and federal safety regulations. The weekly Kosar Report will keep you up to date on state compounding legislation and regulation.

And there’s more:

  1. An annual subscription to NABP’s Survey of Pharmacy Law
  2. A $1,000 discount on PCAB accreditation from ACHC
  3. All your locations listed listing in APC’s Compounding Pharmacy Locator
  4. Half price on a subscription to OutcomeMD for patient-reported outcome tracking
  5. Waived fees and best pricing for HealNow, a HIPAA-compliant online payment solution for pharmacies

And much more. Check out our PFM brochure and visit A4PC.org/pfm for the details, then upgrade your membership today!

Important peptide clarification

Several members wrote to us after reading last week’s story about compounding peptides to ask “Why are semaglutide and sermorelin exceptions to the peptide rule?”

A good question! For the answer, we reached out to APC Vice President Tenille Davis, PharmD, of Civic Center Pharmacy in Scottsdale. Here’s what she told us:

Sermorelin and semaglutide meet the criteria for compounding because they are part of an FDA approved drug product — one of three criteria we use to determine if an API is eligible to be used in compounding.
      They are not considered biologics (which we cannot compound) because they contain fewer than 40 amino acids in their sequence. Keep in mind that we cannot compound a copy of a commercially available medication, but if a patient needed semaglutide in a nasal spray, for example, it would be legal to compound it.
      Think of them as commonly used peptides that we compound with, like oxytocin. Oxytocin is a peptide hormone but it is not a biologic.


Level the playing field

HealNow is APC’s preferred online payments platform, and an way for smaller companies to act like the big guns.

HealNow is more than a payment processor. It allows consumers to engage with your pharmacy online: to make co-payments, schedule delivery, purchase OTC items/supplements, and get answers to clinical (and non-clinical) questions — fast and easy.

Make the move to full-service digital, and let HealNow do the heavy lifting. And thanks to our relationship, APC Pharmacy/Facility Members can save a bundle when using HealNow.

Check out what going all-in with digital can do for your pharmacy, and how HealNow can make it happen: HealNow.co. And when you sign up, be sure to tell them you’re an APC member!

With threat looming, patients need your help

All is quiet on the compounded hormones front as we await word from FDA on whether and how it might restrict cBHT. Now is the time we need to be raising the pressure, rallying legislators, patients, and physicians to prevent the loss of this critical therapy.

Problem: It’s almost June and we’re barely halfway to our goal of raising $850,000 for the Campaign to Save Compounded Hormones. That money would pay for stakeholder advertising, practitioner engagement, an expanded compounding.com, more media buys and podcast appearances, and more.

If you haven’t supported the campaign yet, please take a few minutes to read the background on the threat to cBHT, including the debunked NASEM study that’s FDA’s excuse to threaten compounded hormones, what we accomplished last year, and what we’re hoping to do in 2022. It’s all at A4PC.org/cbht.

We need your help — today — to protect the millions of Americans who rely on these treatments.

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Short Takes

Stark perspective: Covid-19 has killed a million Americans in a little more than two years, but almost a quarter of the deaths in the last 12 months could have been prevented with vaccination. That’s 230,000 American lives that might have been saved — almost as many as were killed in all of World War II.


Don’t cut funding: APC has joined 66 other patient- and health-related organizations in signing a letter to congressional leaders asking that they restore funding for the HRSA Covid-19 Uninsured Relief Fund, which is not included in the latest budget proposal. The letter asked that Congress act “without delay and safeguard Americans’ access to Covid-19 testing, treatments, and vaccines, and prevent the further dismantling of critical elements of our public health response.”


Perchance to dream: If you find yourself running naked through your high school, late for an exam, being chased by a faceless person on a flaming bicycle … you might be recovering from Covid-19. Apparently frequent nightmares are fairly common after recovery, akin (say Italian researchers) to people with anxiety, depression, and PTSD.


ICYMI: There’s a Mysterious Hepatitis Outbreak among little kids, first in Europe and now in the U.S. and Asia. There have been about 200 cases so far — 10 percent of which required a liver transplant. It’s not caused by any known hepatitis virus, and may in fact be related to an adenovirus, but no one is sure.

 

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.


 

PFM: for your business

Published April 4, 2022

Sure, an APC Pharmacy/Facility Membership is great for each member of your team, but it’s even better for your business. Small or large, joining as a company gives you access to a growing list of valuable services and discounts.

APC’s PFM-members-only Compounded Cost-Charge Tool will help you calculate the cost of your compounds — and the right price to charge for them. Enrollment in APMS will help ensure you’re in compliance with state and federal safety regulations. The weekly Kosar Report will keep you up to date on state compounding legislation and regulation.

And there’s more:

  1. An annual subscription to NABP’s Survey of Pharmacy Law
  2. A $1,000 discount on PCAB accreditation from ACHC
  3. All your locations listed listing in APC’s Compounding Pharmacy Locator
  4. Half price on a subscription to OutcomeMD for patient-reported outcome tracking
  5. Waived fees and best pricing for HealNow, a HIPAA-compliant online payment solution for pharmacies

And much more. Check out our PFM brochure and visit A4PC.org/pfm for the details, then upgrade your membership today

Important peptide clarification

Published April 4, 2022

Several members wrote to us after reading last week’s story about compounding peptides to ask “Why are semaglutide and sermorelin exceptions to the peptide rule?”

A good question! For the answer, we reached out to APC Vice President Tenille Davis, PharmD, of Civic Center Pharmacy in Scottsdale. Here’s what she told us:

Sermorelin and semaglutide meet the criteria for compounding because they are part of an FDA approved drug product — one of three criteria we use to determine if an API is eligible to be used in compounding. They are not considered biologics (which we cannot compound) because they contain fewer than 40 amino acids in their sequence.

Keep in mind that we cannot compound a copy of a commercially available medication, but if a patient needed semaglutide in a nasal spray, for example, it would be legal to compound it.

Think of them as commonly used peptides that we compound with, like oxytocin. Oxytocin is a peptide hormone but it is not a biologic.

Cunningham to join APC as public policy director

Published April 4, 2022

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.

Finally: a patient-reported outcomes platform for compounding

Published April 4, 2022

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.

Why not compound peptides and HCG?

Published April 4, 2022

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

Published April 4, 2022

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.

Worth a read (x2)

Published April 4, 2022

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!)

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