The voice for pharmacy compounding  ✸  30 August 2024

Not all heroes wear capes

I’d like to nominate Joe Navarra and Trey Tietz as heroes. Of the week, at least. Maybe even the month.

They’re APC members, both compounding pharmacists. Joe owns Town Total Compounding in Woodbury, NY; Trey is Euclid Avenue ambulatory pharmacy manager with Cleveland Clinic. Regular guys, caring for their patients, engaged in their profession.

But this week they both did something heroic, and compounders across the nation should thank them for it — and, well, emulate them.

If you read this newsletter much, you probably know that Joe chairs the APC Board of Directors and often pens this column. But that’s not why he’s a hero.

What’s heroic is his courage in opening up his Long Island compounding pharmacy to the NBC Nightly News — reporter, TV cameras, on-the-record interview, the whole bit. The resulting story this past Monday is one of the best media reports on compounding that I’ve seen. The patient and provider they feature are almost as good as Joe. Almost. And of course I’m thrilled that the reporter drew from APC’s briefing on compounded GLP-1s and thus gets not only the story but the terminology right.

Why is Joe heroic? Because opening up your pharmacy to reporters is scary. Will it draw FDA scrutiny? A drugmaker lawsuit? Maybe. Are the risks worth the reward? For Joe, the answer is yes, and I’m grateful to him for his courage — and for showcasing his profession so well.

Courage isn’t the only thing that defines a hero. So does competence. This week Trey Tietz showed his to more than 140 Cleveland Clinic prescribers in a “grand rounds" webinar on shortage drug compounding and GLP-1s. It’s a session Trey orchestrated, and I was invited to co-present with him. As he presented, I was struck not only by his quiet competence in briefing prescribers — he did an excellent job — but also by the brilliance of the opportunity he’d created.

Many providers manage to finish medical school without ever hearing about compounded drugs. They can go through years of practice with but a single therapeutic arrow — commercially available drugs — in their quiver. Presentations like the one Trey made yesterday expose them to additional possibilities, therapies that can better serve their patients. And of course Trey’s competence is what gave credibility to that message.

It’s a model that “has legs,” as they say. If you have access to prescriber groups that may be interested in a briefing on shortage-drug compounding (or any other compounding topic), let us know. We’d be happy to collaborate.

Some heroes don’t wear capes. Some are just regular guys like Trey and Joe, whose courage and competence spurs them to do extraordinary things.

—Scott

Scott Brunner, CAE, is CEO of the Alliance for Pharmacy Compounding, and rarely prone to hero worship.

The shortage ends … then what?
(Find out at CCH) 

We’ve added a new session to the Compounders on Capitol Hill lineup. Don’t miss the discussion of what’s on many a compounder’s (and regulators’ … and reporters’...) mind: “After the Shortage: GLP-1s, Continuation of Patient Care, and Compounding,” featuring Karla Palmer of Hyman, Phelps & McNamara, Matt Martin of PCCA, and hopefully Gail Bormel, director of FDA’s Office of Compounding Quality and Compliance.

This is as timely as you can get. GLP-1 drugs will eventually come out of shortage, and that will have seismic implications for patients taking compounded versions of the blockbuster drugs. Even with Lilly’s recent shell-game with Zepbound, millions of patients have gotten used to the convenience of compounded GLP1s — drugs they will need to take for life. What will happen to them? 

This session will help answer those questions so you can be prepared to guide patients — and prescribers — through the challenging transition.

Our response to the op-ed in The Hill

Last week, The Hill published an editorial by Dr. Kenneth McCall titled “Fake, unsafe weight-loss drugs are a worsening public health dilemma” in which he makes unfounded claims about pharmacy compounding. Here’s the response from our CEO (submitted as a letter to the editor, yet to be published or acknowledged):

In his op-ed for The Hill, Dr. Kenneth McCall is right: Fake pharmacies and the counterfeit, untested substances they sell are a public health dilemma. I’d even call them a scourge. But McCall is careless when he lumps legitimate compounded drugs in with the sketchy stuff as if they are one and the same. 

I feel sure he knows that medications prepared for an individual patient in a state-licensed, state-inspected pharmacy pursuant to a prescription are required to adhere to the high standards of the U.S. Pharmacopeia, in addition to state and federal law and FDA guidance. Unfortunately, both Dr. McCall and the organization on whose board he serves, the Partnership for Safe Medicines, have relied on statements they’ve copied almost verbatim from drugmaker news releases that conflate legitimate compounding with illicit activity and are grossly misleading.

Perhaps that has something to do with the fact that those drugmakers in fact fund the Partnership for Safe Medicines. In any case, Dr. McCall’s piece disparages legitimate pharmacy compounding — an essential therapeutic practice in our healthcare system, and one that millions of patients depend on when an FDA-approved drug is not appropriate for their situation (in the judgment of a prescriber) or not currently accessible.

Let’s talk about that Lilly announcement

There’s been plenty of coverage of Eli Lilly’s announcement this week that it will sell vials of Zepbound directly to consumers at a discount. But the company seems to have left out a few important caveats, as STAT News pointed out. 

Lilly simultaneously raised the “discounted” price it offers people whose insurance doesn’t cover Zepbound from $550 to $650 a month. Oh, and those Zepbound vials? That’s only the starter dose. For people to continue to use it — as they have to — the only option is the (hard to find) injector pens at full price.

The media turns to APC

If you happened to read the Lilly/Zepbound story on CBS News, you might have noticed that the story quoted our CEO Scott Brunner, who called Lilly's move “great news for patients” — at least theoretically. 

"We'll be eager to see whether Lilly’s direct-to-patient approach actually works and how quickly FDA will judge that supply is once again sufficient to meet demand. It’s that calculation that will determine whether the drug comes off the shortage list,” APC CEO Scott Brunner said in a statement to CBS MoneyWatch.

Inside Health Policy also quoted Scott in its story about Lilly’s announcement: “It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

A new bronze corporate patron

A big welcome to Ro, APC’s newest tier-level corporate patron! Ro specializes in weight loss (selling both brand-name and compounded semaglutide) and sexual health — including our new favorite name for compounded tadalafil gummies, “Daily Rise.”

“The pharmacists at RO have been our PFM members for a while," said APC Business Development Chief Jason Dunn. “Now, we’re glad to have Ro as a Corporate Patron. We appreciate their support and we look forward to working with them.”

Check out Ro, folks, but also be sure to check out (and support) all of APC’s corporate patrons — and learn about becoming one yourself — right here. 

Next month

• September 16: APC Board of Directors Meeting
• September 17–18: Compounders on Capitol Hill (CCH) in Washington, D.C.
• September 17: APC Annual Meeting, Washington, D.C. (in conjunction with CCH)
• September 17: Legal Issues in Compounding Symposium, Washington, D.C. (in conjunction with CCH)
• September 23: EduCon Virtual Learning Series, Part III

This year

• October 14-17: ISTX24: PCCA International Seminar, Houston
• October 22: APC webinar with Pharmacists Mutual: Coverage, Claims, and Compounding: What You Need to Know About Your Liability Insurance
• November 15-17: Personalized Medicine Certification Course 1: Endocrinology in St. Pete Beach, Fla. 
• December 13: APC Board of Directors Meeting
• December 13-15: A4M Longevity Fest, Las Vegas

On demand

• APC's "The Ethical, Legal, and Regulatory Foundations of Pharmacy Compounding" 15-hour certificate course
• The FDA Compounding Quality Center of Excellence provides these self-guided online courses:
  • Aseptic Process Simulations (Media Fills)
  • Regulatory Framework for Human Compounding
  • Stability and Beyond-Use Dates

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