If APC had a tattoo on its bicep — if we had a bicep, I mean — it might well read “Consult legal counsel.” It’s what we advise pretty much every time we answer a member question about this or that compounding practice, every time we release a best practice document, every time we share info with our members. |
 |
 |
APC sent a letter to the New Mexico Board of Pharmacy this week commenting on its proposed amendments that would align the state with USP (good), but would also require that pharmacists ensure all flavors are inert (yikes). Our letter raises the concern that the flavoring requirement puts an unrealistic burden on pharmacists.
The APC Board of Directors has voted to name Gina Besteman (previously vice president) the board chair-elect after the resignation of Michelle Moser from the position. Besteman will assume the chair in January 2025.
In addition, the board essentially ‘moved up’ by a year everyone in the line of succession.
You can view the updated board webpage, with headshots, here.
Earlier this week APC received a letter from the FDA explaining the agency’s concerns regarding dosing and patient usage of compounded semaglutide and tirzepatide.
The letter brings up an issue (actually three related issues) that have come up in the FDA’s analysis of reported adverse events related to compounded GLP-1s. We’re not talking about pop-up fake pharmacies — these were dispensed by state-licensed pharmacies.
Granted, the issues the FDA raised relate to prescribing errors, but obviously pharmacists have a critical role to play in counseling patients on dosing — especially in a day and age when some of those patients are getting guidance on their GLP-1 drugs from social media. As APC CEO Scott Brunner put it, “That’s just dangerous.”
“Pharmacists have an obligation when they see a dosing error in a prescription to contact the prescriber and alert them to the problem,” Brunner said. “And of course they can and should educate patients about proper dosing. Clearly that’s particularly important in these cases.”
In the next few weeks, APC will be issuing a guide to GLP-1 best practices that will provide more detailed information for compounding pharmacists. Until then, keep in mind those three issues the FDA outlined. Urge your patients to listen to your guidance, and even intervene with prescribers when possible.
As the final gatekeepers of patient health and safety, remember that it’s your duty to stand up and speak out.
On Tuesday, the Federal Trade Commission released a scathing, two-years-in-the-making report about PBMs — a report that concluded, “This vertically integrated and concentrated market structure has allowed PBMs to profit at the expense of patients and independent pharmacists.”
Then on Wednesday, the agency followed up, saying it’s going to sue the biggest PBMs(Caremark, Express Scripts, and OptumRx) over their tactics for negotiating prices for drugs including insulin. In case you missed it, that report didn’t pull punches:
“[PBMs’ power] can have dire consequences, with nearly 30 percent of Americans surveyed reporting rationing or even skipping doses of their prescribed medicines due to high costs.”
The interim report also finds that PBMs hold substantial influence over independent pharmacies by imposing unfair, arbitrary, and harmful contractual terms that can impact independent pharmacies’ ability to stay in business and serve their communities.
The lawsuit news was breaking at press time, so there isn’t much detail yet. Still, the spectre of the suit is good news in itself.
The latest of APC’s new regional meetings is coming to LA/Anaheim on August 8 at the Hotel Fera Anaheim. It’s an evening and dinner where you’ll get two hours of live CE, a briefing on current compounding issues, and the chance to network with compounders in your area. Plus the food is great — and it’s all for only $25 thanks to a generous grant from PCCA.
We’ll be covering the benefits of low-dose naltrexone (learn the latest on dosing, safety, science and physiology) and restoring thyroid balance (including the latest on compounding with thyroid APls). Click here for details and to sign up.
Several members have contacted us about a story that ran on NPR’s Morning Edition about a pharmacy in Texas that compounded the chemical used for lethal injections. In the story, Bianca Tylek, executive director of a nonprofit that advocates against exploitation of prisoners, took the opportunity to attack compounding pharmacies in general with several unfounded and frankly inflammatory comments that went unquestioned by the host.
As with other media, APC is reaching out to NPR to provide a more accurate and nuanced picture of pharmacy compounding. In particular, explaining that the reason states are turning to compounding pharmacies is because the manufacturers of the FDA-approved drugs used in lethal injections refuse to sell to states for lethal injection. If the states could get the drugs from the manufacturers, they would, but they can’t. As awful as the situation is, states then turn to pharmacies that have expertise in preparing drugs. That’s a compounding pharmacy.
We also have an official statement on compounding drugs to be used in executions. Read it here.
We’ve been bugging the California Board of Pharmacy (politely!) for a while, trying to get a statement on its position and enforcement posture regarding the compounding of FDA-approved drugs that are currently in shortage. There has been some confusion — mixed messages, you might say — coming out of the Golden State regarding how the BoP views GLP-1 compounding, and we wanted some official clarification.
Good things, apparently, come to those who wait. In this case, it’s a response from the board in a letter last week saying that, “In general, the Board does try to align with FDA when possible,” and also reminding us that compounding pharmacies “must comply with a myriad of state and federal laws.” The bottom line, though — and our take on the letter (you can read it here) — is that the CA BoP’s position on GLP-1 compounding is consistent with that of FDA.
APC will soon be releasing a best practices document related to shortage drug compounding, including GLP-1s, that tracks to law, FDA guidance, and USP standards … and also recommends certain testing and other measures that go beyond those standards. Stay tuned.
The Mamas and the Papas said you can’t trust Mondays, but that’s not always true.
You can count on two things happening today, July 15. Whether you take advantage of them is up to you — but I hope you do.
Today is the last day to get early-bird registration rates for APC’s Compounders on Capitol Hill 2024. Come tomorrow, you’ll pay more to register — and boy, do we need you to register. Among issues we’ll be discussing in Hill visits with members of Congress are:
It’s 24 hours in Washington, DC that can make a big difference for your practice and patients. You can register now or later, but do it now and you’ll save money.
• • •
This evening is the first live session of EduCon 2024, APC’s three-part ethical compounding webinar series. It’s a total of six CE hours via three webinars over three months. And it’s great practical training for your team. Monday’s topic: Ketamine and GLP-1 compounding best practices with APC’s Tenille Davis. You can attend live or take the session on your own schedule. But you have to be registered to do either one. So get going.
Every other day of the week is fine, yeah. But you can trust that if you register for these two today, you’ll be ahead of the game.
Bah-da bah-da-da-da.
—Scott
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.
FOLLOW US
