From APC’s President

Please, sir, I want some more

Dear A4PC,

Getting permission isn't always easy

The following headline appeared on the front page of the April 7 Wall Street Journal: “Calls Grow to Abandon Rules Eased in the Pandemic”: There are people who want pre-Covid regulations — on, for example, alcohol served to outdoor diners and telehealth — gone for good.

Quoted in the article is Governor Mike Dunleavy of Alaska, who asks, "If a regulation needs to be suspended during a crisis, we have to ask ourselves, why was it there in the first place, and can we live without it?"

Two conflicting attitudes are evident in any policy debate concerning innovation and technology, and both focus on what Adam Thierer calls the "permission question." In his book Permissionless Innovation, Thierer explores the answers to that question and the subsequent effects on innovation and progress.

Must the creators of new technologies seek the blessing of public officials before they develop and deploy their innovations?

That depends on how you feel about new ideas and technologies … and risk-taking in general. There are a couple of ways to look it it.

The "precautionary principle": New innovations should be resisted until their developers can prove that they will not cause any harm to individuals, groups or cultural norms.

"Permissionless innovation": Experimentation with new technologies should be allowed to continue unabated; problems, if any develop, can be addressed later.

Mother, May I?

"Humans are allergic to change. They love to say, 'We've always done it this way.' I try to fight that. That's why I have a clock on my wall that runs counter-clockwise."

The quote "It's easier to ask forgiveness than it is to get permission," is attributed to Admiral Grace Hopper (although it has a long history), but I feel like it must have started with a pharmacist.

Pharmacists need permission to build our prescription departments the way we want. We need permission to stock different types of drugs. We need permission to ship into another state. We have been asking permission to get paid for many of the services we provide for years. Then came Covid-19, and many of the rules that confined pharmacies and pharmacists went away, leaving opportunities for those with the vision to seize them.

One such area of opportunity is telehealth, and APC will be hosting a webinar on April 13: “Pharmacy Fulfillment for Consumer-Focused Telehealth Platforms.”

Many compounding pharmacies have been tapped to provide "fulfillment" for certain digital, consumer-focused telehealth platforms. Under those business models, the companies use independent (and, frequently, compounding) pharmacies to fill and dispense prescriptions; those pharmacies are paid in cash, generally direct from the patients. But, of course, the precautionary principle prevails — there are legal issues to be aware of, especially when it comes to an on-line presence, e-commerce, and payment.

APC is doing more than hosting that webinar. Telehealth is booming thanks to the pandemic, and you can rest assured that your association is already hard at work confronting the issues pharmacists face. APC has already begun to have critical dialogue with several of the agencies creating roadblocks for our members.

We’ve also been working with our corporate partners at the Brown & Fortunato law firm, who have written a white paper that explains the issues compounding pharmacies have getting accreditation to fulfill online. (View and download it here.) It’s a perfect start for members preparing to navigate this new and exciting landscape.

Telehealth represents an amazing opportunity for us to bring our specialized training and preparations to an ever-growing patient population. And while APC does not believe you should have to ask permission to participate, we certainly don't want you to have to beg forgiveness.

Michael Blaire is APC’s president, but his day job is vice president for government and regulatory affairs at Wedgewood Pharmacy in Scottsdale, Arizona. You can reach him at mblaire@wedgewoodpharmacy.com.

This Week

A4PC, look for APC's Compounder Survey!

APC has launched its first-ever survey of compounders, in conjunction with the University of Mary Washington — canvassing more than 19,000 pharmacists, technicians, and others involved in pharmaceutical compounding.

The goal: The first comprehensive picture of the breadth and depth of compounding in the U.S.

Your answers will be crucial for informing policy makers, media, and even APC's advocacy efforts.

The 10-minute survey will collect data on practice areas, the scope of your compounding (and how that has changed), the size of your business, and similar areas, as well as basic demographics.

If you're a member of the compounding community, take the survey now!

Sneak video peek at the cBHT campaign

Part of APC's big media campaign to save compounded hormones are deeply moving testimonial videos — real patients' stories, read by professionals, to show how their lives have been improved. They're just one tactic in the multi-pronged campaign we're planning

Check out one of those videos right now:

But there's one little problem...

The videos are ready. The website, too. Ads — print and digital — are in the hopper. We’ve even got materials you can display in your pharmacy:

We raised $881,000 to create the content — to pay the models, the photographer, the videographer, and the designers.

But investments in the campaign have stalled. On the cusp of launching, we need the rest of our $1.5 million goal (about $619,000) to fund it.

If the funding stops, all this wonderful content sits gathering virtual dust.

That $819,000 came from only 15% of APC members and a handful of supportive vendors. We need you, the other 85%, to help. (Some of you must rely on compounded hormones for a good part of your business!)

If you haven't invested in this campaign — in, really, the future of your business — think about what restrictions on compounded hormone therapy could mean for you and your patients, and invest now. It takes only three minutes, and we need and appreciate your support … urgently.

ICYMI: Remember to help spread the word about the cBHT media campaign. We've got a great four-page brochure you can download and print to share with the vendors and prescribers you work with. It explains why compounded hormones are under threat, how that will hurt their patients, and how APC plans to protect it. And it urges them to contribute to the effort.

Three new resources for your grassroots advocacy

One of APC's 2021 priorities is to make more connections between compounding pharmacists and both legislators and the boards of pharmacy of all 50 states — one-on-one meetings, pharmacy tours, and positioning compounders as the go-to resource for questions related to pharmacy laws and regulations.

Working with attorney Stephen Snow and his team at Bendin, Sumrall, and Ladner, we've developed some new grassroots resources to help. Grab them below, or find them on A4PC.org/stateside.

APC's goal is to have 12 congressional visits hosted among its member pharmacies during the year. Visits are one of the best ways to build relationships and bring attention to the issues faced by the compounding community. Check out Hosting A Pharmacy Visit With Your State Or Federal Legislators and talk to us about scheduling one!

Reminder: Briefing on PCF's independent NASEM analysis

The independent analysis of the NASEM cBHT report commissioned by the Pharmacy Compounding Foundation will be released in the next couple of weeks. It should serve as a counterweight to the deeply flawed, FDA-manipulated NASEM report.

The foundation is holding a live briefing to roll out that analysis, explain our next steps, and answer any questions. That's on Tuesday, April 20 at 3:00pm EDT via Zoom. It will be open to all.