From APC's President...
It's been two weeks of high stakes, high stress, and high demand for pharmacy compounders
...... as COVID-19 has swept the country......
... as we've all adapted our business processes and physical layouts to maximize prevention while continuing to serve patients ...
... as we've suddenly found ourselves compounding more hand sanitizer - when we can source the ingredients - than we ever imagined we would, grateful for FDA easing restrictions to allow it ...
... as a very old drug has been touted as a possible treatment, resulting in its hoarding and shortage ...
... and as OTC and prescription drugs needed in COVID-19 treatment have gone into shortage, creating yet another need pharmacy compounders can meet if FDA will act to allow it ...
And it's just begun. By all indications, we're in for several more weeks of more and more and more of this. I can't decide if I'm more tired than energized or vice versa, but I'm definitely both, and I suspect you are, too.
Hang in there. It's times like this when we call on every bit of our training and passion - and add in come compassion - to help us be the servants and healthcare providers our communities need us to be. You have my gratitude for all you're doing and my prayers that you'll have the strength and resources to continue.
The past two weeks have been a whirlwind for APC, too, of course, as we've worked with our industry partners to alert Congress, FDA and others to the great need for compounders to be allowed to assist to the fullest degree in COVID-19 prevention and treatment. I'm so proud of the work your association is doing on your behalf. I hope you're seeing and hearing about it. I hope it's valuable to you.
Read on for FIVE BIG THINGS we think you should know about right now. And stay well - your community is counting on you.
Shawn Hodges, PharmD
President
shodges@innovationcompounding.com
UPCOMING:
April 9: Webinar - Hydroxychloroquine and its Potential in COVID-19 Treatment: A Briefing for Pharmacy Compounders
September 9 - 10: APC's Compounders on Capitol Hill (Washington, DC Fly-In)
October 2 - 3: Medisca's World Congress of Compounding in Las Vegas, Nev.
November 4 - 7: PCCA International Seminar in Houston, Tex.
1. Drug shortages aren't 'coming,' they're already here.
What APC and its partners anticipated in a March 27 letter to FDA - that many OTC and prescription drugs used in the treatment of COVID-19 were soon to go into shortage - has become a reality. Health systems have been hit hardest by the shortages of drugs used to place patients on ventilators. It's likely the shortages will only get worse.
For its part, FDA has in the past week added Midazolam and a version of Fentanyl, as well as the untested-but-highly-talked-about drug Hydroxychloroquine, to its shortage list. But the agency's actions thus far are not sufficient to the growing need.
Pharmacy compounders can help meet this need if FDA will allow it.
This week APC wrote to FDA's CDER Director Gail Bormel to reiterate our request in last week's letter to FDA asking that the agency immediately issue guidance providing enforcement discretion for pharmacists to compound products that are "essentially a copy" of an FDA-approved drug that FDA identifies may be or is anticipated to be, in shortage during this public health emergency.
We also provided additional documentation of the urgent need of hospitals across the country, and urged FDA to immediately announce it will " exercise enforcement discretion on the compounding of critical medications needed by hospitals and physician practices for office administration in the treatment of COVID-19 patients during this public health emergency when the drug is unavailable either in FDA-approved form or from an outsourcing facility and noted as such on the drug order. This could be done with the approval of state boards of pharmacy and other state health officials as needed to respond to the situation on the ground."
"FDA has acknowledged receipt of the communication," said APC President Shawn Hodges, "So for now we wait - and pull our hair out with frustration because compounders saw this coming. Had our requests to FDA been heeded, we could have been positioned two weeks ago to meet this great need. Once again, compounders are standing on the sidelines, ready to serve our patients during a crisis, waiting for the FDA."
2. Your patients expect you to KNOW.
Maybe Hydroxychloroquine will prove to be an appropriate treatment for COVID-19. Maybe it won't. But with all the attention it's receiving in the media right now, there's a good chance that you're being asked about it by patients or other healthcare professionals. They expect you to know.
That's why we're offering a webinar next Thursday on Hydroxychloroquine. It will include an update on the latest literature, just in time for those questions you're fielding. Think of it as a refresher as well as a briefing on recent studies and trials that may have bearing in the current debate about the drug - so that you'll feel more confident in understanding and answering questions about its current place in therapy.
Register here.
3. FDA gives compounders a hand on hand sanitizer
The double standard FDA created two weeks ago - in which certain firms were allowed under temporary FDA guidance to use food-grade alcohol for compounding hand sanitizer, while pharmacists were required to use only USP-grade alcohol - has been corrected. In a footnote to a guidance update last week , FDA said that that "alcohol derived from synthetic processes" can be used by pharmacists to make hand sanitizer "only if it meets USP or Food Chemical Codex grade." This past Monday, in a stakeholder conference call regarding hand sanitizers, FDA elaborated. APC tweeted about it the next morning:
4. Get your compounding news in real-time
APC's Compounding Connections is published every two weeks, but stuff happens a lot more frequently than that - stuff about compounding, stuff you need to know. That's why we post news, tips, and the occasional sarcastic quip in real-time, as it happens, on APC's social media accounts. Just pick one, and stay up-to-date:
Follow us on Twitter: @a4pcrx
Like us on Facebook: Alliance for Pharmacy Compounding or @a4pcrx
Following on LinkedIn: Alliance for Pharmacy Compounding
5. One COVID resource page to rule them all (sort of)
Several of our sister pharmacy associations have created COVID-19 resource pages for pharmacists, and they're all good. NCPA's is here (great store posters, by the way!). APhA's is here. But if forced to name a favorite, we'd point you to NASPA's 'From the States' page, at which, among other resources, you'll find:
- State-by-state details on special orders affecting pharmacy during this public health emergency.
- A hand sanitizer compounding page including links to all guidance documents.
- FDA fact sheets and state orders regarding Hydroxychloroquine, Chloroquine, and Azithromycin.
- Pharmacy organizations' joint policy recommendations to combat the COVID-19 pandemic
- Compilation of state actions affecting insurers, from the Commonwealth Fund.
- Health Insurer Responses, from America's Health Insurance Plans.
- National Governors Association's comprehensive look at state actions.
- National Council on State Legislatures' compilation of state legislation related to the pandemic.
- Pew Charitable Trust's visual collection of state actions.
Go. Search. Bookmark it. And tip your hat to our friends at NASPA.
Want to assure APC's continued success? Do these 3 things:
1. Help us grow our membership. If you're reading this, you're likely our member. Thank you. But are your pharmacy teammates members? If not, ASK THEM TO JOIN. If they enter the code NEWYEAR at www.a4pc.org/join before Feb. 15, they can save on their annual membership dues. Also, when it's time to renew your APC dues this year, do it timely.
2. Invest in One Fund. It fuels our entire advocacy operation. Last year, we fell short of our One Fund investment goal bigtime. That shortfall will affect what we can accomplish in 2020 on a range of issues, from the proposed animal compounding GFI to the USP appeals to bulks lists to legislation on dietary supplement monographs. Please invest in One Fund NOW and help us make-up this shortfall.
3. Help support members of Congress who think like you do about pharmacy compounding. Make an investment in COMP-PAC, our political action committee, to help make sure we're heard on issues that matter to your profession.
Five APC Benefits that will more than pay for your dues
We offer members-only discounts on a range of products and services that more than cover the cost of your annual APC dues. Here's the list and links:
- The APMS Patient Safety Organization (PSO), helps you put safety at the center of your pharmacy operations. Get a handle on the inherent risks in your pharmacy's workflow and discover opportunities for improvement in a legally protected environment. Find more information here.
- Get $500 off the cost of PCAB accreditation, the gold-standard certification for compounding pharmacies when you use code APC202.
- Save $200 on the registration for CBI's Compounding Compliance Conference. Details here.
- Get a no-cost, no obligation gap analysis of your business and liability insurance coverage via RiskAlert-Rx - a service specially designed to help APC member owners better understand risks of loss, plus you'll get step-by-step solutions to address any deficiencies.
- Get 10% off $500 or more of marketing services from Storey Marketing. (Valid one time per pharmacy owner.)
