The voice for pharmacy compounding | March 20, 2020
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Enjoy our latest edition. Send your suggestions and questions to
info@a4pc.org
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From APC's President...
With so much going on, this edition of Compounding Connections is chock full of info about what APC is doing to enable you to serve your patients, both during this public health emergency and beyond it.
Quick reminders:
- Please renew your APC membership promptly and save us the added effort of reaching out to you multiple times. And while you're at it, add your technicians as members, too! Do it online here.
- Support OneFund. It fuels our entire advocacy operation. Goal this year is $200,000. We've already raised just north of $50,000. Thanks to those leaders who've already invested. You can be a role model, too. Make your investment here.
- If you haven't already, please submit comments to FDA on GFI #256, related to animal compounding. We've made it easy to comment here.
Please remember to take care of yourself during this pandemic, because your community is counting on you. Thanks for all you do!
Now read on for the latest on hand sanitizer, the hunt for Hydroxychloroquine API and more...
President
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UPCOMING:
September 9 - 10:
APC's Compounders on Capitol Hill (Washington, DC Fly-In)
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I wanna hold your hand (sanitizer)...
Did you ever imagine something as mundane as hand sanitizer could become such a big deal? It's been an eventful week or so in terms of compounders' ability to meet demand in the current hand sanitizer shortage. Here's a run-down:
- Last week, with the help of Congressman Buddy Carter (GA-1), APC reached out to FDA urging them to allow pharmacy compounders to prepare hand sanitizers to meet demand in the current shortage.
- Saturday morning, FDA released a guidance document doing just that, and we alerted you.
- Within hours, we began hearing this from APC members:
- So on Monday, we urged our members not to let a good crisis go to waste, and offered a suggestion for engaging news media - plus a few caveats - on the hand sanitizer ingredient shortage issue.
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APC's CEO Scott Brunner also emailed FDA's Dr. Gail Bormel on Monday to alert her about the need for additional clarity and flexibility in what FDA would allow related to compounding of hand sanitizers. Despite FDA's March 14 guidance, he wrote, "
challenges remain which, if not addressed timely by FDA, will limit the effectiveness of FDA's temporary guidance and pharmacy compounders' ability to be helpful in COVID-19 prevention efforts."
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That same day, FDA created an email address for compounders to submit questions regarding prep of hand sanitizers: compoundingpolicy@fda.hhs.gov.
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On Wednesday, in response to FDA's March 14 guidance on alcohol-based gels, USP's Compounding Expert Committee issued advice to boards to use risk-based enforcement discretion on USP standards. It also issued instructions on how sanitizer can be compounded safely, as well as guidance on PPE shortages:
(Yes, USP's guidance on hand sanitizers is confusing. Section 503A of the Drug Quality & Security Act only allows USP/NF grade for API, and the March 14 FDA guidance allowing compounders to prepare hand sanitizers requires all ingredients to be USP grade and does not permit deviations. That means USP's formula #3 in its guidance does not comply with the March 14 FDA guidance. So what to do? Speculated one APC member: "
I really don't see anyone coming after pharmacy for making hand sanitizer as long as it is an effective hand sanitizer. FDA has a lot bigger issues right now than me making hand sanitizer." That's just a quote, not advice, mind you.
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We're currently awaiting a response from FDA to our Monday and Wednesday communications.
Is a shortage of hydroxychloroquine the next crisis?
Data from Asia and Europe suggests that hydroxychloroquine may be a useful agent in the fight against COVID-19. It is being discussed in evening news programs and was mentioned by President Trump during an afternoon press conference on March 19. We are hearing that the commercial tablets and bulk API are all on back order through the middle of April.
C
ompounders can be instrumental in supporting
patient access to hydroxychloroquine, provided we can source the API, which right now is difficult.
APC is working with our industry partners to create a roadmap for addressing this issue, and we'll be reaching out to FDA soon. Stay tuned for more info - and if you have ideas or intel, contact scott@a4pc.org.
COVID-19 resources for pharmacies
Check your state board(s) of pharmacy websites for jurisdiction-specific information about the COVID-19 outbreak and for emergency information for pharmacists and other health care providers. In addition, the American Pharmacists Association has created a COVID-19 resource center for pharmacists, which includes the latest information from federal agencies and a decision tree document that helps pharmacists talk to patients with various levels of exposure to COVID-19.
Pharmacy Times talks to APC's Hodges, Burch about COVID-19 prep
Cuellar and Moolenaar question Hahn on MOU
In a March 11 congressional hearing, FDA Commissioner Stephen Hahn, M.D., provided new insight into FDA's current thinking on the long-awaited MOU on out-of-state shipments of compounded medications. In response to questions from House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration members Rep. Henry Cuellar (TX) and Rep. John Moolenaar (MI), Hahn said FDA was working on balancing the safety of compounding but not making it overly burdensome on states. "We want as many states as possible to sign this, and we understand access to compounded drugs is critical to some patients - and we do not want to deny that access - so finding the right balance between safety and getting those drugs to those patients will be important," Hahn said.
Hahn emphasized that FDA was aiming for a "balanced approach" to the MOU:
"We recognize that some patients rely on compounding specialized approach to get the medicines they need, on the other hand we are aware of safety issues and outbreaks that have occurred in the past we want to ensure supply and make sure it's safe as well is really important .... We are trying to streamline the processes around this to make it easier for compounders."
We're grateful to Congressmen Cuellar and Moolenaar for their support for pharmacy compounding and the patients you serve.
Postponed EduCon likely to be combined with CCH in September
We're exploring the possibility of combining our EduCon2020 conference with APC's Compounders on Capitol Hill event scheduled for the first week of September at the Omni Shoreham Hotel in Washington, DC. For now, we ask for your patience as we work out details. We hope to be able to share a firm plan within the next two or three weeks.
FDA suspends domestic inspections
Yesterday, FDA
announced
that in light of the COVID-19 threat, the agency is temporarily postponing all routine domestic facility inspections. Read more here.
How much is it worth to you?
APC joins congressional NHIA letter on home infusion
Our upcoming CE webinars are perfect for social distancing
We've got three great CE webinars coming up in April and May.
Get registered and put these on your calendar:
April 14, 2020
1:00 - 2:00 pm CST
The Office of Civil Rights of the Department of Health and Human Services implemented Section 1557 of the ACA in 2016 that prohibits discrimination based on race, color, national origin, gender, sex (including sexual identity and sexual expression), age, or disability in federally funded health care programs. It also requires that providers, including pharmacies, must take reasonable steps to provide meaningful access to individuals with Limited English Proficiency and those with disabilities. And, it gives patients the right to civil litigation (they can sue you!) if they are discriminated against or if you fail to comply.
Does this apply to your pharmacy? Yes
, if you accept payments from government programs (including Medicare Parts A, C, and D, Medicaid, TriCare, Military, etc.) for goods or services. In this program we will review the background and key provisions of Section 1557 and provide examples of how it applies to your pharmacy, what is needed for implementation, and the consequences for noncompliance. Register for this webinar and get compliant!
May 5, 2020
1:00 - 2:00 pm CST
Reduce uncertainty in your use of peptides in the treatment of various medical conditions, and help bring about improved patient care & quality of life for the patient.
May 12, 2020
1:00 - 2:00 pm CST
We'll dissect and discuss the FDA 'Essentially a Copy' Guidance Document for 503A pharmacies, as well as how this applies to the compounding pharmacy and provider. We'll also address best practice solutions for proper documentation and run through multiple scenarios involving compounds, with appropriate action steps noted. Join us, and get tips on how to best approach providers and achieve positive collaboration to ensure continued patient care.
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These APC partners will keep you out of trouble (and save you money!)
We offer members-only discounts on a range of products and services that can improve your practice and 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.)
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