The voice for pharmacy compounding | April 17, 2020
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From APC's President...
Yesterday, on a CompPAC-sponsored Town Hall call, I listened as APC member Diana Harshbarger explained why she was running for Congress in Tennessee's First District. Diana has deep roots in compounding and IACP and made an eloquent and impassioned case for her candidacy - including why pharmacy compounders need an ally like her in Congress.
The primary election is in August, and she's doing well so far in a race whose winner will almost certainly be the next member of Congress from that strongly Republican district.
Diana Harshbarger has the grit to win the race.
I couldn't help but be proud as I listened Diana - proud of my profession for raising up such a leader as Diana, and proud of Diana for the confidence and courage it takes to run for public office these days. I'm also proud of the announcement on yesterday's call that CompPAC, APC's political action committee, will support Diana with a $5,000 contribution.
As Diana said on the call, "Money is the mother's milk of politics." She needs more than just CompPAC support to win. She needs your personal support, too. She needs you to contribute to her campaign, to put your money where your mouth is and help send one of our own to Congress.
It's been another crazy, anxious, awful week of this pandemic. I can't say it enough: Thank you for all you're doing to take care of your patients and community. Please take care of yourself and your team as best you can.
Read on for
FIVE BIG THINGS pharmacy compounders need to know about right now. And stay connected with us on social media for the latest, greatest. Our handle is @a4pcrx.
Shawn Hodges, PharmD
President
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1. About those hospitals needing shortage drugs for COVID patients ...
It's a hard story to miss: Many hospitals across America continue to be unable to find drugs essential for treating patients with COVID19.
Axios
this week reported that only 53% of those scripts for ventilator and other COVID treatment meds are being filled. Ideally, 503Bs should be meeting this need, but some hospitals can't find outsourcing facilities to provide the medication.
APC is working on two temporary ways to address this dire situation.
"W
e
recognize and respect that the FDA's preferred solution to the current shortage situation is for health systems to source the drugs from 503Bs," said APC President Shawn Hodges. "But clearly, many are unable to do so - either they're unable to find a B or the Bs they're finding don't have the needed drugs in production."
To address that first issue - hospitals' inability to know which 503Bs are making which drugs - APC is working on an online solution to match health systems with specific needs to a 503B that is making the needed drug - and to do it quickly. "We hope to have more to say about that soon," said Hodges. "For now, we concur that 503Bs should be the first source for distributions of COVID-19 meds that are in shortage, and we want to help connect the two entities."
But there remain situations in which a hospital cannot find a 503B to meet its urgent need for COVID treatment drugs, Hodges said. "Remember, the first priority here must be the patient, and hospitals must be able to access essential drugs. In situations in which 503Bs are not producing the shortage drug, 503As must be allowed to meet the need, within strict guardrails to ensure no patient harm."
Three weeks ago, APC anticipated this need and urged FDA to issue temporary guidance announcing enforcement discretion to allow certain certain 503A pharmacies meet this need under the "Rx Lookback" model. In Rx Lookback
, a
patient specific prescription information is provided by the hospital to the 503A pharmacy within seven days after receipt of the drug. That model can and should serve as a template for states. "It is tightly constrained, so that 503Bs remain the first go-to source for the medications," said Hodges.
The model is already being employed in one state to confront current shortages. Until 503Bs can meet the need, 503A compounding pharmacies in that state that are accustomed to preparing sterile medications (intravenous or IV medicine) can compound and provide these products to health systems in that state, adhering to USP Standards. By compounding under USP, certain 503As can provide hospitals with high quality products in short order. State regulators there, as well as the DEA, have been instrumental in facilitating production of those shortage drugs within the parameters of state and federal law.
APC continues to encourage FDA to act on this common-sense proposal. At the same time, we're reaching out to state boards of pharmacy to urge them to consider Rx Lookback.
"We urge the FDA to pay attention. The goal is to fill the gap until the drug manufacturers have ramped up production," said Hodges. "Without it, patients are at risk."
2. EduCon2020 goes VIRTUAL
It's just-in-time training...for times just like these!
APC's Denver event was cancelled, so now EduCon2020 is coming to you as a VIRTUAL conference featuring CE sessions focused on issues you're confronting here and now ...
* The latest on temporary regulatory guidance for compounding during the pandemic.
* Holding your team together and keeping up morale in a crisis.
* Best practices for compounding from FDA's Drug Shortage List.
* Looking ahead to compounding after COVID-19.
* ... and much more.
EduCon VIRTUAL is set for May 2 and 3, 2020, and will feature:
- Seven live online CE sessions spread over two afternoons.
- APC's State of the Alliance Report and 2020 General Membership Meeting.
- A presentation from FDA Center for Veterinary Medicine Director Dr. Steven Solomon, DVM, on FDA's draft guidance on animal compounding.
- A virtual trade expo featuring APC's Tier-Level Corporate Patrons and other vendors of pharmacy compounding products and services.
- All the best practices, tips and insights to help you serve your patients well during and beyond this public health crisis.
With an easy-to-use online platform, over the course of two days we will bring multiple speakers and content right to your store, office or home.
This experience will allow us to engage as a community in a new way. If you are unable to attend a live session, speaker presentations and recordings will be available to you after the virtual conference - so there's no pressure to join us for every minute of the experience.
Here's how to register:
- If you were already registered for APC's cancelled Denver event in April, CLICK HERE to let us know how you would like to proceed.
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If you are a new registrant, not previously registered for APC's Denver event,CLICK HERE.
3. APC launches HCG Bulletin Board to assist physicians
With dermatologists and rheumatologists having trouble sourcing HCQ for lupus and rheumatoid arthritis patients, APC this week launched an HCQ Bulletin Board to connect compounders who have HCQ in stock with physicians who need it for their lupus and rheumatoid arthritis patients.
Submissions to the bulletin board are time-stamped, so physicians seeking HCQ will know the currency of the info submitted. When submitting, compounders must also indicate the states in which they're licensed. APC is providing access to the resource to members of the American Academy of Dermatology and American Rheumatology Association. It's up to individual pharmacies to post to the bulletin board whenever they have a supply of HCQ tablets or API.
The HCQ Bulletin Board page is not searchable, so please note and bookmark this submission link:
https://a4pc.org/hcqform
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Please participate in this important initiative. It's just another way compounders are coming through for communities in crisis.
4. USP issues COVID-19 compounding recs; seeks comments on draft HCQ monograph
USP recently issued "Operational Considerations for Sterile Compounding During COVID-19 Pandemic,"
which supports risk-based enforcement discretion of compounding standards. The document addresses the assignment of beyond-use dates, considerations for certification of engineering controls, and recommendations for facility cleaning and disinfecting when someone is sick. APC is analyzing the recommendations related to risk-based enforcement on BUDs in particular, in light of our earlier concerns about shortened BUDS in the new USP <795> and <797> chapters last year.
In addition, USP has made a Draft Compounded Preparations Monograph
a #Hydroxychloroquine Sulfate Compounded Oral Suspension available for public comment
through July 31, 2020.
APC supports this USP compounded preparation monograph and will be commenting to USP to that effect.
5. FDA issues emergency PPE guidance
Of particular note: As a strategy for reducing risk of microbial proliferation in a potentially contaminated product when not using standard PPE, the FDA guidance stipulates utilizing the following beyond use dates: 24 hours for products stored at room temperature; 3 days for products stored refrigerated; and 45 days for frozen products.
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