The voice for pharmacy compounding • May 15, 2020
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Enjoy our latest edition. Send your suggestions and questions to
info@a4pc.org
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Shawn Hodges
APC President
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This Wednesday the stars aligned: Two major documents were released, each of which will likely have profound implications for compounding.
The first was the FDA-funded NASEM study of compounded pain creams. The second was 20 years in the making: FDA's final MOU with states regarding interstate shipments of compounded drugs.
Both have been APC priorities, and both to some degree reflect our input. But that doesn't mean all is right with either one. Please take time to read (in "5 BIG THINGS YOU NEED TO KNOW RIGHT NOW") about the good, the bad, and the ugly of both — and stay tuned as APC determines best next steps.
EduCon rocks!
I want to thank our APC team for pulling off a whopping success with our EduCon2020 Virtual two weekends ago. The evals are in and they're overwhelmingly positive — attendees even said APC should consider doing more virtual events. For those of you who missed it,
I need to ask, what on earth were you thinking? we're making available three parts of the conference I suspect will interest you:
- Our 2020 'State of the Alliance' presentation. Give a look/listen to what your association has accomplished over the past year, what lies ahead, and how we're confronting challenges for you.
- FDA Center for Veterinary Medicine Director Dr. Stephen Solomon's presentation on FDA's draft animal compounding GFI #256. It's a thorough overview of FDA's thinking on the draft GFI, and though we don't see eye-to-eye on every point, it's a helpful presentation.
- APC's first-ever Virtual Expo. Don't ask how you do a trade show virtually. Just click the link and see for yourself. And please give your business to the Corporate Patrons and exhibitors represented there. The virtual expo will remain open on the APC website through the end of this year.
All three of these are definitely worth your time.
$25 to help us grow
Finally: If you read this column consistently, you know that growing APC's membership is important for the profession, and it's a priority for me as your president. To entice you to have your pharmacy team join APC, we'll give them $25 off an annual membership — but only through the end of May. Go to
A4PC.org/join and enter code
APC2020 to get the discount. Please?!
Thanks for your support for APC.
Read on about the 5 BIG THINGS YOU NEED TO KNOW RIGHT NOW....
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2020 OSHA Training:
Bloodborne Pathogens
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1.
FDA finally releases “final” MOU, and it’s flawed
In states that sign the MOU, pharmacies that ship more than 50 percent of their compounded drugs out of state will trigger state investigation and reporting requirements and the state board of pharmacy will be required to report adverse events to the FDA. Pharmacies in states that don’t sign the MOU will be prohibited from distributing more than five percent of their compounded drugs out of state.
Obviously, a five percent cap on out-of-state shipment of compounded preparations would have a profound chilling effect on patient access to certain compounded drugs. That’s why, over the past two decades, APC has urged FDA to make essential changes to the previous drafts of the MOU. Our aim has been twofold: to assure, first, that the lawful and proper provision of compounded meds to patients,
pursuant to a prescription and regardless of their state of residence
, is preserved; and second, that the final MOU is one that states can live with and will actually sign.
This latest version of the MOU incorporates some of the suggestions APC and other stakeholders made in relation to the requirements on states, and those changes may serve has helpful inducements for states to sign the MOU.
However, the final MOU still redefines the key term “distribution” to include the patient-specific dispensing of compounded drugs –
in other words, applying the term
distribution
to include traditional dispensing of medications pursuant to a patient-specific prescription, an area appropriately regulated by state boards of pharmacy under state law.
This redefining of a key term is inconsistent not only with the plain statutory language of the Food, Drug & Cosmetic Act, but with the definition of the term “distribution” in every other appertaining federal law. Concern about that inconsistency has been raised in multiple letters from members of Congress to the FDA, statements in the congressional record, appropriations report language directives, and the overwhelming consensus of stakeholder input to the agency on this issue.
In states that choose for whatever reason not to sign the MOU, pharmacies will be limited to shipping no more than five percent of ALL compounded drugs (
including
those dispensed with a prescription) out of state. Enforcement of a five percent cap on that kind of traditional, patient-specific dispensing – as opposed to applying the cap only to distributions of drugs in larger quantities without a prescription – could deprive patients of needed medications. Moreover, it’s simply not supported by the statute and will undoubtedly trigger lengthy and expensive litigation, tying up the issue in the courts for a long time.
It’s particularly disappointing given the lengths APC and other stakeholders went to in providing FDA suggestions for a very narrow, limited definition of “distribution” for the purposes of the MOU that would meet the statute’s intent, satisfy FDA’s information needs, and avoid legal action.
The timing of the release of this final MOU is curious given temporary guidance FDA issued on April 20 that allows 503A pharmacies to actually
distribute
(without a patient-specific prescription) certain compounded COVID-19 treatment drugs to hospitals when those drugs are unavailable commercially or from 503B outsourcing facilities.
APC is studying the MOU and will continue working with our allies in Congress and other pharmacy stakeholders and organizations representing providers and patients who rely on compounded drugs to effect policy outcomes that are both safe and protect patient access to the medicines they need.
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2. NASEM releases compounded pain creams report
The background: "The FDA has made clear that it has concerns with compounded pain creams," explained APC CEO Scott Brunner, "so, considering that the FDA paid for this report, we've always felt it was likely a foregone conclusion that it would reflect FDA's position."
Now that the the report is now out, we can see that its conclusions, while not surprising, are also to some extent, well, inconclusive.
NASEM's overall conclusions:
- There is not enough information "to conclusively support conclusions regarding safety and risks" of compounded pain creams, nor about the risk of individual APIs when absorbed.
- That lack of evidence "gives rise to a substantial public health concern" and HHS should focus on those APIs that "enter the bloodstream and act systemically within the body."
That said, the study panel had these recommendations:
- Use "utmost caution" when prescribing or dispensing compounded pain creams.
- Do more research on the safety and efficacy of the ingredients, especially when absorbed through the skin.
- State boards of pharmacy should require additional training for clinicians (especially pain specialists), as well as pharmacy compounders.
- The FDA, possibly with USP, should develop safety tests for the APIs and excipients being used.
- States should increase their oversight of the use of these creams.
"Yes, there is clearly a scarcity of research on the effectiveness of compounded pain creams," agreed APC President Shawn Hodges. So we wholeheartedly support the study’s call for additional studies — double-blind, placebo-controlled clinical studies. If the FDA is going to take a position, it should do so with verifiable, objective data."
And in
a media statement released Wednesday, APC's Brunner pointed out some obvious concerns with the report: First, it failed to consider the relative risks of topical pain gels — for example, compared to treatment options such as narcotics. Especially for patients with chronic pain, those risks are negligible in comparison. "We're facing an opioid crisis," he said, "not an analgesic-cream crisis."
Secondly, the study treats patients as faceless data points; it doesn't consider the critical measure: outcomes. Patient-reported results are an integral and appropriate component of any report on the effectiveness of a drug.
You can read a short PowerPoint-style overview of the NASEM report
here (1.6 MB PDF) or the full, 353-page report
here (5.4 MB PDF).
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3. Jensen to chair USP expert committee
APC member Brenda Jensen was elected chairman of USP’s Compounding Expert Committee at last week’s USP Congress.
"We’re delighted with her election," said APC CEO Scott Brunner. "Brenda’s extraordinary expertise and in-pharmacy experience will serve USP well. I’m glad she’ll be there to preside as the CEC confronts some critical issues related to the safety, accessibility and affordability of compounded medications."
A U.S. Air Force veteran, Brenda's pharmacy career began during her service in 1984. Since then, she's spent time in both retail and hospital pharmacies, started two pharmacies — one compounding-only in 2001, and a community pharmacy in 2007. Then in 2011 she launched Compounding Consultants to help fellow compounders earn their accreditation. Today she lives in eastern South Dakota.
"I'm looking forward to continuing the great work that USP has been doing on behalf of compounders and all pharmacists," she said.
One of the issues the CEC will be considering is beyond-use dates specified in the proposed new USP chapters <795> and <797>. As a result of a successful 2019 appeal by APC and others, that issue was remanded to CEC by USP's Appeal Board this past January.
"We look forward to a renewed process that is open, transparent and balanced," Brunner said.
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4. Animal compounding GFI remains high on radar
Although Covid-19 has stolen much of the limelight lately, FDA’s draft GFI #256 on animal compounding remains an APC concern and priority. As you’ll recall, that draft GFI would have FDA regulate veterinary medicine and compounding in a way it never has — and in a way, frankly, we don't believe statute permits.
In short, GFI #256 would severely limit how compounders could prepare veterinary medications — even for individual patients — by limiting the use of bulk API in favor of FDA-approved commercially available finished drugs.
APC is acutely aware of the danger this would pose to veterinarians, pharmacies, and pets. There are issues of potency accuracy, of medication acquisition, of preparing accurate dosages for a broad range of patients ... not to mention the question of whether FDA even has the statutory authority to intervene.
Because of the Covid-19 pandemic and the strain it has put on pharmacists and other healthcare workers, APC wrote last week to Dr. Steven Solomon, director of the FDA's Center for Veterinary Medicine,
asking for a 180-day extension of the comment period on Draft GFI #256 until December 16, 2020.
Dr. Solomon had been kind enough to participate in EduCon Virtual —
you can view his presentation here — so our letter included several follow-up questions from members, covering topics including the Index of Legally Marketed Unapproved New Animal Drugs, clarification of what the FDA considers acceptable rationale for using bulk API, concerns about pharmacies obtaining bulk drugs, and more.
With the issue far from settled, APC will continue to oppose the draft GFI and to work with veterinarians and pet owners to bring concerns about GFI #256 to FDA and Congress.
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5. The foundation is ready (but it needs your help)
Let's cut right to the chase: The Pharmacy Compounding Foundation needs your help to ensure a successful future for compounding.
It's been an unprecedented few months for the healthcare profession, especially concerning two of the foundation's priorities, education and the value of pharmacy compounding.
Please, give to the foundation now, when it's needed most. One time or ongoing, you can contribute to the foundation's mission at
A4PC.org/foundation.
Getting the word out
The emergence of the Covid-19 pandemic has upended the lives of every healthcare worker and patient, and it's also shown the critical need for compounding pharmacy as shortages and hoarding strain the pharmaceutical supply chain.
At the same time, over the past few years — fairly or not — compounding's reputation has taken a hit. We cannot allow a few bad actors, no matter how visible, to continue to cast a shadow over an entire profession during this crisis.
That is the message we need the public to hear: Pharmacy compounders, now more than ever, are a critical part of the healthcare system. That's why the foundation is interested in supporting a consumer focused public relations effort to send that message — to help the public understand the important role pharmacy compounding plays.
Supporting future compounders
The coronavirus has also wreaked havoc on the lives of pharmacy students, with classes and programs postponed, moved online, or outright cancelled. Today and when this crisis has passed, those students will need our support.
The foundation continues to help cultivate those future pharmacists and pharmacy technicians with scholarships, grants, and educational opportunities. And we're looking ahead even farther to working with state and national pharmacy associations to provide compounding-focused education.
Reaching these goals is only possible thanks to members who share their love for pharmacy compounding. If you haven't already, please join them — your contribution will help assure that we can continue our work on those issues and assure compounding’s future.
A donation of just $50 or $100 can be enough to make a difference — even better, make it ongoing. Contribute to the future of compounding at
A4PC.org/foundation today — the foundation, the students, and your profession will be grateful.
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