Share your prescriber list (pretty please‽)

APC is working on a lot of fronts, and there’s a large group of people who can not only help our efforts, but benefit from them as well: prescribers. Simply put, we want to reach out to more of them — to engage and educate them, and, of course, to ask for their support.

We need your help to reach them. In short, we would like you to send us, confidentially, of course, a list of the prescribers you work with.

We will not sell or share this information in any way — it is solely for APC to use to get support from prescribing practitioners and clinics. (For the legal details of this, please read the full confidentiality statement.)

We understand that different record-keeping systems output their data differently, so we aren’t picky. The perfect format would be an Excel or CSV spreadsheet that includes the following information:

Simply email the file to info@a4pc.org (and note in the subject line that it’s a prescriber listing).

Thank you for your help. The more prescribers we can reach, the stronger the association becomes, and the more we can accomplish for you and your patients.

Wanted: cBHT bloggers — er, columnists

We’re looking for expert voices about cBHT — folks with some solid insight into the use of compounded hormones — to write columns on compounding.com. To be clear, this is more than just discussing the big picture, or expressing concern about potential FDA action (we’ve got that part covered). We want expert opinion, first-hand testimonials, and a professional voice that will resonate with patients and policy makers.

If you’ve got a flair for writing and making your case, we would love to have you write — once, occasionally, or even regularly — on compounding.com.

Applying is informal: Just drop a message to Scott Brunner at scott@a4pc.org, make your case, and share something you’ve written.

FDA announces June PCAC meeting

FDA will be holding a virtual meeting of its Pharmacy Compounding Advisory Committee, open to the public, on Wednesday, June 9, 2021, from 10:00 am to 5:05 pm EDT.

Agenda: “The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin.” It will also discuss adding neomycin sulfate to the Withdrawn or Removed List.

You can find more information on the announcement page, and you can submit comments on the meeting (by June 8, 2021) — follow the instructions on Regulations.gov.

APC will be developing input for the committee on at least two of the nominated substances. If you have suggestions, please direct them to scott@a4pc.org.

Yet another reminder: How to save cBHT

Learn the threat to compounded hormones. Find out more at compounding.com about the bad science in the now-debunked NASEM report.

Recruit your patients and prescribers to help save cBHT. Explain the issue and direct them to compounding.com where they can share their stories — stories that can make a difference with policy makers. (We’ve got the members-only tools to help you reach out at A4PC.org/cbhttools.)

Give to save cBHT. Saving compounded hormone therapy is the biggest — and most expensive — initiative in APC’s history. We are still well short of raising the funds needed to place the targeted ads we’ve created across the country. Help us fund this effort by contributing at A4PC.org/cbhtcampaign.

Together is how we’re going to save compounded hormone therapy!

The survey is over, and we have a winner (besides APC)

Congratulations to Nira Nikunj Kadakia, assistant professor of teaching in pharmacy practice at Ohio’s University of Findlay, winner of the 64GB iPad Mini — she was one of almost 750 people who took our 10-minute Pharmacy Compounder Profile survey.

As that name suggests, we’ll be using those responses to create a nationwide profile of pharmacy compounding, due out in late summer or early autumn. That profile in turn will help APC’s advocacy efforts on your behalf. Thank you to everyone who took the time to respond!

The public is losing trust in health agencies

A recent poll found that only 37% of Americans have a great deal of trust in the FDA. The CDC did better (52%) and HHS did worse (33%) but overall both state and federal agencies are suffering from a lack of public trust. The poll doesn’t ask details, but there is a clear political divide; “27% of Republicans greatly trust CDC, compared to 76% of Democrats.”

Maryland is looking for a pharmacist

Maryland is looking for a pharmacist to serve on the state’s Naturopathic Doctors Formulary Council. A background in pharmocognosy is preferred, and practicing in Maryland is required. Application deadline is noon on Friday, May 21, 2021.

Finance Committee meeting

The Senate Finance Committee will hold a hearing on “Covid-19 Health Care Flexibilities” e.g., telehealth. It’s this coming Wednesday, May 19 at 10:00 am EDT. Click here for info.

Weird statin stat

A study of the records of almost 11,000 patients found that prescribers prescribe fewer statins as the day goes on. And we’re not just talking early morning vs. late afternoon: “[C]ompared with patients who came in at 8:00 am, patients who came in at 9:00 am were 12% less likely to get a prescription. Patients coming in for noon appointments were 37% less likely to get a statin prescription.”

A welcome new wrinkle on FDA’s MOU

FDA has launched a new web page to help answer questions regarding the MOU. Of note is point number 6, which is new information:

Can a state that is prohibited by a state law from disclosing a complainant’s name and contact information fulfil the agreed upon data reporting under the MOU?
Yes. Under the MOU, the state is agreeing to report the name and contact information of the complainant, if available, to FDA. If providing this information is prohibited by state law, FDA does not consider it to be “available” for purposes of the MOU.

That could make a difference for states such as Florida that have indicated concern that the MOU conflicts with their confidentiality laws.

Which states have signed? Will sign? Won’t? Here’s the latest map from NABP (click to enlarge:)


(It’s also available on the NABP website.)

REMINDER: While the MOU is flawed, APC’s position is that compounders need to reach out to their board of pharmacy now and urge the board to determine if it can or will sign. Several states have discovered that state law prohibits them from signing.

If your state determines it can sign, urge it to do so before the October 26 deadline. If it determines it cannot sign — and it’s best to determine that now, and not at the last minute — the board of pharmacy needs to contact FDA immediately and urge the agency to extend the signing deadline. Ultimately, it’s better for states to sign the MOU if they can, than to have a catastrophic five-percent cap imposed on out-of-state shipments of compounded preparations.

APC members briefed on MOU reporting

APC held a virtual briefing Thursday with Melissa Madigan of NABP. She explained how reporting would likely work (including what information would be gathered and how it would be used) in states that sign the MOU and choose to use NABP’s online reporting tool. She also demonstrated that tool — the Information Sharing Network (ISN) — which states can choose to use for their reporting to FDA under the MOU.

The system will collect or calculate compounded-prescription information and notify state boards about inordinate amounts shipped out of state — that is, more than 50 percent of compounded prescriptions in states that have signed the MOU. Boards will then be required to pass that information to FDA. Note that it is perfectly legal to ship that much out of state, but it may trigger a closer look by the BoP or FDA.

Compounding pharmacies will need to submit their prescription information annually. If their state chooses to use NABP’s ISN, it can be done through the pharmacy’s existing NABP e-Profile and will look like this (click to enlarge):

(Currently the ISN is manual — it does not connect with pharmacy software platforms, although Madigan said it would consider building such a connection.)

Anticipating more questions, NABP has built a website full of information about the MOU and how information will be shared — it also answers a lot of questions about the process.

Missed APC’s briefing yesterday? No worries. We’ve made it available for viewing here.

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