By David G. Miller, RPh, IACP Executive Vice President & CEO
Weekend before last, Sarah (IACP Vice President of Government Affairs) and I had the opportunity to give a presentation at the annual convention of the American Veterinary Medical Association (AVMA). Our original topic was to give an overview of the US v. Franck’s Lab, Inc. case.
But that case is complicated if you haven’t been involved with it every step of the way, you might be surprised at how broad it really is.
It involves the Food and Drug Administration’s (FDA) failure to publish its Veterinary Compounding Compliance Policy Guideline (CPG) for public comment and input from practitioners and the public. It involves years of back-and-forth between Congress and the FDA about the CPG. It deals with the basics of federal and state jurisdictional authority over compounding. It even raises the question as to whether a medication compounded for a specific patient for a specific medical condition in an individualized strength or dosage form is a “new drug” and therefore, according to the FDA, should go through the mandatory review and approval process.
Now, I’ve been making the rounds of pharmacy association meetings, IACP regional conferences, and talking about this for the past six months. Bear in mind, the conversations I’ve had and the presentations I’ve given were to pharmacists. It’s like talking to “family” because we all have the same basic education, the same kinds of good and bad experiences in pharmacies…a kinship. We laugh together. We gulp and say “uh-oh” when we realize something we thought we knew about the law turns out not to be accurate. We even fight amongst ourselves to take home a little stuffed elephant named Alfonse.
Talking to the vets was different. As a speaker, I’m used to the kind of engagement I get from “the family.” The AVMA attendees sat there totally stone-faced. No smiles. No chuckles. No looks of interest. And I think to myself while continuing to babble on… “What’s going on here? What’s not working? What am I doing wrong?”
About 20 minutes into the lecture, a vet raises her hand. I’m expecting a question. Instead, what I got was:
“This is all very interesting but this whole CPG thing you’re talking about… that’s for pharmacists. We’re vets. This doesn’t really apply to us.”
For a good 10 seconds there was dead silence. And for a speaker, 10 seconds of silence seems like forever.
I managed to pick my jaw up from the floor (and Sarah did the same thing except she was sitting at the dais’ table running my slides for me), gulped, and with great and incredible eloquence, with words worthy of a great orator of old, gave my response:
“Uh…um…yeah…it does…the CPG applies to everybody… uh…I mean…um… anybody that compounds for veterinary use.”
And it was kind of mollifying to see their jaws drop.
Things got a lot more active after that. A quick audience poll showed that less than ten of the 100 or so people in the room were familiar with the Veterinary Compounding CPG, knew that it was relevant to veterinarians and that they were responsible for complying with it just as well as pharmacists. And everyone in the room compounds. Turns out that many vets are not only not familiar with the CPG, they were just as appalled that it’s written in a manner that prohibits the use of Active Pharmaceutical Ingredients (API’s) for compounding for non-food animals.
The presentation ended with lots of questions and visits to the IACP booth in the exhibit hall afterwards.
But that’s not quite the end of the story. Aside from kicking myself – my fault for not doing a basic “what do you know?” poll at the beginning – I realized that this genuine lack of knowledge is an incredible opportunity for IACP members. It means that there is a great need to sit and talk with vets about the commonalities we share with them – not just patient care but also legal and regulatory challenges. It means that a compounding pharmacist can deliver value over and above our unique skills in creating formulas for animal medication therapy.
So, call. Make an appointment. Visit with the vets in your area. Talk to them about the CPG and what it means to them. Tell them what you and your Academy are doing to preserve prescribing and compounding decision making where it belongs – in the hands of educated health professionals. Tell them that you are their ally in protecting their profession just as they can be for us.
But, take my advice. Don’t assume they know what you’re talking about before you start. It will probably be a big revelation to them just as it was to the audience at AVMA. And be prepared to hear a jaw hit a desk.
Because yes, indeed, the CPG applies to all compounders; physicians, veterinarians, and pharmacists.