What Would You Do?

By:  IACP EVP/CEO David Miller, RPh

A LOT of stuff crosses my desk about compounding.  Sometimes it’s scientific articles, sometimes it’s mentions in the laypress, sometimes it’s materials that members send me asking for advice or opinions.  Much of that is shared with our Board of Directors as an “FYI… here’s what’s going on.”

Week before last, I received a five-page FAX from a member.  It was a letter from a “Director of Sales” at a compounding pharmacy, with three pages touting the therapeutic benefits of specific compounds, and a “Physician’s Pricing” sheet.  Our member received it from one of his local doctors and wanted to know what I thought about it.

First impression…  “Oh, s&$t”

Second impression…  “Why?  Why did you do this?  You should know better than…”

Third impression… This makes all of us look bad.”

Last Wednesday, I met with Senator Grassley’s staff to talk about our efforts to have the DEA recognize constructive transfer as an appropriate and legal activities for health care professionals.  Constructive transfer is basically this:  I prepare a controlled substance prescription for a specific patient, deliver it to the patient’s physician or prescriber, and the physician administers it to the patient in their practice.  The DEA says that’s illegal and that pharmacies should use either a Form 222 or an “invoice” to transfer a CDS between registrants. 

During the conversation, though, the staff asked about compounders that are essentially manufacturers — modifying a commercially available product and marketing that to prescribers for the sole intent of economic benefit to the pharmacy.  IACP has a simple clear response to that kind of question:   that’s not compounding – compounding is a collaboration between a prescriber and a pharmacist to meet a patient’s medical needs for which commercially available products aren’t appropriate.

Still, that impression was there and it’s often an obstacle to advancing our issues.

Back to the FAX.

Among the multiple “oh no you didn’t” items was this one:

Sildenafil Citrate 110mg (Generic Viagra)        10 caps       $##.## 

How many problems do you see in that one line? 

I counted four and a possible fifth. 

1)      Sildenafil doesn’t have a USP monograph.  What are you “ABC Compounding” Pharmacy using to assure that the final product is correct?

2)      There is no “generic” for Viagra.  It isn’t off patent, no ANDA has been filed with the FDA, it’s a patent-protected brand name drug.  You can’t just make up a “generic” of anything.

3)      You cannot use something that doesn’t belong to you without giving credit.  “Viagra” is a trademark of Pfizer and you didn’t state that on your order form.

4)      There is nothing whatsoever in the clinical and medical literature that justifies a 10% increase in dosing for an erectile dysfunction drug.  More importantly, there were no accompanying warnings about side effects or problems that might be encountered by a patient when using a product dosed higher than what’s approved for use.

5)      As a compounder, I work with prescribers on prescriptions.  If I’m essentially giving them everything (e.g., a pre-printed order form that looks just like a drug company catalog), am I collaborating or just taking orders?

So, here’s the question.  What should IACP do with this (or other similar situations… sadly, this one isn’t the first)?  Should we send it to the Board of Pharmacy?  the FDA?  Pfizer?  Ignore it?  Pretend it isn’t happening? 

It IS happening and it DOES affect decision makers’ opinions about compounders as a group.  The old “one bad apple” phenomenon. 

What would YOU do if you were in my place?