There was a lot of fuss about this REMS, because Addyi is known to cause hypotension and syncope particularly alcohol is consumed. So the FDA created a REMS that involved special training and official certification for prescribers of Addyi (as well as pharmacies dispensing Addyi).
I mentioned in a previous post that I didn't want to do the training. I assumed it would be something along the lines of the 8 hour training required to prescribe Buprenorphine, and I didn't want to put that kind of effort into it. More importantly, I don't think the drug works, and I thought it would be easier to tell a patient I'm not certified to prescribe Addyi, than to have a long discussion about why it's not a good idea for her to take Addyi. Yeah, okay, that's a copout. I also didn't want to support this Shanda* of the FDA and Sprout (the company that makes Addyi).
*Shanda is Yiddish for something shameful or scandalous. I think Yiddish has much better words than English for expressing exasperation and outrage. Also sounds. An appropriate one here would be, Feh.
Buuuut...I got curious after I got the email. So I checked it out. What's involved is:
1. Read the Addyi Prescribing Information
2. Complete the Addyi REMS Program Prescriber and Pharmacy Training
3. Complete the Addyi REMS Program Knowledge Assessment
4. Enroll by completing the Addyi REMS Program Prescriber Enrollment Form
I want to go out of sequence for this next bit. I'll start with the Knowledge Assessment. Here it is:
Please note, this is not a section of the Knowledge Assessment. This is it. The whole shebang. I didn't need special training to answer this one.
And the training? It took me less time than reading through this post. The main point of it seems to be the Patient-Provider Agreement Form. This needs to be signed by both prescriber and patient, and states that the prescriber has counseled the patient, and the patient understands the counseling.
It's kind of brilliant. The FDA is covered for approving Addyi by the existence of this special "training". Sprout is covered for producing and selling a dangerous drug that doesn't work by putting the burden of counseling the patient on the prescriber. And by covered, I mean legally.
This is what's required of the prescriber:
There might have been something useful in the "training" if it included recommendations for assessing a patient's ability to abstain from alcohol, or suggestions about how to encourage a patient not to drink while taking Addyi. But that would place some liability on Sprout or the FDA. So they didn't do it.
I am definitely not gong to enroll as a prescriber.