Follow The Clozapine REMS Program Path?

The Path“All paths are the same: they lead nowhere. … Does this path have a heart? If it does, the path is good; if it doesn’t, it is of no use. Both paths lead nowhere; but one has a heart, the other doesn’t. One makes for a joyful journey; as long as you follow it, you are one with it. The other will make you curse your life. One makes you strong; the other weakens you.”
― Carlos Castaneda, The Teachings of Don Juan: A Yaqui Way of Knowledge

So, just before Halloween, I thought I’d outline the path of my journey through the Clozapine REMS Program by listing the messages from them and my steps along the way:

After faxing my Knowledge Assessment for Healthcare Providers and Prescriber Enrollment Form at 8 AM on 10/12/15, I got an email address verification alert on that same date, followed by a web account complete notification message the same day. So I have a web account and subsequently received the message that I “may now certify into the program at the website or fax enrollment form to 1-844-404-8876.” I refaxed these forms on 10/30/15 (because the website is dysfunctional and I’ve never been able to certify) and got a transaction report indicating that it went through.

The message I repeatedly received from the website for several days well past 10/16/15 was, “It appears your certification is already in progress based on the information provided. Please resume your certification from the dashboard.” This led nowhere; it was a circular path that quickly bored me.

Then I started over by getting a new username and password, so that by my entering my original username and password,  I started getting the message, “It appears a certification may have already been started based on the information provided under a different user account. Please sign in with that account to complete your certification process. If you need assistance please contact the Clozapine REMS Program at 844-267-8678.”

I tried the new username and password several times and kept getting the message, “Your web account for the Clozapine REMS Program has not been activated.” Indeed, it has never been activated because I never got the email address verification or the web account complete notification messages for the new user login data.

When I was trying the new user login data, I would also get the message, “To activate your web account, please use the verification link within the email we sent you during the sign up process. If you do not see the email, please check your junk mail folder as it may have been filtered; otherwise, please contact the Clozapine REMS Program at 844-267-8678 for assistance.” My junk mail folder was empty. I have not received further messages from them–but if I did, I would probably consider them junk.

When I try to start over again (a third time), I get the message, “A user account with the information you provided already exists. Please sign in to your account. If you need assistance please contact the Clozapine REMS Program at 844-267-8678.” So I can’t just start over.

Dr. Amos on phone 2Calling the Clozapine REMS Program at 844-267-8678 for assistance has either resulted in long hold times, which were eventually replaced by messages to leave my “10 digit phone number starting with the area code,” usually resulting in delays in return calls from them or calls when I was out of the office, once close to 7:00 in the evening. When my calls are returned, they’ve gotten my name wrong (“Dr. Davis”), given me fictitious dialing options (the infamous and nonexistent “Option 8”), or they only want “information”, which I’m putting here so that I can read it to them if they ever call me again. They never call to actually help me certify.

The one useful message I’ve received has been the reminder that, because of the glitches in this fiendish system, I should not forego dispensing Clozapine to the patients who so desperately need it, those with treatment-resistant schizophrenia. I have given the clozapine because it’s the right thing to do. That I am not certified is neither here nor there since, ironically, this program which was designed to simplify the difficult monitoring process, has only made it impossible for some of us.

I have emailed the FDA twice, “Should you have questions or concerns about the Clozapine REMS Program, please contact the FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400; Monday – Friday, 8am – 4:30pm EDT.” They say they’re sorry I’m having problems and indicate they’ve asked the Clozapine REMS Program Managers to contact me directly. This has not happened, at least to my knowledge.

That has been my path. I have followed it since 10/12/15 and I would say this path does not have a heart. It certainly has led nowhere thus far. I don’t curse my life because of the path…I curse the Clozapine REMS Program and the FDA which approved it. However, it is also clear that my experience is not shared by everyone. Some people have gotten through without a hitch–I’ve spoken with them. And the Clozapine REMS Program poll reflects that a few stakeholders find the system satisfying. I did say “a few.” But I continue to follow this path, maybe just to see where the heck it goes.

Dr. Jim Amos Scary TieMaybe this is a Halloween trick–a very long and tedious trick, like a path full of brambles and poison ivy. Have a Happy Halloween!a path in

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Comments

  1. https://jajsamos.files.wordpress.com/2015/10/dr-amos-on-phone-3.jpgPhone time with the Clozapine REMS reps OK, I’ve talked to 3 Clozapine REMS Program representatives this morning, one of whom told me that a “manager” probably would not be helpful. I saw that one coming.

    I’m still not certified and it’s half past noon.

    My contribution to this mess? I forgot to sign my name and date on the enrollment form I faxed. But that’s small potatoes. If the website were functional, I could have done that long ago electronically.

    The one rep told me that he was emailing me the email address verification alert for my new username even as we spoke. We both waited–nothing. How long does an email take to travel through the ether? No email yet. No web account complete notification.

    No bananas. I know what it is. I didn’t do the Day-O Dance.

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  2. Just for fun tried signing in today, Sunday Nov. 1, 2015. I tried the original user login and I got the alert, “The account information provided could not be found. Please try again.” Of course, all subsequent attempts trigger the same alert.

    So I tried starting over. This triggered the message “A user account with the information you provided already exists. Please sign in to your account. If you need assistance please contact the Clozapine REMS Program at 844-267-8678.”

    But I just did that…

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  3. Shortly after 5 PM, a Clozapine REMS Program representative called me just as I was heading out the door. He apologized and said they’ll have a “fix” soon for my problem with this mess (and he agreed that it was a mess). We had a chuckle when I compared it with Healthcare.Gov.

    Wait and see.

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