cat_100
08-09-2008, 12:39 AM
Ex,
You mentioned a COVERS risk management program for fentanyl and maybe oxycodone in one of your posts. Sounds interesting. Do you have any more information about it?
Cat
You mentioned a COVERS risk management program for fentanyl and maybe oxycodone in one of your posts. Sounds interesting. Do you have any more information about it?
Cat
Sponsor
Executor
08-09-2008, 02:22 AM
Yes, I do. I found this information after I read the Q2 conference call where Cephelon executives mentioned it in their brief to analysts. Analysts wanted to know if Cephalon thought the FDA would make COVERS mandatory across a wide range of high powered CIIs, and the execs answered "yes"....Especially fentanyl related products.
I then found the information in the transcript of the meeting where Cephalon presented it's comprehensive case to the FDA. One can find these FDA transcripts and applications very easily.
Essentially, COVERS is centered around a Doc and patient registration system. The patient goes to the pharmacy to get a prescription filled but only when the access verification system confirms that both patient and prescriber have registered can the transaction be completed. If the access verification system does not confirm registration, there is a hard stop.
They outlined the following example:
Prescribers call a 1-800 number, listen, and attest to their understanding of the safety messages and register using a unique registration number. The prescriber issues a prescription to the patient together with the safety activation card. The patients call that 1-800 number,listen, and attest to their understanding of the safety messages and enter the unique number of their safety activation card. The patient can now visit the pharmacist to have the prescription filled.
The other example they gave was:
The pharmacist initiates the reimbursement through the computer terminal. The access verification system checks in the registration database to confirm that both the patient and the prescriber have registered. And if both have, the pharmacist receives a pop-up message prompting for confirmation that the patient is opioid-tolerant.
They didn't explain how the "registration" process worked in the second example.
As I explained in my prior post, Cephalon has petitioned the FDA for a very wide label on Fentora. The FDA is worried about both diversion and safety of the product, as well as other strong CIIs.
Sounds like a awful lot of oversight to me. Additionally, if required, I'm wondering if there will be a "grandfather" type clause?
Hope this helps answer your question.
Regards,
Ex
I then found the information in the transcript of the meeting where Cephalon presented it's comprehensive case to the FDA. One can find these FDA transcripts and applications very easily.
Essentially, COVERS is centered around a Doc and patient registration system. The patient goes to the pharmacy to get a prescription filled but only when the access verification system confirms that both patient and prescriber have registered can the transaction be completed. If the access verification system does not confirm registration, there is a hard stop.
They outlined the following example:
Prescribers call a 1-800 number, listen, and attest to their understanding of the safety messages and register using a unique registration number. The prescriber issues a prescription to the patient together with the safety activation card. The patients call that 1-800 number,listen, and attest to their understanding of the safety messages and enter the unique number of their safety activation card. The patient can now visit the pharmacist to have the prescription filled.
The other example they gave was:
The pharmacist initiates the reimbursement through the computer terminal. The access verification system checks in the registration database to confirm that both the patient and the prescriber have registered. And if both have, the pharmacist receives a pop-up message prompting for confirmation that the patient is opioid-tolerant.
They didn't explain how the "registration" process worked in the second example.
As I explained in my prior post, Cephalon has petitioned the FDA for a very wide label on Fentora. The FDA is worried about both diversion and safety of the product, as well as other strong CIIs.
Sounds like a awful lot of oversight to me. Additionally, if required, I'm wondering if there will be a "grandfather" type clause?
Hope this helps answer your question.
Regards,
Ex
cat_100
08-10-2008, 06:16 PM
Thanks a bunch. Yes, that did answer my question.
For very strong and easily abused medications, that process does make sense to me IF it is used only for the new prescription and not on every refill. Using it on refills seems like it would be not only redundant but a big pain in the tu-tu.
The benefit to us as CP patients is that cutting down on abuse potential will make it easier for us to receive the medications that we need without doctors being afraid of the liability of prescribing them.
I don't think we'll have to worry about doctors not wanting to take the time to call the 1-800 number because they will just have their office staff do it. Hopefully the staff will get it done before we arrive at the pharmacy to pick up our prescription.
Cat
For very strong and easily abused medications, that process does make sense to me IF it is used only for the new prescription and not on every refill. Using it on refills seems like it would be not only redundant but a big pain in the tu-tu.
The benefit to us as CP patients is that cutting down on abuse potential will make it easier for us to receive the medications that we need without doctors being afraid of the liability of prescribing them.
I don't think we'll have to worry about doctors not wanting to take the time to call the 1-800 number because they will just have their office staff do it. Hopefully the staff will get it done before we arrive at the pharmacy to pick up our prescription.
Cat
Executor
08-10-2008, 10:02 PM
Yes, it does have the potential to be a pain, no pun intended. Diversion is a legitimate issue, but there has to be a better way to track the Rxs. I gotta believe most of the "big gun" meds are prescribed by a handful of Docs in a particular area and can be tracked down other ways. I just hope that all the regulation doesn't keep piling up to where good Docs throw their hands up and avoid PM.
Take care.
Regards,
Ex
Take care.
Regards,
Ex