Win2Win
26th December 2006, 16:03
COPROX UPDATE
March 2006 MRHA COPROX licence is not withdrawn until 2007.
Withdrawal of co-proxamol
The conclusion of the risk:benefit review was that co-proxamol should be withdrawn from the market on the grounds that the risks outweighed the benefits. It was decided to withdraw co-proxamol over an extended period of time in order to allow long term users an opportunity to move to suitable alternatives. Co-proxamol was removed from prescribing formularies in some
parts of the UK (e.g. Northern Ireland) several years ago. The withdrawal will be phased over a period of up to 36 months. Some manufacturers have already withdrawn co-proxamol and a few will phase the withdrawal until the end of 2007. To ensure patients are transferred in a managed way we suggest that patients are moved as soon as possible from co-proxamol to suitable alternatives. Data suggests that the number of prescriptions for coproxamol is steadily dropping. However we recognise that there is a small
group of patients who are likely to find it very difficult to change or where there is an identified clinical need; when alternatives appear not to be effective or suitable. For these patients, continued provision of co-proxamol through normal prescribing may continue until the cancellation of the licences at the end of 2007. After this time a provision will remain for the supply of unlicensed co-proxamol, on the responsibility of the prescriber.
Interpretation:
Initial question: Regarding Co-Proxamol withdrawal, has there been a set 'cut off date' given after which Co-Proxamol will no longer be generally available. CSM/MHRA in original bulletin said after 6-12 months but I have never seen this confirmed & since then have seen that will be available on unlicensed/named patient basis. Answer:
We searched on the MHRA website and found a Q&A document that discusses withdrawal [1], which answer two related questions:
"5 When will co-proxamol be withdrawn from the market?
Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative. The Committee on Safety of Medicines (CSM) advised that the withdrawal of co-proxamol should be phased over a period up to 36 months or to an earlier timetable to be agreed with Marketing Authorisation (MA) holders. Most MA holders have indicated they intend to withdraw co-proxamol over a period of approximately 6-12 months. A few MA holders, have however, indicated that their current plans are to phase the withdrawal until the end of 2007 to meet remaining demand depending on their stock situation. Over the phased withdrawal period we expect the prescribing of co-proxamol to decline as patients are transferred to suitable alternatives. As more data are gathered over the coming months on the uptake and continued patient need for co-proxamol, we will be better placed to predict the final date for withdrawal.
6 What about patients who have not managed to find suitable alternatives?
There are a number of alternatives to co-proxamol and the MHRA has issued CSM pain management guidance to help doctors find suitable alternatives for individual patients. There may, however, be a minority of patients at the end of the phased withdrawal period who are unable to use alternatives. For this group of patietns, the provision would remain for the supply of unlicensed preparations. Individual patient use of preparations of co-proxamol could continue with the responsibility for that use falling primarily on the prescriber."
I know a few on here have been taking Co-Proxamol (some may have had it stopped by now), but it appears you can still get it until the end of 2007 now (My GP has stocks till March, and I'll ask him to get more)....but it would appear after that we can still get it unlicensed. Not sure what that exactly means, still off the GP, we pay for it...??...but I see my specialist on the 8th so something to chat about.
I did price them up in the US, 100 for £75 :ooo + P&P + Customs :geek
March 2006 MRHA COPROX licence is not withdrawn until 2007.
Withdrawal of co-proxamol
The conclusion of the risk:benefit review was that co-proxamol should be withdrawn from the market on the grounds that the risks outweighed the benefits. It was decided to withdraw co-proxamol over an extended period of time in order to allow long term users an opportunity to move to suitable alternatives. Co-proxamol was removed from prescribing formularies in some
parts of the UK (e.g. Northern Ireland) several years ago. The withdrawal will be phased over a period of up to 36 months. Some manufacturers have already withdrawn co-proxamol and a few will phase the withdrawal until the end of 2007. To ensure patients are transferred in a managed way we suggest that patients are moved as soon as possible from co-proxamol to suitable alternatives. Data suggests that the number of prescriptions for coproxamol is steadily dropping. However we recognise that there is a small
group of patients who are likely to find it very difficult to change or where there is an identified clinical need; when alternatives appear not to be effective or suitable. For these patients, continued provision of co-proxamol through normal prescribing may continue until the cancellation of the licences at the end of 2007. After this time a provision will remain for the supply of unlicensed co-proxamol, on the responsibility of the prescriber.
Interpretation:
Initial question: Regarding Co-Proxamol withdrawal, has there been a set 'cut off date' given after which Co-Proxamol will no longer be generally available. CSM/MHRA in original bulletin said after 6-12 months but I have never seen this confirmed & since then have seen that will be available on unlicensed/named patient basis. Answer:
We searched on the MHRA website and found a Q&A document that discusses withdrawal [1], which answer two related questions:
"5 When will co-proxamol be withdrawn from the market?
Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative. The Committee on Safety of Medicines (CSM) advised that the withdrawal of co-proxamol should be phased over a period up to 36 months or to an earlier timetable to be agreed with Marketing Authorisation (MA) holders. Most MA holders have indicated they intend to withdraw co-proxamol over a period of approximately 6-12 months. A few MA holders, have however, indicated that their current plans are to phase the withdrawal until the end of 2007 to meet remaining demand depending on their stock situation. Over the phased withdrawal period we expect the prescribing of co-proxamol to decline as patients are transferred to suitable alternatives. As more data are gathered over the coming months on the uptake and continued patient need for co-proxamol, we will be better placed to predict the final date for withdrawal.
6 What about patients who have not managed to find suitable alternatives?
There are a number of alternatives to co-proxamol and the MHRA has issued CSM pain management guidance to help doctors find suitable alternatives for individual patients. There may, however, be a minority of patients at the end of the phased withdrawal period who are unable to use alternatives. For this group of patietns, the provision would remain for the supply of unlicensed preparations. Individual patient use of preparations of co-proxamol could continue with the responsibility for that use falling primarily on the prescriber."
I know a few on here have been taking Co-Proxamol (some may have had it stopped by now), but it appears you can still get it until the end of 2007 now (My GP has stocks till March, and I'll ask him to get more)....but it would appear after that we can still get it unlicensed. Not sure what that exactly means, still off the GP, we pay for it...??...but I see my specialist on the 8th so something to chat about.
I did price them up in the US, 100 for £75 :ooo + P&P + Customs :geek