SilentCallsVictim wrote on Aug 4
th, 2009 at 11:41am:
I have enquired of the Department of Health and will post any useful information that comes back.
I now have some information, helpfully picked out for me by a helpful agent on the DH helpline.
I quote below from what I am assured is the only relevant document covering these proposals that is published at this time. More detailed proposals may well be published in due course. The following quote is from 7.6 (ii) on page 20 of
The Pharmaceutical Price Regulation Scheme 2009. (This covers a period of five years.)
Quote:Subject to discussion with affected parties, the Department will introduce generic substitution in primary care. This will enable pharmacists and other dispensers to fulfil a prescription for a branded medicine by dispensing an equivalent generic medicine. Provision will be made to allow the prescriber to opt out of substitution where, in their clinical judgement, it is appropriate for the patient to receive a specific branded medicine. In these circumstances, the named brand must be dispensed. Provision may also be made to exclude certain categories of medicines for clinical reasons in the interests of patient safety.
The earliest date for the implementation of generic substitution it set to be January 2010.
The petition is simply a means of canvassing support for the exclusion of particular categories. Provision is already made for this, and it would seem unlikely that the view of NICE would not be considered in determining which categories are to be treated in this way. It is far too soon to allege that the particular drugs in question are not to be subject to this exemption. There is however no reason why well-organised interest groups could not canvass support for their particular case.
One hopes that the exemptions will be properly drawn so that the benefits of generic substitution may be gained where this is appropriate. The leading members of the pharmaceutical industry will doubtless be campaigning for as many exemptions as possible.
Most important perhaps is the provision for the prescriber to opt out of substitution. This is where the responsibility should lie. If the prescriber is perhaps unaware that a suitable generic substitute is available then it is fair for them to prescribe by name, but leave it open to the dispensing pharmacist to make a substitution if one is available. If they are unwilling for a substitution to be made then they must carry the responsibility to indicate this.
For the scheme to work, it is vital for prescribers to be aware of when substitution is not appropriate, so that whole categories of drugs do not have to be covered by exemptions simply to prevent inappropriate substitution in a few necessary cases.
I hope that the needs of sufferers from epilepsy and their carers will be properly met, and do not believe that they have yet been overlooked. The petition will help to ensure that this does not happen. I also hope that the same care will be taken in respect of sufferers from all other conditions, especially those without powerful lobby groups to argue their case.
As always, all manner of problems will emerge with the implementation, but I will leave speculation about this to those who are better aware of the relevant procedures.
Barbara is to be thanked for generously stating that epilepsy is but one of perhaps many conditions where there is a case for exemption.
It could be seen as odd that neither the petition, nor the information on the JEC website, makes any reference to the highly relevant provisions in the proposal. This would have perhaps enabled an explanation as to how they may be unsatisfactory in nature and why the drugs in question are unlikely to be covered by an exemption to be provided. If the petition had said “
there are to be exemptions, please ensure that the following groups of drugs are on that list and that this provision is not dropped” it would have attracted far fewer signatures and generated far less possibly unnecessary concern.
(If there is any serious reason to believe that these fairly obvious and sensible provisions are likely not to be part of the scheme when it is implemented, then I would be happy to withdraw these remarks. At the time of writing I am not aware of any.)