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The Parliamentary Under-Secretary of State for Health (Caroline Flint): I congratulate my hon. Friend the Member for Aberdeen, South (Miss Begg) on securing this debate. This is an important issue, and her questions on health and health care issues are always thoughtful and thought-provoking. I acknowledge that the relationship between a GP and a patient in relation to pain management is a very personal one. Each individual needs to describe how pain is affecting them personally, and the response can change from one person to another. As my hon. Friend has rightly said, this is also a very complex issue.
My hon. Friend has brought to our attention the concerns of her constituent, Jonathan Russell, about the withdrawal of co-proxamol. The Department has received about 130 letters from Members of Parliament writing on behalf of their constituents about this issue. My hon. Friend also mentioned Arthritis Care, and I would like to acknowledge the good work that that organisation does to support those who suffer from arthritis. It provides an experienced and knowledgeable voice on the issue of patients' rights, and also works with health professionals. The decision to withdraw co-proxamol was not an easy one to make and followed an extensive risk-benefit assessment, a wide public consultation and advice from the Committee on Safety of Medicines. The Government's independent scientific advisory committee on medicine safety also contributed, as did other experts.
Co-proxamol is a combination of a weak opiate painkiller with a relatively low dose of paracetamol and has been available since 1965, before the current system of medicines regulation existed. As a long-established medicine, it has not been subjected to modern standards of clinical researchclinical trials then were often either poorly designed or of very short duration and on the whole did not produce definitive results. As such there is a lack of evidence that co-proxamol is more effective than full-dose paracetamol. Despite the lack of evidence, many prescribers considered it to be a useful alternative to non-steroidal anti-inflammatory drugs such as ibuprofen and more potent opiates in situations in which paracetamol alone is ineffective.
On the other hand, the dangers of a co-proxamol overdose, especially when taken with alcohol, are well established and, I am afraid, cannot be ignored. Co-proxamol is involved in 300 to 400 self-poisoning deaths each year, of which around a fifth are accidental. Many deaths involve people taking co-proxamol that has not been prescribed to them. Co-proxamol can be very toxic, and overdose can occur with only a few tablets more than the recommended daily dose. Toxicity from co-proxamol overdose is extremely rapid compared with that from other pain-relieving medicines, so, sadly, victims often die before they reach hospital. Unlike paracetamol, there is no effective antidote to co-proxamol poisoning. Importantly, paracetamol is considered to have a comparatively good safety profilethe onset of toxic effects is slow, allowing more time for effective treatment.
Advice from the CSM aimed at the reduction of co-proxamol toxicity and fatal overdose dates back as early as 1985. You can therefore see, Mr. Deputy Speaker, that the issue has been discussed for a considerable time. Sadly, this advice has not been effective in preventing the deaths that occur each year
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following a co-proxamol overdose. The growing concern was prompted by recently published UK research using data from the Office for National Statistics showing that co-proxamol alone now accounts for almost one fifth of drug-related suicides and is second only to tricyclic antidepressants as an agent of fatal drug overdose. Concerns have also been raised by Sweden in the European Parliament.
In light of the lack of evidence that co-proxamol is any more effective than full- dose paracetamol in pain management, and its high toxicity in overdose, the expert advice of the Committee on Safety of Medicines was sought. During 2004, the CSM comprehensively reviewed all the available evidence regarding the risks and benefits of co-proxamol. A public call for evidence on the risks and benefits of co-proxamol was also conducted for 12 weeks in 2004. The Medicines and Healthcare products Regulatory Agency wrote directly to a large number of organisations representing healthcare professionals, patient groups and other stakeholders as well as publishing the request for information on the MHRA website. Comments from patients and members of the public, as well as health care professionals, were welcomed. The CSM reviewed all the responses to this call for evidence and also international evidence on the safety of co-proxamol. During this review, the CSM noted that previously strengthened warnings to doctors and patients on the hazards of co-proxamol have unfortunately proved ineffective.
After considering the wide range of available evidence and the options for action to reduce the risk of overdosefor example, prescriber and patient education, smaller packet sizes and restricted indications, as my hon. Friend outlinedthe CSM determined that the risks of co-proxamol outweighed the benefits of allowing the medicine to remain on the market. Following advice from the CSM, the MHRA has therefore agreed with the manufacturers to withdraw co-proxamol over an extended period of time in order to allow long-term users an opportunity to adopt suitable alternative pain management strategies. The CSM advised that the withdrawal of co-proxamol should be phased over a period of up to 36 months, or to an earlier timetable to be agreed with manufacturers. Most manufacturers have indicated that they intend to withdraw the drug over a period of approximately six to 12 months. A few have indicated that they wish to phase the withdrawal until the end of 2007.
Over that period, we expect to see the prescribing of co-proxamol decline as patients are moved to suitable alternatives. To help doctors find the best options for individual patients, the MHRA has issued CSM pain management guidance. Available data on sales at wholesale level suggest that the sale of co-proxamol is slowing down steadily. There has been as much as a 10 per cent. month-on-month decline since June 2004, and total supply has more than halved in the six months since the announcement was made. An article in the May edition of Pulse was authored by a GP who has reduced the number of patients in his care on co-proxamol from 438 to 20. That demonstrates that good GP care and discussing the various issues with patients can effect a change to an alternative that works.
Caroline Flint: Sensitive discussion that takes into account all the options can effect a smooth transition to an alternative. However, the GP in question does acknowledge that, for a minority of his patients, other alternatives have not proved an option. However, a reduction from 438 to 20 is a significant one.
Miss Begg: To judge by what my hon. Friend said earlier, it appears that stocks will run out, so even for the minority who found co-proxamol the most effective remedythey include my constituentthere will be an end date by which the drug will be completely off the market. Is that correct?
Caroline Flint: I will address that point shortly, as I want to clarify the situation for the minority of patients who have agreed with, in most cases, their GP that there is a clinical need to continue with the prescribing of co-proxamol.
Many local formularies, including in Northern Ireland, have already phased out co-proxamol altogether. It has been on the market for 40 years and it is clear that some patients have been established on this medicine for a long time, so I realise that the action that has been taken must be very distressing. The Department has received many letters from patients who are upset at its withdrawal. I have sympathy for them, but I am encouraged by the progress that has already been made in shifting to other forms of pain management. The decision to withdraw co-proxamol from the market has tested medicines regulation to the extreme. However, weighed against the difficulties caused to individual users is the clear public health gain in removing a medicine that has been widely implicated in accidental and non-accidental overdose.
At the end of the phased withdrawal, and following the cancellation or withdrawal of licences for existing products, provision will remain for the supply of unlicensed preparations. I understand that the drug will continue to be available on a named patient basis, and that the MHRA will communicate that fact clearly. Its doing so should deal with the question of supply, but I will check this point for my hon. Friend and I am happy to write to her about it.
Individual patient use of co-proxamol preparations could continue, with responsibility for such use falling primarily on the prescriber, who is usually the GP. In this way, where a clinical need exists and alternatives have proved unsuccessful, it will still be possible to prescribe co-proxamol, but in a more targeted way than in the past, and with a stronger focus on the risk-benefit judgment for the particular patient. I hope that that judgment will be reached through a strong relationship between patient and prescriber that establishes the patient's needs and their need to use this drug.
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