Anticoagulation Therapy
The final item of business is a members’ business debate on motion S3M-6654, in the name of Nanette Milne, on increasing access to self-monitoring and self-management of anticoagulation therapy. The debate will be concluded without any question being put.
Motion debated,
That the Parliament notes that the levels of self-monitoring and self-management in Scotland for anticoagulation therapy are considerably lower than in England and the rest of western Europe; notes that the Royal Hospital for Sick Children (Yorkhill) in Glasgow, which looks after all young people on anticoagulation therapy, has achieved considerable success with the training of young people to self-monitor and self-manage their anticoagulation therapy but that there is no support for them when they move to adult clinics; notes that authoritative studies confirm the cost-effectiveness of self-monitoring and self-management; further notes the Cochrane Review meta-analysis confirming the clinical benefits and outcomes of self-monitoring and self-management; challenges the view of some NHS boards and clinicians that anticoagulation monitoring and management require to be undertaken in secondary care; points to what it considers to be the costly and time-consuming practice of bringing patients from outlying areas to hospitals rather than manage them in primary care; reminds the Scottish Government that its policy document, Better Health, Better Care, states that “patients living with long-term medical conditions and their carers should have the information and support that they need to manage their condition on a day-to-day basis, in the knowledge that the NHS is there for them when they need it”, and would welcome encouragement being given to NHS boards to increase access to self-monitoring and self-management of anticoagulation therapy for those patients in north east Scotland and the rest of the country who, with the endorsement of their clinicians, wish to do so.
17:08
I welcome to the gallery several visitors who have a particular interest in the debate, one of whom has self-managed her anticoagulant treatment for a number of years.
It has been estimated that there are currently around 1 million people in the United Kingdom with various medical conditions who receive anticoagulation therapy to thin their blood. It is expected that that figure will rise by 10 to 15 per cent year on year as the population ages and more effort is made to identify cardiac arrhythmias, notably atrial fibrillation. To ensure the efficacy and safety of that therapy, which is usually given orally as warfarin, and to ensure that its effect stays within the defined therapeutic range, regular monitoring is essential. The dosage is adjusted according to the time it takes for a blood sample to clot.
Because serious complications can arise if warfarin is poorly controlled, it is vital for patient welfare that the clotting time is frequently checked. Traditionally, that has been done via hospital-based anticoagulant clinics. There is often quite a long time lag between the blood sample being taken from the patient, after which it is processed in the laboratory, and the result reaching the clinician and the patient’s dosage being adjusted. Even if the general practitioner takes the sample and posts it to the lab, there will be a wait of several days before the dose can be adjusted. The clinics are extremely busy and overcrowded.
Thanks to modern technology, portable devices are now available that allow patients to self-monitor their blood without having to visit a hospital or their general practitioner, or to wait for results—because the result is available in minutes. It allows patients to manage their warfarin dosage themselves. Alternatively, they can contact their physician with the result of the blood test; their physician will then interpret it and adjust the dose accordingly. I saw a portable meter in use this afternoon. It is impressively compact and seems to be extremely easy to use.
It has been found that around a quarter of patients would be willing to self-monitor but, so far, national health service boards generally do not provide support for self-monitoring or self-management. In Scotland, only one health board—NHS Greater Glasgow and Clyde—does it, and only for children.
We lag behind England—where 60 hospitals support self-monitoring—and the rest of Europe. That is a pity, because there is clinical evidence to show that self-management results in a better quality of anticoagulation as well as a better quality of life for patients. It gives them control of their treatment: testing can be done at home and results are immediate. Self-management means that fewer hospital visits are needed. That could be a significant advantage to patients—particularly in rural areas—who currently must take time off work to attend hospital and bear the expense and time cost of travelling there.
A portable meter costs only £300 and is currently either purchased by the patient or provided by a charity, because the cost is not reimbursed. The annual cost of test strips is around £65. If that cost is set against the £60 to £100 cost to the NHS of each clinic visit and the need for the patient to attend hospital anything between four and 12 times per year—or even more—it is easy to see the advantages to the NHS, as well as to the patient, of self-monitoring the treatment.
As I said, there is little support in Scotland for self-monitoring. The NHS Greater Glasgow and Clyde service for children at Yorkhill is very well received—more than 100 young patients are self-testing—but when they move on at age 18, few adult services will be available to them.
NHS Fife has run a pilot study on self-monitoring and continues to support a small number of patients from the pilot, but the service has not been rolled out. NHS Grampian has a few self-monitoring patients. At present, it does not formally support them, although it is looking to develop a system to do so. Following the transfer to NHS Lanarkshire of a patient from Yorkhill, that health board is now setting up a service, having acknowledged the need to support self-monitoring.
There is growing awareness of the possibility of self-monitoring and self-management of anticoagulation therapy in Scotland but, unfortunately, the Government does not collect appropriate data on young people. That is a pity because although Yorkhill has more than 100 young people who are self-testing, the Minister for Public Health and Sport indicated in response to a parliamentary question that very few people on anticoagulant therapy would be eligible for the approach.
The Government’s document “Better Health, Better Care: Action Plan: What it Means for You” states:
“patients living with long-term medical conditions and their carers should have the information and support that they need to manage their condition on a day-to-day basis, in the knowledge that the NHS is there for them when they need it.”
Key aims of “Better Health, Better Care: Action Plan” are to
“Enable and support patients to be partners in their care ... Make health care in Scotland safer ... Modernise the NHS”
and
“Deliver the quickest treatment ever available in Scotland’s NHS”.
Self-testing and self-management of anticoagulation therapy fit well with that strategy. They are of great benefit to the patients who use them but, beyond that, they seem to be very cost effective for the NHS.
In this day and age we look to use scarce resources as effectively and efficiently as possible. Therefore, I urge the Government to look closely at how anticoagulant therapy is managed and to consider investigating the potential of increasing self-management with a view to rolling it out across health boards to suitable patients. That would save the NHS money and improve the quality of care for the large and increasing number of people in Scotland who need long-term anticoagulation therapy. I commend that approach to the Cabinet Secretary for Health and Wellbeing.
17:14
I congratulate Nanette Milne on securing the debate. I, too, have previously written to NHS Grampian about self-monitoring and self-management of anticoagulation therapy on behalf of patients. It is important to debate it.
I am sure that we all wish to encourage the principle of empowering patients with long-term conditions to take control of their own treatment. As Nanette Milne said, it is a key part of “Better Health, Better Care”.
Clear quality-of-life issues are involved when the self-management of conditions might allow patients to enjoy greater freedom in their day-to-day lives. Requiring patients to attend clinics regularly for their treatment also has implications for time and cost. That is a particular concern for people in rural areas, who may face longer journey times and, therefore, may see more of their day-to-day life sacrificed to managing their condition. Even if such visits are relatively infrequent, there is still inevitable inconvenience to the patients involved. Therefore, I believe that, where possible, it is right to consider alternatives.
It seems strange that youngsters are encouraged to self-monitor and self-manage their anticoagulation therapy but that, when they reach adulthood, they are considered unable to do it. Given yesterday’s budget and the severe cuts that have been passed down from Westminster for this year and the coming years, members will require no convincing of the need for treatments to be cost effective. A shrinking pot of resources is available to the Scottish Government, so the cost of change must, of course, be weighed against the benefit to those with long-term conditions. That said, I believe that we must be prepared to change current practice and I hope that the cabinet secretary will be prepared to examine the merits of the proposal in detail.
Developments in health care move ever faster as every year passes. More and more ways of treating patients are being developed. Keeping up with the pace of change can be a challenge, but when treatments are developed that can provide people with long-term conditions greater freedom from their conditions, I believe that it is right to look long and hard at adopting them if they are cost effective. Encouraging greater independence among people with long-term conditions is always desirable when it can be achieved. I believe that greater self-monitoring and self-management of these treatments has the potential to do that, and I hope that encouragement for such practices will receive the consideration it deserves.
17:17
I, too, congratulate Nanette Milne on securing the debate. I also congratulate her on lodging probably the longest members’ business motion in the history of the Parliament—certainly, it must be one of the longest. More important, there appears to be consensus in the chamber on its substance.
I have no doubt about the value of self-management of long-term conditions. People with long-term conditions want information and support so that they can take control and, when appropriate, be responsible for part of their own care. As Nanette Milne has said, a million patients in the UK receive anticoagulation therapy, and it is interesting to note that there are an estimated 10 to 15 per cent more year on year. That, in itself, puts pressure on the system.
We have had described to us the visit to the hospital-based clinic, the taking of the blood sample, the analysis in the lab, the results coming back, the interpretation by the physician and, finally, at the end of that process, the dose being adjusted if necessary. It seems a long and complicated process, particularly considering that the portable devices that are now available to enable people to self-monitor do away with the need to visit hospital and then wait for results. The use of such devices therefore strikes me as eminently sensible.
The clinching argument for me is that using the portable devices makes financial sense, too, considering the cost of each hospital visit—between £60 and £100—and the number of times per year that people need to go to hospital, never mind the loss of salary for those who need to take time off work. The cumulative total is well in excess of £1,000, whereas the cost of a portable meter is just below £300 plus the cost of the strips each year. It makes financial sense.
I realise that self-monitoring is not for everybody and that some patients will not be comfortable doing that, but we should enable those patients who want to do that to do it.
As someone who represents a constituency that is served by NHS Greater Glasgow and Clyde, I am pleased that it supports self-management of anticoagulation therapy at Yorkhill hospital. However, like Nanette Milne, I regret the fact that that stops when the patient turns 18 and becomes an adult. It would have been sensible to roll the initiative out so that adults could access self-management, too. I hope that that is considered.
As the numbers are increasing, the pressure on the system will increase, so self-management makes financial sense for the NHS and, probably more important, for the patient. It means no travelling and no waiting. Empowering and enabling patients to participate in the management of their own care is quite a powerful thing to do, and it is the direction of travel that we should take with all long-term conditions.
I again congratulate Nanette Milne and, in doing so, indicate my support for her motion.
17:20
I thank my colleague Dr Nanette Milne for securing the debate and admit that my knowledge of anticoagulation therapies is considerably greater than it was two hours ago, when I sat down to write my speech.
Like others, I know of people who are on medications that have been found to be effective in preventing thrombosis and embolism but, despite their effectiveness, I understand that they can have several shortcomings. I have learned that many commonly used medications interact with warfarin, as do some foods, and that its activity must be monitored by blood testing using the international normalised ratio to ensure that adequate but safe doses are taken.
As Nanette Milne said, blood samples are sent to labs through the operation of a centralised anticoagulation clinic. There is no doubt that hospital-based services can be inconvenient for patients and expensive to the taxpayer, and Nanette Milne mentioned the time delay. If better care can be achieved through greater emphasis on self-management, we should encourage that.
I understand that stable patients will make visits to the hospital or GP about every 12 weeks but that unstable patients might have to do so every week. The provision of self-monitoring equipment—which is now far cheaper than it was in the 1990s—to patients for use in their own homes has two substantial benefits: the first is in cost and time, and the second relates to control. Regular INR testing is essential in providing patient stability, and home-based units can be used as frequently as necessary.
As Jackie Baillie said, it must be acknowledged that not all patients will adapt to self-management, but many will and they should be given the opportunity to do so. Putting patients in the driving seat on their own health is undoubtedly empowering and might even help them to understand the cause of the changes in their readings. It is about treating patients with dignity, trust and respect, and allowing them to adjust their drug levels depending on the results.
Earlier today, I picked up an NHS Quality Improvement Scotland evidence note on the issue from the back of the chamber. It may be a bit out of date—it is dated May 2009—but I would still like to quote from it. It says:
“Recent systematic reviews and meta analyses indicate that for selected and well trained patients, self-monitoring of oral anticoagulation therapy (OAT) is safe, more effective than usual care provided by family doctors and as effective as monitoring undertaken in specialised anticoagulation clinics and laboratories.”
That is the good news. The bad news, on which I trust that the cabinet secretary will provide clarification, is that
“Two recent economic models concluded that patient self-monitoring and testing of OAT was not cost effective compared to clinic-based usual care.”
I hope that the cost of anticoagulation therapy will be compared with the cost of hospital admissions and clinical care.
It seems incredible that only one health board has made provision for self-testing and self-management in adults, and that Scotland lags behind England and the rest of Europe on levels of self-monitoring and self-management. Given that it is estimated that a million patients in the UK receive such therapy, the figure for Scotland is likely to be around 100,000.
I hope that tonight’s debate will raise awareness and assist in increasing access to self-monitoring and self-management of anticoagulation therapy.
17:24
I, too, congratulate Nanette Milne on securing the debate, which will have the effect of raising awareness of an issue that I know is important to large numbers of patients.
Notwithstanding the comments that I will make about the current situation and the reasons for it, I want to make it clear at the outset that I will examine all the points that were made in the debate tonight. I am particularly keen to examine the position in England, which a couple of members have mentioned, to see whether there are any lessons that we can learn and apply here.
As other members have said, warfarin is an effective medication for patients with conditions that involve an increased risk of clotting. However, it needs careful management. Too high a dose can cause major internal bleeding, and that could be fatal; too low a dose increases people’s risk of a heart attack or stroke.
As the motion makes clear, and as has been said by all the speakers in the debate, the Government supports the self-management of long-term conditions, not only because of its benefits to patients but because of its benefits to the NHS. Self-management is an integral part of our quality strategy and, as Nanette Milne pointed out, it is at the heart of the action plan in our “Better Health, Better Care” document. There should be no doubt about the Government’s commitment to promoting self-management where that is right and proper for patients.
I am sure, however, that members will agree that, when it comes to deciding the correct approach to any individual condition, those decisions should never be political and should always be guided by the best clinical evidence. Given the serious safety issues that are involved in anticoagulation therapy, we need to be wary about the self-management of warfarin. The self-management programme in the Government’s long-term conditions unit has produced a film using warfarin as an example to illustrate the dangers that are caused by misunderstanding and poor communication in medicines management. Warfarin is also the subject of a safety improvement pilot project in primary care, as part of the Scottish patient safety programme. I hope that both those examples give an indication that warfarin is very much on our agenda with regard to the issues that we are discussing.
We can agree that self-management might be a little way down the road, but self-monitoring is a good start, as patients can get the results of their blood-clotting tests at home, instantly, and can then get advice from a consultant.
Nanette Milne is right to point out that self-monitoring involves people checking the results of their tests and then sending them to a clinician who makes the decision about dosage and that self-management involves people calculating their dose themselves. Everyone in the chamber knows that, but it is an important distinction, and I appreciate the point that Nanette Milne makes.
I want to refer to the evidence base that lies behind the fact that boards do not more generally support the self-monitoring or self-management of anticoagulation therapy. In doing so, I am not suggesting that anything is set in stone—such matters must always be kept under review.
The guidance that was produced by the chief medical officer and the chief pharmaceutical officer in 2002 makes it clear that there are a number of conditions that must be met before self-management can be recommended. Patients must be able and willing to perform self-management, their competence to do so must be assessed, they must have given their informed consent in writing and they must have gone through rigorous training.
Self-monitoring is an option for only some patients, as everyone who has spoken has acknowledged. That is borne out by the evidence note that was published by NHS QIS in May 2009, and which Mary Scanlon has already quoted from. It points out that, for every 100 people who are eligible, only about 14 would be able to undertake effective, long-term self-monitoring. To come back to Nanette Milne’s distinction, the number of people who are able to self-manage is likely to be even smaller.
The motion discusses clinical and cost-effectiveness and Mary Scanlon asked some specific questions about that. I am aware of the results of a trial that was reported last month in the New England Journal of Medicine that suggest that people who self-monitor are more often within target range and enjoy a better quality of life. They did not, however, show that they have better clinical outcomes than those having monthly monitoring at clinics. Further, as the NHS QIS evidence note points out, two recent economic models concluded that patient self-monitoring was not cost effective compared to clinic-based care. However, that situation is not static and is likely to change over time.
I stress that such decisions should always be taken on an individual basis and, where it is appropriate for individual patients, they should be appropriately supported.
Before I continue, I welcome those who are in the public gallery this evening.
To pick up on Maureen Watt’s point, the evidence note acknowledges that self-monitoring and self-management can have particular advantages in remote and rural areas, such as the north-east, by reducing the number of journeys in the patient pathway. For that reason, there has been a shift away from hospital clinics towards monitoring as the responsibility of primary care, which is more convenient for patients than hospital attendances.
The motion refers specifically to the Yorkhill service and its success in training young people to self-monitor and self-manage. Those are mainly children with congenital heart disease who may have had a heart valve replacement, so the numbers involved are fairly small.
The motion suggests that there is no support for young people to continue self-monitoring when they move to adult clinics. Young people in NHS Greater Glasgow and Clyde who make the transition are supported by the Glasgow and Clyde anticoagulation service in self-monitoring and self-management.
For those with congenital heart disease who make the transition from Yorkhill to adult services, care is provided by the Scottish adult congenital cardiac service, which is a national service that is based at the Golden Jubilee national hospital. There is no doubt that a clear protocol must always be in place to cover the transition from Yorkhill to the adult service. There must also be a proper referral pathway back to people’s board of residence for anticoagulation therapy follow-up.
In considering the issue, we need to think about the impact of the new drugs that are on the way to replace warfarin. Just this week there were reports of research by Scottish scientists into one of the drugs, rivaroxaban, to treat people with atrial fibrillation. It was shown to be simpler to administer, and those who were taking it had fewer strokes and blood clots than those on warfarin.
The new medications are considerably more expensive, so they will have an impact on drug budgets. However, they do not require blood level monitoring, which would lead to significant changes in the delivery of anticoagulation services. They might reduce the number of hospitalisations, given that warfarin is third on the list of drugs that cause hospital admission through adverse effects. The Scottish Medicines Consortium has set up a short-life working group to help boards to understand the actions that they must take to introduce those new medications safely and effectively.
I stress that we enthusiastically support the self-monitoring and self-management of long-term conditions, when that can be done appropriately and safely. We will always seek, as is the case with warfarin, to consider what else boards should be doing to ensure that individuals for whom it is appropriate are properly supported.
For those for whom it might not be appropriate, we will continue to encourage warfarin monitoring through GP practices, supported by wider primary care teams rather than by hospital attendances. In most cases, the results from the blood samples that are taken by a GP practice are available on the same day. That model is available in NHS Grampian, and it is generally regarded as successful. It provides reassurance that the therapy is being delivered conveniently, safely and effectively for patients.
I thank Nanette Milne for raising an important issue, and I thank those who have joined us in the public gallery, who are living proof that the therapy can be delivered in this way. I give an assurance that we will examine carefully all the points that have been made in the debate.
Meeting closed at 17:33.