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Lord Winston: My Lords, before the noble Earl sits down, will he clarify one point. He referred twice to £60 million of drugs being thrown away. Is that the basic NHS cost of prescribed drugs or is it based on retail prices, as there is a considerable mark-up in chemists' prices?

Earl Howe: My Lords, as I understand it, the figure was estimated by the National Audit Office and relates to the cost to the NHS of the drugs that are thrown away.

8.16 p.m.

Lord Jenkin of Roding: My Lords, my noble friend has admirably set out the case in favour of the patient pack initiative and has raised a number of questions for

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the Minister to reply to. I share his concern that what started three years ago as an agreed, collaborative rolling programme, with the Department of Health giving what has been described as "unequivocal support", seems now to be bogged down because this Government are now refusing to make the necessary changes in the regulations. That is what is really required of them.

I only want to add three points to the case made by my noble friend. First, there really can be no doubt whatever that to give every patient supplied with a prescription drug a full information leaflet is of great benefit to all concerned. Patients and their carers now, perfectly reasonably, demand more information. They want a clear statement of the benefits and a note of the possible side-effects of drugs. They want advice on storage and on the length of the treatment. For their part, doctors can assume that every patient will get the required information in a readily understandable form, which he or she can study at leisure. It is well recognised that patients do not always remember what is said to them in the doctor's consulting room. Pharmacists can dispense in an easily identifiable pack with the information already enclosed. As my noble friend said, the system should reduce the quantity of loose tablets and capsules stored, not always safely, in bathroom cabinets at home, which should not only reduce waste but should prevent the accidental poisoning of children.

My noble friend mentioned the EU directive which will require us to ensure that essential information is provided to patients. If this is to be given effect to, the Government will have to take the steps necessary to ensure that this country complies. The patient pack initiative has until now been seen as the way ahead. My first question to the noble Baroness is this. Do the Government still accept this case; and if not, why not? If they do, why do they not get on and deal with it?

My second point--I am glad to see the noble Lord, Lord Winston, in his place--arises from the report published by the Select Committee on Science and Technology a week or two ago entitled Resistance to Antibiotics. There is much said in that report about the need to ensure compliance with prescribing recommendations.

I had the honour to serve on that committee, as indeed did the noble Lord. We said at paragraph 2.47,

    "The Royal Pharmaceutical Society has addressed this problem in a valuable document entitled From Compliance to Concordance".

It is a very interesting study. We went on to say,

    "The RCGP observe that compliance can be encouraged by drug and regimen design, and by patient information, on which there is recent EU legislation which they support. The ABPI are 'particularly keen' on improving compliance by means of new formulations; and they support the Patient Pack Initiative on patient information".

We have some fairly convincing evidence to support that statement in the report from the evidence presented to us by the Royal College of General Practitioners at paragraph 3.7. They said,

    "We also support better provision of written information and instructions to patients in line with recent EU legislation and we support the recent initiatives of the Royal Pharmaceutical Society of Great Britain in respect of compliance/concordance".

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The ABPI also gave us strong evidence. This is all in the context of avoiding the continuing build-up of resistance to antibiotics. They pointed out in their evidence that,

    "Antibiotic resistance is a global problem and"

needs "better education". They said,

    "The Patient Pack Initiative will ensure that all patients will receive a patient information leaflet with all their medicines. The leaflet for antibiotics will remind patients that they should take the medicines as prescribed and must finish the course even though they may well feel better. The reason for this will also be explained.

When the report was published the Government made it clear that they regard the whole problem as a desperately serious issue, as indeed it is. The committee was very alarmed by much of the evidence that we heard. I suggested that we might call our report, "How can we stop the bugs winning?". How can we avoid going back to the horrors of the pre-antibiotic age? The committee indicated that the patient pack initiative can help in that battle and yet here, almost at the first hurdle since the report was published, we have the Government dragging their feet and refusing to work with the industry and the professions to make the PPI effective.

My last point is that I believe it is really a matter of good faith. In 1995 the Department of Health, at ministerial level, gave the pharmaceutical industry what it describes as "an unequivocal assurance" that the scheme had the department's support. On the basis of that assurance, the industry has spent millions of pounds in gearing itself up in order to be able to implement the initiative only now to find, three years later, that the department is resiling from its commitment.

Therefore, I ask the noble Baroness how the Government will ensure compliance with the EU directive which, as I understand it, is binding on us and has to be effective by the end of this year? Can they not, even now, come clean and give the industry and all the professions involved, who support this initiative, as my noble friend made clear, the assurance that they, the Government, will play their part in implementing this initiative?

I regard this as a sorry tale of a government apparently reneging on a clear promise made to those with whom the 1995 agreement was concluded after 18 months of negotiations. It is not too late to make amends and I hope that the noble Baroness will tell the House this evening that that is exactly what they are going to do because I believe we should expect nothing less.

8.23 p.m.

Baroness Cumberlege: My Lords, I am sure that the Minister will have rejoiced with me if she saw the recently published annual report of the World Health Organisation which stated that more people reached the age of 50 in Britain than anywhere else in the world. Five years ago the WHO cited the Government's policy for the health of the nation as a model for other countries to follow. I would not for a moment claim that 18 years of Conservative Government is solely responsible for the healthiest middle aged population in the world.

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Likewise the pharmaceutical industry, which is recognised globally as being outstanding in its development and manufacture of therapeutic products, would not claim that it has been responsible for achieving this cadre of energetic and healthy 50 year-olds.

But I believe that we would all acknowledge that its contribution has been immense, not least in the field of HIV and AIDS, a field in which I know the Minister has extensive knowledge and expertise. It is wonderful to see these young people who were previously doomed to die, now living and working, leading almost normal lives, thanks to the ingenuity and the investment of drug companies in producing effective combination therapies.

However, medication, if not treated responsibly, can be exceedingly dangerous. As my noble friends have said, its use does require a partnership between patients, doctors, pharmacists, manufacturers, the MCA, the Committee on the Safety of Medicines and the Government.

Close working between all parties is essential and from the patient's point of view there is a very strong wish for better communication, as my noble friend Lord Jenkin has said, and a thirst for knowledge on the efficacy and side effects of the medication prescribed, which is, of course, why the patient pack initiative is so crucial. This in no way erodes the duty of care that doctors have in carrying out their prescribing, but it is essential for safety both in use and manufacture.

The Minister, after a year in government, will have discovered the difficulties of introducing any new initiative, especially where the Treasury has an interest. In my experience there is hardly a nook or cranny in government in which the Treasury does not have an interest.

My noble friend Lord Howe has raised the issue of costs so I am not going to go into those in detail, but simply ask the Minister, as he has done, on what basis the department has reached its figures. There is a suspicion that they are based on a worst case scenario and that in itself has been exaggerated. We really do not know whether there is a solid foundation for these estimates. I am not suggesting that the figures are at all false, but we need to know on what they are based. I did give notice earlier today to the Minister that I was going to ask these questions. I hope that she will be able to go into some detail to help us understand how the figures are made up.

The Minister will be aware also that the industry, frustrated by the Government's procrastination, has recently announced its decision to go ahead to introduce patient packs itself, and that is not surprising since it has invested many millions of pounds in this initiative. Therefore, it would be understandable if the Government felt that there is no need to lay the necessary regulations.

But there are two points that I wish to make here. The first is the safety of patients and, secondly, the European dimension. When the initial launch took place two or three years ago, there was strong support from not only the bodies which had a direct interest such as the BMA, the ABPI, the Royal Pharmaceutical Society and so on, but also from seven of the leading voluntary

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organisations: the National Osteoporosis Society, the Parkinson's Disease Society, the Depression Alliance, the National Eczema Society, the British Epilepsy Association, the National Asthma Campaign and the Patients Association.

I mention all these organisations because they are highly respected for their integrity and professional approach and represent a vast number of patients. These organisations have continued to campaign for the patient pack initiative on the grounds of safety, saving on wastage, non-compliance and repeat visits to the GP. They also make the very cogent argument that if the packs contain information on the availability of confidential helplines, they will be able to give advice and answer the queries which some patients find too embarrassing to ask their doctor.

Perhaps I may give an example of HRT for osteoporosis. I know that some women, once they are prescribed that medication, go home and then think, "If I am taking this drug and I have a period, will that mean I could get pregnant?" That person may be far too shy to go back and ask her doctor, whereas an anonymous osteoporosis nurse, at the end of a helpline, would be of enormous value in answering her concerns. I do believe that men taking HRT are not worried about this particular issue, but they also have very real worries. Information on helplines accompanying the medication, would be of enormous value to patients.

Since the pharmaceutical industry is going to introduce these packs and leaflets of its own volition, there is a danger that the Government may feel that the issue has evaporated. But that is a non sequitur as the pharmaceutical industry cannot cover all prescriptions and it will miss around 20 to 25 per cent. a year. In percentage terms this does not sound much but it represents about 125 million prescriptions a year which is a huge amount. That is why it is essential that the Government should produce the necessary regulations.

Both the ABPI and the Royal Pharmaceutical Society are anxious that some discretion should be built into the regulations so that common sense can prevail. With the cutting of packs there is no guarantee that leaflets will not be separated from the medication to which they belong. The cutting of packs anyhow is a nonsense if it can be avoided.

There are a number of very good reasons for the patient pack initiative, many of which have been or will be raised in the debate. But there is also the requirement referred to by my noble friend Lord Jenkin to comply with the European Council Labelling and Leaflet Directive which comes into force in January 1999. In a Written Answer on 12th December of last year the noble Baroness's honourable friend the Minister of State, Tessa Jowell, said:

    "We ... are considering whether it will be necessary to implement the European Council Labelling and Leaflet Directive by other means".--[Official Report, Commons; 12/12/97; col. WA 736.]

Can the Minister inform the House whether in the intervening five months the department has reached a conclusion on that matter? If there are other means can she outline them? Listening to those who are involved in this issue, there is a genuine desire to resolve it in

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partnership with the Government. Perhaps the Minister can be generous tonight and give an undertaking that her door will be open to all those who are anxious to see this matter concluded and that she will work closely with them in the spirit of partnership so extolled by the Government.

Dr. Peter Read, the recently retired and distinguished president of the ABPI, has stated:

    "Patient packs are the best, simplest and most convenient method of ensuring that patients get full details about their medicine. This has been standard practice throughout Europe for many years now, and I can see no justification for continuing to deny it to large numbers of people in this country".

I say amen to that.

Finally, I have a cutting from Tuesday's edition of the Daily Telegraph which bears the headline, "Ministers to get a 'school report'". The article went on to explain the plans drawn up by the Cabinet Office to monitor the performance of Ministers. None of us can have any doubt about the competence of the noble Baroness, but if she is to receive an alpha plus I believe that she must lay these regulations before the House. I believe that from the point of view of the National Health Service and those who are involved in this issue she will certainly get top of the class.

8.32 p.m.

Baroness Eccles of Moulton: My Lords, I am very grateful to my noble friend for tabling this Unstarred Question as not only does it give us an opportunity to discuss the important subject of the dispensing of drugs but also to touch on one or two of the wider issues relating to the part that drugs play in the health service as a whole. When the initiative on patient packs was launched in 1995, four advantages were highlighted--compliance, assurance, safety and effectiveness--and there can be little doubt that these are objectives worthy of support. The initiative also took account of the EC directive that came into force in 1994 which sets out in detail the information that should be available to patients when drugs are dispensed.

However, nothing is ever as simple as it may appear at first sight. At present, the majority of branded drugs are pre-packed and accompanied by the appropriate information. This is not always the case with generic drugs. One of the considerable impacts on the NHS drugs bill is caused by the difference in cost of branded and generic drugs. If every generic drug were blister-packed, for instance the 75 milligrams of aspirin which is taken to prevent coronary heart disease, the cost would become prohibitive. On the other hand, there are other drugs where the advantages of pre-packing outweigh any additional cost that may be incurred; for example, where medication is prescribed for high blood pressure. Hypertension is asymptomatic, but the drug therapy can make the patient feel dizzy and unable to sleep at night. Compliance is essential to prevent further cardiac problems and other organ damage. A patient pack which has the days of the week printed on it would encourage the patient not to miss a dose. Therefore, it is very important that the campaign to provide drugs in patient packs where this is known to have considerable advantages is vigorously pursued.

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My noble friends Lord Howe, Lord Jenkin and Lady Cumberlege have emphasised most effectively the importance of the patient pack initiative. Rather than repeat what has already been said, I take a minute or two to describe a pilot scheme involving regular repeat instalment dispensing which is now running in Ealing, Hammersmith and Hounslow Health Authority of which I am chairman. This is one of five schemes supported and funded by the Department of Health. The scheme has several purposes: first, to involve the pharmacist more directly in the continuing drug treatment of individual patients; secondly, to increase compliance; and, thirdly, to prevent waste. In the authority nine GPs and 240 patients have been recruited to the pilot scheme. Our pilot is slightly different from the other four in that patients may take their prescriptions to any pharmacy in the three boroughs. This means that there is 100 per cent. participation in the scheme by pharmacists, although those who operate within the catchment areas of the nine practices will obviously be most involved.

Under present arrangements, if medication is prescribed for six months the patient is usually issued with a prescription for one to three months, depending on individual practices' repeat prescribing policy. The patient will then go back to reception at the surgery for a repeat for a further three months without necessarily seeing the GP.

Under the pilot scheme, the difference is that the patient is issued by the GP with an initial prescription and five repeats, all with a distinctive identification. As each prescription expires, the patient returns to the pharmacist and together they complete a patient assessment form. The next month's medication is then issued and this is repeated until the six months are up. If the patient is having problems, these are discussed with the pharmacist who can take one of three courses of action. He can try to persuade the patient to continue with the medication, or agree with the patient that it is right to stop the medication, or refer the patient back to the GP. The pharmacist receives a fee for each intervention and the trial runs for six months.

The data that has been returned so far from the Prescription Pricing Authority indicates that already savings can be identified. However, it will not be until October, when data covering the whole of the six months is received and analysed by the authority, that it will be known what effect the scheme has had on the prescribing pattern. After the project ends in June there will be meetings with patient and GP focus groups and a full report will be written up by the beginning of next year.

Already a number of benefits can be identified. For instance, the scheme creates an incentive for pharmacists to monitor medication and not issue drugs where that is inappropriate. It also has benefits for the patient. Regardless of whether or not it is rolled out nationally when the results of all the pilots are known, it is a system which would lend itself very well to being operated by individual primary care groups. The co-operation and enthusiasm that patients, GPs and pharmacists are all demonstrating is most encouraging.

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I have spent some time describing this pilot, although it is not directly connected with patient packs, because it is another way of increasing patient understanding of the drugs they are taking and compliance with their drug regime. It seems to me to be a very good way of increasing the involvement of our highly skilled body of pharmacists in direct patient care.

Although waste has already been referred to, I should like to remind noble Lords that 10 per cent. of the total NHS budget goes on funding drugs. Historically, this percentage has been rising despite the rise in the total NHS budget. Of all drugs issued, 64 per cent. are for repeat prescriptions. Of that 64 per cent. it is calculated that 50 per cent. is wasted. This is a staggering amount. Any initiative which not only reduces waste of NHS funds but increases patient compliance--non-compliance has the double effect of reducing benefit to the patient and wasting resources--must be vigorously pursued.

My noble friend Lord Jenkin used the word "concordance". It has been drawn to my attention that that word should now be used instead of "compliance" because "concordance" more accurately reflects a sense of partnership and co-operation between patient and doctor or pharmacist.

Another factor that increases pressure on the budget is the coming on stream of expensive new drugs. This is probably occurring on an unprecedented scale. For instance, my health authority has recently received a request for the funding of a new drug with life-saving properties to treat a rare condition. At the moment, that drug could cost up to £300,000 per year per patient. The benefits to the patient versus equity and opportunity costs are still being calculated in this case. New drugs such as Orlisat for the treatment of obesity, and the much publicised Viagra, will add to funding pressures and difficult decisions which could involve rationing will have to be taken. Progress in drug technology is controlling hitherto uncontrollable symptoms and extending life. At the same time new drugs are becoming available at ever-increasing cost to the NHS.

There is so much that can be done to advance the four factors set out in the case for patient packs, with considerable benefit to patients, but also with the effect of directing the budget in a way which prevents waste. I hope that all sensible proposals will be listened to, and pilots that prove successful will become widespread practice.

8.40 p.m.

Baroness Thomas of Walliswood: My Lords, in the absence of my noble friend Lord Alderdice it falls to me to welcome the debate which has been stimulated by the noble Earl, Lord Howe's Question.

I come to this matter with a lack of prejudice born of ignorance. I have become increasingly sceptical as I read the sort of material, which has clearly been used by other people, about the Minister's stated reasons for putting into question the introduction of patient packs to which the previous government committed themselves in 1995. It is bad practice in this kind of case to renege on commitments made by previous governments.

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Obviously you cannot keep everything, but if you have a situation where large numbers of partners--including the companies which produce the drugs--have been involved in taking a decision, which has been confirmed by the department, and has resulted in them taking actions affecting their own businesses, and then the whole thing is put into doubt, it is a marginal case but it is not an attractive way of conducting government.

This is particularly so in the case where the Government have committed themselves to the standing programme of their predecessors which contained, no doubt, an element for the expenditure which it was then anticipated would be involved in pushing this initiative further. There is a question over this whole action.

Earlier speakers, the noble Earl, Lord Howe, the noble Baroness, Lady Cumberlege, the noble Lord, Lord Jenkin of Roding and the noble Baroness, Lady Eccles of Moulton, have all made out very clearly the advantages of this particular approach of patient packs. Without going through it all in detail, it aids prescription and dispensing of medicine. The packs provide not just the right dose which the patient requires, but the information which enables the patient to take control of his own use of that medicine and to understand why he should complete the course. That is a particularly important point which the noble Lord, Lord Jenkin of Roding, made because of his particular knowledge. The need to complete courses of antibiotics is something of which some of us are aware, but many people are not.

There is a safety element in the home in that it reduces the amount of left-over and unlabelled bits of medicine lying about in people's houses. There is an element of the reduced cost to the health service in as much as there is greater efficiency in the dispensing of medicines, in the prescription of medicines, and there is therefore less waste.

Dispensing chemists are not obliged to spend large proportions of their time counting pills and can therefore spend more of their time performing the other part of their job which is advising the customers who come to their shops and counters for their prescriptions as to how they can best use the information and the drugs with which they are being supplied.

Noble Lords would not expect me to underestimate the importance that the use of such packs would have in enabling the UK to comply with the 1994 EU directive on drug labelling and leaflets, an initiative which the previous government supported. This could ensure that the UK met the deadline for that compliance.

A number of reasons have been put forward as to why the Government might have changed the approach of their predecessor. The one that strikes most strongly is the question of cost. Is it the cost of £60 million to £67 million over four years which has deterred the Government from continuing with this agreed approach to solving a particular range of projects? I have seen some material with some information about government costs in this connection--obviously that material is not very detailed--and I support the questions asked by other people about what the basis for these calculations has been.

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I spent 12 years in local government and I learned--as many hundreds of thousands of people have before me and, no doubt, many more thousands since I left--that when you read a paper provided by officers you should ask yourselves not only whether you agree with what is in that paper, but what has not been included. When you are providing a rationale for taking or not taking decisions, normally the officers provide a cost benefit analysis. The financial benefits of this particular approach have been clearly outlined by the noble Earl, Lord Howe; I will repeat only one of them. If clear labelling of all the generic medicines, and the accompanying of those medicines with the correct information, were to increase the proportion of generic medicines prescribed by only 1 or 2 per cent., you would much more than offset the cost, on an ongoing basis, of the introduction of this pack system. One has to ask why the cost benefit of this new system has not apparently been considered, at any rate not recently.

My second question is directed at the value-for-money concept. Even if there are some costs associated with the patient pack approach, is not the value which the approach brings worth at least some cost? We are not talking about better value for no money at all but better value for money in public services.

My final question is if the Minister is unable to reassure the House that the patient pack initiative will go ahead in a co-operative way between the Government and other partners rather than by the decision of one partner how do the Government propose to meet the EU directive in time and in an orderly fashion?

8.40 p.m.

Baroness Jay of Paddington: My Lords, I am very grateful to the noble Earl for raising this Question and to those other noble Lords who have taken part in this short but nonetheless interesting debate.

The brief answer to the noble Earl's Question is that the Government, of course, support the intentions of the European labelling and leaflet directive. We particularly always support provisions which enable patients to have a better understanding of the treatments they are being offered and, in the case of medicines, the medicines that they are using. However, we do not support the details of the complex and costly plans developed by the previous administration, which have become known as the patient pack initiative. The present Government cannot justify diverting large sums of money from the NHS budget to meet the additional costs involved in these plans. We believe, to put it simply, that as far as possible NHS resources should be spent on direct patient care.

I find it somewhat extraordinary that the noble Lord, Lord Jenkin of Roding, and the noble Baroness, Lady Thomas of Walliswood, should be surprised and see it as almost politically unacceptable that the Government should change health service policy in this area. I am almost tempted to ask them whether they regard it as dishonourable that we move to dismantle the GP fundholder system in which many people under the

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previous administration had a vested and large interest and under which many commitments were given by the previous government--

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