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Patient Packs/Dispensing Costs

Volume 407: debated on Tuesday 24 June 2003

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4.10 pm

This may seem a rather mechanistic and narrow subject for an Adjournment debate, but it is an opportunity to reflect on a subject that is of great concern to a number of key constituents of most Members of Parliament. It is also a matter with a great deal of history behind it.

I want to cite a presentation made to the British Pharmaceutical Conference in Llandudno in September 1958 by Mr. Chamings, a former head of the Leicester school of pharmacy, setting out the basis for original pack dispensing of pharmaceutical products. An article from The Pharmaceutical Journal describing his contribution states:
"In his talk, Mr Chamings said that the use of proprietary medicines in manufacturers' original packs had reached the level of 80 or 90 per cent. in continental Europe and North America. This, he said, 'points to the inevitable in British medicine' although, at that time, the average in Britain was around 50 per cent. Famously, he pulled a continental pack of medicine from his pocket and asked: 'Why can't we do it like this?'"
But to take a little bit of more recent history, the same article, quoting The Pharmaceutical Journal of 18 June 1983, said:
"The breaking of bulk"—
bulk in this sense means bulk packages of pills or other prescription products—

"to meet prescriptions has resulted in an anachronistic cottage industry within pharmacy."
We have clear evidence that for many years it has been recognised that the practice of taking a large number of pills in bulk and then putting them into a separate pot or package for passing on to a patient is inefficient, anachronistic and carries certain other risks. During this short debate, I shall develop the argument that we should at last bring that process to a conclusion in this country.

For those of us who obtain prescriptions from a pharmacist, blister packs are the commonest way in which we see a product. They are safer and have a quality control placed on them that is far greater than the bundling of pills, however carefully done, by a pharmacist in a back room. The integrity of the pack is retained. The expiry date is clear. There is a batch number that allows the product to be traced back to the manufacturer. There is a clear description of the contents and the quantity, which is displayed clearly on the pack.

There is a small pharmaceutical manufacturer in my constituency, and I am pretty sure that my hon. Friend the Minister has a much larger one in her constituency. When visiting the site, I am always amazed by the absolutely understandable and obsessive concern with quality control that ensures that what we get in the pack passed to us by a pharmacist is exactly what we need. The quality control involved in the preparation of the individual pill and packaging it into whatever receptacle is used by the manufacturer is critical to that process, and to the manufacturer's achieving a licence to do that task at all.

Let us compare that with what happens in a pharmacy, in which people take the product in bulk and handle it however best they can into the receptacle that they are going to give to the patient. Imagine the process continuing in the home of the patient. The patient could have a bottle of pills, which is pretty rare nowadays, or a split pack, which is quite common and which involves someone being given one pack of a product plus a cutoff piece of foil from another pack to make up the correct quantity. That method of quality control is far inferior to that of dispensing a complete pack as produced by the manufacturer. No one would argue that using the original pack from the manufacturer is not the safest and the highest quality way for a pharmacist to meet a prescription requirement.

Using the original pack also improves compliance in relation to the product. One of the critical issues, which we are increasingly coming to recognise, is that health is a contract between various parties. Critically, one of them is the patient. Patients have to be persuaded that they need to complete the course that they have been given by a pharmacist. They expect accurate information and easy to remember ways in which to check whether they have taken the product that they are supposed to on a certain day. Those things are innate when using the original manufacturer's packs. It is far harder to be confident about compliance when there are split packs or products that are sourced direct from the pharmacist from bulk products supplied to him or her.

The process is also immensely wasteful and time-consuming. The classic example is when a pack is available in 28-day units, but the doctor has prescribed a course of 30 days. Someone takes the 28-day pack and snips two days off another pack, leaving a 26-day pack. Unless another patient comes in and another two days are snipped off, those items are unlikely to be used, and the risk of damaging the product in the process of snipping it up is quite significant. Why can we not have either 28 or 30 days—we need to define what we mean by a month of treatment—and pack in a uniform, standardised form?

As the answer to my parliamentary question of a few weeks ago revealed, at the moment, the national health service pays between £5 million and £6 million a year to pharmacists to compensate for packs that are broken into and thrown away. That is a waste of public resources. We should be addressing the matter anyway and hoping to improve our performance.

Dispensing in broken packs also takes more time. If someone is fiddling around trying to cut the correct number of items up to put in an envelope to go with the complete pack, that will take longer. Worse still, that person has to comply with European Union law and provide a leaflet to go with the small number of additional pills. If there are no spares in the pharmacy, the Department of Health kindly provides xerox machines to allow people to copy the leaflets and hand them out to those who receive a prescription, but there are doubts about the legality of that process. Surely, it is an obtuse response to a matter that should be addressed by examining the most sensible process to address a need, rather than trying to find bodge-it and fix-it methods of dealing with inadequacies.

The process of monitoring the dispensing of products is immensely costly. Again, a question to the Department of Health about a month ago elicited the fact that between 1990–91 and 2002–03 the cost of the Prescription Pricing Authority—the people who process the scripts that go through a pharmacy—has increased in real terms by £18 million. That is ignoring inflation and I was careful to ask the question in that way. That is largely a reflection of the increased number of prescriptions that are being given out to people—something that we all must accept.

Nevertheless, it is fair to say that, when pharmacists examined the remuneration paid to them during the same period for each prescription dispensed, they established that in 1990–91 the figure was £1.39 for each prescription, and that in 2000–01 the figure had dropped to £1.05. Therefore, it is one-way traffic. We expect greater and greater efficiency from pharmacists, and, as I have said, we can improve their efficiency, but the cost of the bureaucracy and processing regime that the Government maintain to support the paperwork has continued to escalate and, indeed, has not demonstrably improved its performance in unit costs over that period, as the answer to my question showed.

Having chosen the subject of this Adjournment debate, I received some comments from interested parties on the matter, and I want to quote from one of them. I refer to the organisation that produces drugs that have gone beyond the point at which the major manufacturers continue to protect their rights. Such drugs can then be bulk produced by anyone with the appropriate licence. The British Generic Manufacturers Association said that it would be very happy for me to confirm in my speech that it
"fully supports the introduction of patient packs as the normal presentation for prescription medicines."
It also said that it is happy to discuss the way in which it could standardise the numbers in the packs. Obviously, it could be 28 or 30; there are arguments either way. There could even be some differences between products. However, the sensible approach would be to make sure that we understood what unit we were using.

I also read some of the comments made by the patients. The pharmaceutical press has been running a campaign on the issue recently, and among the contributors was Epilepsy Action, which referred to examples of products that it had been shown that had been dispensed to people to meet their needs. One bundle came from a woman who had been given four different packs from different countries and by different manufacturers supposedly containing identical medicines. Epilepsy Action even received reports of people being given mixed bubble packs in the same box. Any steps that can prevent such things from happening will be welcome.

There is a consensus that we are adopting a low-quality approach, which also has significant inefficiencies within it. What can we do about it? It is not a new subject. Indeed, Governments—I use the term generically—have already accepted the need for progress towards the provision of patient packs. Until November 1997, various parts of the industry were co-operating with the Government towards an agreed plan that would make all products available only in patient packs by 1999. However, minor difficulties with modest cost implications emerged—I have referred to the fact that we spend about £5 million to £6 million a year on broken packs, and additional photocopiers were provided to all pharmacists at a cost of about £500,000. 'The relatively small-scale costs of progressing through to the conclusion of the patient pack programme are between £5 million and £10 million a year. Those cost implications put off the Department of Health, which aborted the project.

We are therefore left with a continuing legacy of packs of various sizes, and with some products not in patient packs at all. That results in confusion for GPs, who have to remember exactly what quantities they are supposed to prescribe; pharmacists, who have to fumble around and try to remember the correct quantities; and patients, who are left with an unsatisfactory bundle, sometimes of pills in different shapes and sizes.

The approach of giving greater freedoms to the different nations of our country has resulted in some useful initiatives. In Scotland, an experiment is under way that allows pharmacists to dispense to the nearest quantity of an available patient pack. Therefore, when a doctor prescribes for 30 days, but the pack is for 28-day, the patient will get a 28-day pack. That seems a modest and intelligent approach that we should adopt in the UK as a whole.

There are some small exceptions. There are some items that we would not wish to see in 28 or 30-day packs. Those have been identified in the exercise that I have referred to, and consensual ways forward have been agreed. Some say that the flaw is that one cannot apply the scheme to antibiotics or antihistamines. I agree with that, but we can address that matter intelligently while maintaining the integrity of the patient pack initiative.

The scheme is an idea whose time probably came about 45 or 50 years ago. Our time-warp approach leaves us offering a less efficient and less safe service than would be experienced by patients in other countries. The negotiation of the new contract for pharmacists should finally start to prod us into the modern age. I emphasise that we are prodding at an open door. I had a meeting with local pharmacists in my local area, and they are keen to make progress. One very active local pharmacist in my area, Michael Everitt, runs a pharmacy in Castle Gresley and regularly calls me on pharmacy matters. They are keen to see us make progress. They recognise that it is a legitimate part of the negotiation of pharmacists' contracts. Therefore, I very much hope that the Minister will be able to give some indication of the Government's commitment to bring this long-awaited project to its conclusion.

4.29 pm

I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on his success in securing a debate on this important issue. We greatly value his interest in health and health care issues and, in particular, his contribution to the all-party parliamentary group on pharmacy. He is a staunch and knowledgeable proponent of the role that pharmacists can play in the health, and indeed the life, of the nation. He has proved that by his words this afternoon.

This country has the benefit of a highly educated and trained pharmacy work force. I share with my hon. Friend a conviction that we must use those skills and knowledge to best effect. The Government have made clear their commitment to sustaining and further developing the important contribution made by pharmacists in modernising NHS services for patients. The debate about patient packs is about the safe, accurate and efficient handling of more than 600 million prescription items a year.

However, there is sometimes a misunderstanding of the Government's position on patient packs. We are fully supportive of the use of patient packs, and we have never in any way opposed their manufacture or use. We accept that there are advantages to the use of patient packs. Our reservations are about the appropriateness, practicality and cost of moving to a situation under which complete patient packs are the only form in which medicines are prescribed by doctors or dispensed in community pharmacies. We are yet to be convinced, as some are, that the exclusive use of patient packs represents the only way of complying with the European directive on labelling of medicines and patient information leaflets. Nor have we been convinced that there is a simple, cost-effective or even desirable way of mandating that patients receive their medicines only in complete patient packs.

Switching to patient packs sounds a simple idea, but in fact it raises complex and difficult issues. Hon. Members might think that doctors should be strongly encouraged to prescribe in standard pack quantities, but standard packs do not necessarily contain the quantities that doctors prescribe, or that they believe they need to prescribe.

I am listening with care to what the Minister says. I quoted the experience of my constituent who told me that he would regularly ring up a doctor to say, "You said 28, but in fact they come in packs of 30"—or vice versa—"and do you mind?" He said that he had never heard of a doctor saying, "No. I want precisely that quantity, not what you've just said." The difficulty is not that doctors want to prescribe a different quantity, but that there is a lack of knowledge of the precise pack quantities with which they are dealing—understandably so, as doctors have many other things to think of.

I appreciate my hon. Friend's point, but he is talking about a small variation. There might be much wider variations in the numbers that doctors want of something. The pack size might be for 14, 28 or 30 days, although somebody should be given a particular drug for just a couple of days. There are situations other than that which he is envisaging that might pose more problems for the argument that he advances.

We could insist that pharmacists dispense complete patient packs, even if they contain more or less than that which has been prescribed. The question then is, what if the quantities in those packs are inappropriate for the patients who receive them? It might not be a question of two days, but of a considerable variation. On the argument about cost and paying for the medicines, discarding the excess part of the packs before dispensing could mean the NHS paying for medicines that will inevitably be wasted. 1 appreciate that my hon. Friend and I share the same interest in the efficiency of the system, getting the best value for money and minimising waste. We must consider the best way of taking that forward.

It is true that pharmacies can claim so-called "broken bulk" payments for the remainder of packs that they cannot use, but that applies only to residues that cannot be used up within six months. It does not routinely apply to all packs that are split. Even if we could agree that prescribers should prescribe, or pharmacists dispense, standard pack sizes, we would have to decide what is a standard pack. Different suppliers supply different size packs for the same product; clearly, different GPs have different ideas too. We could impose standard pack sizes, but we do not see it as the Government's job to tell the pharmaceutical industry what pack sizes to make. In any event, and as my hon. Friend said, there is trade in medicines across the European Union, and any attempt to impose special UK pack sizes would be likely to breach EU rules on the free movement of goods.

It was largely because those various issues had not been addressed properly that we decided against continuing the previous Administration's patient pack initiative. The proposed arrangements were highly complex, and important details had not been agreed. Contingency arrangements were missing, and we calculated that the initiative would have diverted up to £60 million from direct patient care during the first three years and £15 million each year thereafter. That calculation was based on earlier figures, so it is not a current costing.

Our decision on the patient pack initiative indicated no lack of commitment to ensuring that patients receive medicines in a safe, appropriate and convenient way, accompanied by the correct information leaflets. We have explored several ways in which pharmacists and others can be helped to comply with the requirements of the European directive and it was in that spirit that we put forward a package of measures last August.

First, we issued guidance reminding pharmacists of their obligation to provide patient information leaflets. The guidance acknowledged that there would be circumstances in which pharmacists would have to dispense either from bulk supplies or from split patient packs. The guidance made it clear that the best approach by far in such cases would be for the company marketing the medicine to supply sufficient copies of the original leaflet. Failing that, pharmacists might photocopy leaflets or download them from a reputable electronic source.

Secondly, while acknowledging concerns about copyright, we opened consultation on a proposal to provide a statutory defence for pharmacists who copy leaflets for the sole purpose of complying with the law. We also offered to make a one-off payment, of £500, to community pharmacies to help to meet the costs of gearing up to comply with the law.

Thirdly, we said that we would consider with interested parties the possibility of allowing a certain amount of rounding of prescriptions, so that, in the case in which my hon. Friend was interested, for example, prescriptions calling for 28 tablets to be dispensed might he met by packs of 30 and vice versa. We also said that we would explore with the National Prescribing Centre and primary care trust prescribing advisers what actions might be appropriate to promote prescribing practices that would facilitate the provision of patient information leaflets.

The consultation on the proposal to provide a statutory defence to permit pharmacists to copy leaflets provoked considerable interest. The Medicines Control Agency, as it then was, received some 130 responses. There was, of course, significant support for the principle of written information with medicines, but it is fair to say that many respondents expressed disquiet about the particular mechanisms discussed in the document. In relation to the statutory defence itself, some respondents were in favour and some were against. Inevitably, responses addressed wider issues about patient packs and the provision of leaflets. In particular, pharmacy and pharmaceutical industry bodies expressed considerable reservations about the appropriateness and practicality of photocopying leaflets and argued forcefully that the only feasible way forward is patient pack dispensing.

We are, of course, giving those views and all the other responses that we received careful consideration, but two important points remain. First, the notion of patient pack dispensing is not, in our view, as simple as it is claimed to be. As I have explained, we do not believe that there is a ready-made, cost-effective solution simply waiting to be taken down from the shelf. Secondly, even if such a solution existed, the present reality is that medicines in this country are frequently dispensed in part-packs, whether from bulk supplies or from patient packs. It is clearly preferable for companies marketing medicines to provide sufficient copies of original leaflets for pharmacies to use, but if they do not, surely it is better that pharmacists photocopy or download leaflets than that patients receive no leaflets at all.

No-one would deny that there is a case for looking at how we can avoid the unnecessary splitting of patient packs. As I have said, we have already signalled our willingness to talk about ways of facilitating the greater use of complete packs by permitting rounding between 28 and 30 packs. That will be done in the context of our overall desire to simplify the rules governing the reimbursement of medicines dispensed on the NHS.

I referred to the increasing efficiency of pharmacists. A parliamentary answer showed that over the past 10 years pharmacists have been asked to dispense more products for the same mount of money or thereabouts. Does the Minister accept that the present round of negotiations with pharmacists, particularly in the context of the OFT report, is an opportunity to tie up some of the issues and provide a real gain in terms of patient quality outcomes rather than just addressing it in terms of whether we shall photocopy some leaflets?

I agree with my hon. Friend that it provides an opportunity for such matters to be discussed further. I undertake to investigate whether the matter is being included in the discussions in any way, shape or form. However, I am sure that my hon. Friend will accept that it is not just a matter of community pharmacists negotiating with the Government. The views of GPs, hospital and pharmacy services, those writing prescriptions in a hospital setting, the pharmaceutical industry and the patients must also be involved.

It being twenty minutes to Five o'clock, the motion for the Adjournment of the sitting lapsed, without Question put.