A major, nationwide trial of medicines management is soon to take place in England. The editor of The Pharmaceutical Journal (Mr Douglas Simpson) asked Mr Allen Tweedie (the chairman of the profession's leadership group on medicines management, right) to describe the trial and to explain what he hopes the trial will achieve
Douglas Simpson: What is the form of medicines management that is being developed in Britain?
Allen Tweedie: The medicines management system which we are developing is based upon a new partnership between pharmacy and medicine to manage the therapeutic effectiveness and economics of treatment, in order to deliver better patient outcomes. That is the broad objective, but there are detailed elements dealing with things like adverse drug reactions, interactions, compliance, and so on.
Which types of patient will be covered initially by your system?
Initially, the service is primarily directed at those patients who are the biggest consumers of medicines - the chronically ill. But, of course, any intervention that needs to be made for them in respect of an acute illness will be picked up in the medicines review system which is to be used.
Which categories of chronic illness will you target?
We will focus on one of the Government's prime areas of concern, namely, coronary heart disease.
So, you will not be moving into any areas like diabetes at this stage? In the long run, do you expect to be focused on chronically ill people generally?
Yes, we do. But, in order to structure a research project which can give definite outcomes, we need to focus on one particular disease area. But, in the fullness of time, and indeed while this trial is going on, we will be developing a medicines management review process for other disease areas such as diabetes and asthma.
And what will pharmacists actually do for these patients?
First of all, with the collaboration of the doctors who will be part of this trial, there will be a review of the patient's relevant medication history, and a review of the medication which they are taking and effects they are having. Particular attention will be paid to any adverse effects because they affect issues such as compliance. Patients frequently, for all sorts of reasons, become non-compliant. So we will be looking at things like commitment to therapy and some of the issues which might deter people.
Simple things like the taste of a medicine, the shape of a tablet, difficulty in swallowing can all affect compliance.
Will any attempt be made to confirm that the right medicine has been prescribed for the patient? There is no point in being compliant with the wrong medicine.
That will be covered in the review. In the initial review of the medicines which the patient is taking, the pharmacist will be discussing with the doctor the prognosis of the disease, and the medicines being used. Then the pharmacist can tease out some of the issues in further detail with the patient. This will enable the pharmacist to make recommendations to the doctor about any adjustments which could be beneficial to the patient, bearing in mind also the economics of treatment.
Will the pharmacist be giving any kind of care plan to the patient and telling the patient what to expect from their medicines?
This will be a very important part of the discussion between pharmacist and patient. The patient needs to be given more knowledge about their medicine and hopefully from that will arise more commitment to the regimen.
And will the pharmacist follow up to make sure the treatment is working for a particular patient?
Yes. Review dates for the medication and medication changes will be agreed and the patients invited back to discuss what has happened since the last interview. This whole project is about collaboration and partnership with the other health care professionals.
So, in summary, with the doctors and other health care professionals, the pharmacists will help to make sure that any medicine a patient is taking is the right one, in the right dose, and that it works. If it does not work, something will be done about it.
That is exactly right.
That is quite an onerous role for the pharmacist, so what training will they need to perform this function? Are they going to have any special training for these pilot trials?
Yes. There will be a comprehensive programme. We have just had a meeting at the Society on the education and training needs of the trialists. Later, of course, we will need to think about traditional training for the profession. Training will revolve around the pharmacology of the drugs used in coronary heart disease, the economics of the different treatments and communications issues. Communication issues are particularly important and they will be addressed in a thorough training package. Training modules are currently being evolved by the bodies in pharmacy which are well accustomed to this, such as the Centre for Pharmacy Postgraduate Education.
And what about the documentation or IT systems that will be needed to be set up to allow pharmacists to perform this function? What are the plans in that respect?
Initially, the system will be paper driven. There will be recording forms for each stage of the process, that is to say, the discussion with the doctor, the pharmacist's medication review with the doctor, and the pharmacist/patient interaction, including patient feedback. In tandem with this, we are looking at IT packages which ultimately of course will take over.
Electronic systems have been developed in America, Australia and New Zealand. Will you be using any of these?
The various models will be looked at and possibly some might be used. Equally, if we can source systems locally we will do so.
What day-to-day support, professional or otherwise, will pharmacists need to help them to be effective in this role?
A research team is to be appointed, which, with the project manager, will open lines of communication to the trialists on a day-by-day basis. When a pharmacist feels the need for assistance, he or she will be able to ring up and talk to an appropriate person.
Will that cover help with the pathology of the disease or the treatment of the disease? Will it be that kind of technical help that is available?
Yes, it will. I should add that this will be a trial that will be refined as it goes along. In American terminology that is called action research. But we aim to finish up with a developed model of service which can then be rolled out for the whole profession.
You mention a project manager. Have you got one?
Yes, indeed. We have an excellent project manager in John Dixon, who already has done an enormous amount of work.
He has been responsible, together with the project team, for finally putting together the submission to the Department of Health. This is a joint project with the Department. John's expertise is in managing projects and drawing together all the various strands of what is required.
What, if anything, will be needed to be done to pharmacists' premises to fit them for this function?
We have had a number of designs produced. These reflect the need for private consultation with the patient. I don't mean being locked away in a room, but having an area which is private and which is not accessible by general members of the public. There will need to be a bench facility of sorts and provision for IT.
The project team and the research team will decide what is appropriate in each particular premises and those facilities will then be installed. Pharmacists will not be charged for this. The cost is being built into the research proposal.
Will pharmacists need more staff to perform this role and will any such staff need training?
Staff will be required to release the extra resource which the pharmacist requires, which, of course, is time. To achieve that, certain of the duties which the pharmacist currently undertakes will need to be delegated to properly qualified technicians. This is something that will be looked at in the trials.
Will there be any remuneration for participating pharmacies?
Yes. The level of that, of course, is still to be agreed but proper costings have been made and this has all been built into the research submission.
What is the shape of the trials?
The format will be that of a "before and after" trial. A cohort of patients will be selected and they will be reviewed without any intervention at all to establish a baseline covering their treatment, how they are feeling and all the other relevant issues. Those same patients will be reviewed after the intervention. There was a possibility at one stage of trying to have a cohort of patients as a control. That has been held to be not satisfactory because you can never get one cohort of patients which exactly mirrors another. We felt it was better to look at the patients as they are now and then look at the same patients after the intervention. In that way you have got an exact measure of what has happened and what is different.
So, presumably, you are going to have some kind of pathology or some kind of disease state benchmarked to help you decide whether the patient is better or worse. Is that the way it is going to work?
That is absolutely right.
Who is organising these trials?
The trials will be organised by the research team and the project team. We are looking at the moment at 10 geographical localities in England which are likely to contain something like 30 GP practices. The practice size may vary from, say, two doctors up to five. It is likely that 70 or more pharmacies would be involved and the cohort of patients which we are suggesting would be of the order of 3,500. There is a possibility that the trial could be quickly extended to Wales.
So this is a very large trial, is it not?
Yes, it is. This is a very serious attempt by the Department of Health and the profession to look at an issue in a comprehensive, structured way so that we can make proper deductions and assess what the effect of this would be if it was implemented on a profession-wide basis. This is about really re-engineering the place of pharmacy in primary care. It is as big as that.
From where is the project team drawn?
What we have tried to do from the very beginning is to ensure that this was a profession-wide initiative and that all the leadership bodies in pharmacy were involved. The project team is drawn from the Royal Pharmaceutical Society, the National Pharmaceutical Association, the Pharmaceutical Services Negotiating Committee, the Company Chemists Association and the Co-operative Pharmacy Technical Panel. All these organisations have come together in this unique collaborative project.
If we can deliver what our initial review shows that we can deliver, this really will mean a historical change for the role of pharmacy.
What is the hypothesis that you are testing?
It is that the addition of pharmacists to the primary care team in collaboration with doctors is able to deliver measurable differences in patient care, patient outcomes and the economics of drug prescribing.
You mentioned an initial review. What was that?
The University of Aberdeen did an excellent job in reviewing the literature and various studies which give a very strong clue about certain elements of the intervention which we are designing. What has not been done so far is that all these elements have been put together in one big trial.
Will there be any piloting involved before you start this trial?
No. We believe we have sufficient experience from previous smaller trials which have been held on elements of this to know the sort of things we need to be doing and we are going straight into this major trial. All in all, the trial is likely to take two years.
When will it start?
It will start this year, just as soon as we can get organised after we hear what the Department has to say about the allocation of funds.
What will the trial cost?
We estimate between £1.5m and £2m. We do not believe that this is a large sum of money in the grand scheme of things, when you consider that community pharmacy since 1990 has delivered something like £6bn worth of savings for government in discounts.
How will you find a research team?
An advertisement has been placed in the European Research Journal to invite interested parties - university researchers and so on - to put forward proposals. We will select the proposal which most nearly meets our requirements. There may well be collaborative teams from medicine and pharmacy. The evaluation will be done by a separate team. We believe it is important that the evaluation of this study is kept separate from the actual study intervention and research intervention itself. We will advertise for the evaluation team later.
When will you be inviting pharmacists to put their names forward to participate?
As soon as we can. We will be looking at people who want to be committed to this process and that will probably occur before mid-year. We are now dependent on the button being pressed by the Department of Health.
Are you happy with the level of support from the profession and the Government?
The collaboration profession-wise has been first class. Initial difficulties we had in communicating and getting the various groups together have now been overcome. There is now a dedication in all parts of the profession to get this system up and running and to make it work.
The Department of Health has been absolutely excellent. It has given this first-class support from the beginning. In fact, the project is probably unique in the sense that it is a pan-profession project in which the Department of Health has had a say virtually from day one. It is part of our management team.
Assuming the trials are successful, when can we expect general application of medicines management?
General application is at least two years away but that does not mean that certain aspects of medicines management could not be brought in before that. We will be looking at the results as they come in. Where elements are being demonstrated as valuable straight away they could be brought in well before the end of that two-year period.
Any ideas what they might be?
They could revolve around the economics of prescribing. The PSNC is working on a package now. Doctors are asking us for assistance of various sorts in regard to their drug budgeting. This really is a major opportunity for pharmacy to build right now a basis of trust with the medical profession so that when full medicines management comes along it will be a natural extension of that process.
Why do you use the term medicines management? The process you were describing to me earlier is pharmaceutical care in the sense the pharmacist evaluates the treatment that the patient is on, talks to the patient about the treatment that he or she is getting, tells the patient what to expect from the treatment, then follows it up to see if the treatment is working and does something about it if it is not. That is the classic pharmaceutical care process.
I would certainly have no objections whatsoever to the use of the term pharmaceutical care.
The Aberdeen review covered both terms and treated them as synonymous. However, at this moment in time we are not pressing the issue of a complete pharmaceutical care package, because, at the end of the day, we still regard the doctor as the lead in patient care. But, whatever term is used, it does not alter the fact that we will be bringing pharmaceutical expertise to bear in collaborative partnership with the medical profession to deliver the best outcome for the patient.
How important is this project to the profession?
Here is a major opportunity, backed by all the professional bodies, to move the whole profession forward.
In overall terms, what are you trying to achieve?
What we are trying to achieve is a re-engineering of pharmacy's position in primary care and a greater stake in the health care process.