Background
The NHS has adopted a rigorous, evidence-based approach to the introduction of new 'technologies' including new services. Randomised controlled trails are the preferred study design because, if conducted appropriately, they provide the best evidence that change is due to the intervention and not other confounding factors. In this case, a randomised controlled trail will evaluate the clinical and cost effectiveness of Medicines Management as "The process of optimising beneficial outcomes and minimising harm from medicines, including medication review (appropriateness), monitoring and advice to patients and prescribers".
Aims and Objectives
To evaluate Medicines Management by community pharmacists for patients with a confirmed diagnosis of coronary heart disease (CHD).
Primary objectives are to:
Compare the proportion of patients receiving appropriate treatment, as defined by available evidence and guidelines
Describe the change in patients' overall health status
Evaluate the cost-effectiveness of the intervention by considering changes in the use of resources including the costs of: medication, pharmacist's time, training costs and any changes in health service utilisation for CHD (e.g. GP visits). Time and travel costs to patients will also be examined
Secondary objectives are to describe:
The opinions of patients, GPs and their staff and community pharmacists
The barriers to implementation and recommendations for change
The role of over-the-counter (OTC) medicines in the overall patient management of this condition
Study Design
A randomised controlled trial (where the control group represents 'usual care' vs the Medicines Management intervention).
Patients Inclusion Criteria:
Male and female patients with a confirmed diagnosis of CHD (defined as previous myocardial infarction, angina, coronary artery by-pass graft (CABG), angioplasty) identified by their general practice
Exclusion criteria: illiterate, innumerate, suffer from alcohol or drug misuse, terminally or seriously ill, severe mental illness, unable to give informed consent, or in the opinion of their GP are unsuitable to participate in the study.
Letters were sent to all eligible patients describing the study and inviting them to participate. Patient information sheets and consent forms were included. 1389 patients were recruited (901 intervention, 488 control) in total from the nine project areas.
Intervention
Patients were asked to visit their chosen pharmacy and present a registration card to the pharmacist. Pharmacists received a core data set of information about patients in the intervention group (extracted from medical records by local audit staff). If necessary the pharmacist visited the practice to extract additional data from medical notes to supplement the core data set, data obtained from the pharmacy medical records and the patient.
The initial contact took the form of a patient interview by the pharmacist. This initial interview was planned to last approximately 20-30 minutes and subsequent interviews 5-10 minutes. The pharmacist on the basis of the individual patient's needs was asked to determine the number of subsequent interviews. In addition, there could be opportunistic input from the pharmacist at the point of dispensing when patients (or their representatives) presented prescriptions to be filled. The intervention is most likely to be delivered from the community pharmacy premises, although there could be occasions when the pharmacist needed to make a home visit. Control patients were advised that they would continue to receive their standard treatment. The project is now ongoing. The first patients for the main phase were seen by pharmacists for their initial visit in November 2002 and the last patient will complete their intervention period at the end of April 2004.
Evaluation
Clinical appropriateness will be evaluated using data abstracted from medical and pharmacy clinical records by researchers. To avoid bias, staff involved in data collection will not be told whether patients are allocated to the intervention or the control group. Opinions of patients and health care professionals will be assessed by questionnaires, completed at baseline and twelve months by patients and health care professionals will be assessed by questionnaires, completed at baseline and twelve months by patients and health care professionals. Focus groups and individual interviews will supplement these.
Pilot Areas
Nine areas in England were selected for the project:
Lichfield
Nantwich
North Southwark
North Tyneside
Poole
Portsmouth
Salford
Shipley & Baildon
Walsall
The areas were carefully selected from a large number of bids for pilot status and the factors taken into account when selecting these areas included; socio-economics, prevalence of CHD, support from PCG/PCT and previous experience in collaborative working.
Across the nine areas, the Project involves approximately 40 GP practices, 69 community pharmacies and 72 community pharmacists. Over 12000 CHD patients were invited to participate.
Local Co-ordinators
Attached to each of the pilot areas is a local research co-ordinator. The local co-ordinators ensure that both the research aspects and other project management aspects are delivered within each locality.
Training
There was a thorough training programme for all those involved in the project and this was organised and delivered by the Centre for Pharmacy Postgraduate Education. This has involved additional training for pharmacists on the clinical aspects of the treatment of coronary heart disease and communication and counselling skills.
Ethical Approval
The project was approved by the Scottish Committee Multi-Regional Ethics. Local Ethical Approval was then obtained for each area.
Information about the Project
This particular approach to medicines management means that over the past few years considerable effort has been put in by all of the national bodies in designing, in fine detail, a medicines management service which is now being evaluated through a large scale randomised control trial of the intervention.
The community pharmacy medicines management project (PSNC project) is specifically designed for the community pharmacy setting. The project builds on the accessibility and convenience of the community pharmacy together with the community pharmacist's in-depth knowledge of the patient. This means that the community pharmacist is in a unique position to deliver an effective intervention. The fact that having been designed, this intervention will be rigorously tried and tested and evaluated using robust research methodology should deliver compelling evidence of the added value of the community pharmacist's input. The economic evaluation of the results will determine the cost effectiveness of the intervention.
The Community Pharmacy Medicines Management Project
Marine Avenue Surgery
47A Marine Avenue
Whitley Bay
Tyne & Wear
NE26 1LZ
Tel/Fax: 0191 251 6064
helen.rhodes@psnc.org.uk
info@medicinesmanagement.org.uk
