Primary Care Pharmacy June 2000 Vol 1 No 3 p70-72

Disease management

Primary care group anticoagulant clinics

By Andrew S. Radley MPhil, MRPharmS, Noel Dixon Dip Clin Pharm, MRPharmS and John Hall MSc, FRPharmS

This article looks at the role that community pharmacists can play in anticoagulant clinics

Warfarin is the most frequently prescribed anticoagulant in the UK and US and is used therapeutically in the prevention and treatment of thromboembolic disease. It has become the drug of choice through its reliable clinical effects, an onset of action determined by inhibition of clotting factor synthesis and a long period of activity. To be safe and effective, warfarin treatment requires regular monitoring of the International Normalised Ratio (INR).

About 1 million patients in the UK are currently taking oral anticoagulants. The growth in testing has been at least 100 per cent in the past five years. The increased demand for anticoagulant monitoring has placed a considerable burden on hospital outpatient clinics and the capacity for hospitals to cope with this increase has been limited. Consequently, the treatment of patients who could benefit from oral anticoagulation, such as those with atrial fibrillation, may have been compromised.
Various solutions to this problem are being proposed and tested:

• Satellite clinics from hospitals
• Community pharmacist-run clinics
• General practice surgery clinics run by a general practitioner (GP) or practice nurse
• Patient self-testing

Pharmacists are well placed to take on the role of practitioner in this field of managed care. Their knowledge of drug interactions, pharmaceutical products, pharmacokinetic principles and drug counselling skills make them particularly suited to the management of patients within treatment protocols.
The provision of anticoagulant care can be a professionally satisfying task, since it is an opportunity to help patients obtain the most benefit from their treatment. In addition, it allows the practitioner to implement changes to therapy decisions directly. Anticoagulant care is a practical skill that requires the application of theoretical knowledge, communication and patient assessment, and the ability to solve problems.

The beginning

When we sat around a table in 1991 to discuss the feasibility of community pharmacists organising oral anticoagulant monitoring services, we only half expected to be successful. We had experience from our involvement in hospital pharmacist-run clinics,¹ and we had the vision to improve the lot of the long-suffering anticoagulant patient who would spend hours travelling on ambulances and waiting around in outpatient departments.² However, there were those from our own and other professions who maintained that primary care clinics were not an option.
Nine years on, we now run three anticoagulant clinics a week in three different settings. One has been running as an outreach of the hospital clinic for five years, one is operating in a GP surgery and the third is organised in the clinical room of our community pharmacy for two GP practices. It is hoped that this last clinic will be extended to take patients from other practices within the newly formed primary care group.
We have developed an accredited distance learning package, have run training days for pharmacists and nurses in primary care and have produced a resource pack for the National Pharmaceutical Association based on our experience.
Our involvement in anticoagulant clinics began when two of us (ASR and JH) were employed as pharmacy teacher-practitioners by Sunderland health authority and Sunderland university. We took over the care of outpatients receiving anticoagulant therapy from two consultant physicians and their junior doctors. We developed standard operating procedures and established the monitoring system in line with national standards contained in the British Society for Haematology's "Guidelines on oral anticoagulation".³ An audit of the pharmacist-run clinics showed that care, in terms of INR results, was at least as good as the previous administration and patients "out of range" were generally returned more quickly to "in range" status by pharmacists than by junior doctors.⁴
The outpatient clinics continue to this day but we have moved on. JH joined ND in community pharmacy practice in Stanley, Co Durham and AR moved to the post of trust principal pharmacist at Perth Royal infirmary, Tayside in Scotland.

Primary care-based clinics

Anyone who runs large, centralised monitoring clinics cannot fail to realise that a great deal of inconvenience is borne by the patient. Clinics tend to be congested, significant finance is required both from the patient and the NHS for transport, and patients' lives are disrupted by time spent waiting in outpatient departments.
When JH took employment in community pharmacy, it was with a research and development brief. An application to the Royal Pharmaceutical Society in 1991 (the Sir Hugh Linstead fellowship) was successful in securing funding to test the idea of community pharmacists running anticoagulant clinics in a primary care setting.
A Department of Health grant led to the establishment of the outreach clinic. The experience we gained in running this service helped us to develop an in-house community pharmacy model in our premises.

Pharmacy-based model

We approached a number of surgeries in Stanley, Co Durham, and two fundholding practices, who valued the convenience of local services, decided to offer our facility to their patients. We were able to provide these practices with standard operating procedures, evidence of competence, quality control and quality assurance data and examples of documentation. This gave them the confidence to recommend our service to their patients. Thus, we now have experience of three primary care models : Outreach clinic from hospital GP surgery clinic for practice patients Community pharmacy-based clinic for a group of GP practices

Community pharmacy-based clinics are desirable

Whatever the set-up of the clinic, it is important that the recommendations of the British Society for Haematology are followed. This includes accredited training, co-ordination by or links with a lead physician, arrangements for quality control and assurance, links with the local pathology department and commitment to audit.
We feel that the community pharmacy clinic is a credible option and offers advantages over larger outreach and smaller GP practice models. Depending on caseload, an outreach clinic could be too large and would not necessarily have the local contact, with the result that it would end up as a smaller version of the centralised service it replaced.
If the clinic offers a rapid response by using near-patient testing equipment, the individual surgery model results in significant duplication of resources in terms of manpower, instrumentation, software and maintenance. It may not be of sufficient size to be cost-effective, and may not offer sufficient caseload to develop and maintain expertise in the operator.
By basing a clinic in a community pharmacy to serve the patients of that community, the clinic has to be:

• close to the primary health care team
• close to the patient
• able to operate domiciliary visiting
• a local expert resource to the prescriber
• able to offer rapid response
• locally accountable

We have shown that provision of the local clinic is feasible - even desirable. The challenge for community and primary care pharmacists is to develop an organised service to whole PCGs and health authorities.

How can others get started?

Training Pharmacists already have a good grounding in some of the aspects of anticoagulant care. They have undergraduate education in the processes of coagulation, in drug interactions, pharmacokinetic principles of warfarin and in the effect of diseases on anticoagulants. Community pharmacists have a wide product knowledge and experience in patient counselling.
Specific training that will be needed before setting up a clinic might include areas such as:

• knowledge updating
• the use of a coagulometer
• organisation of protocols
• clinic management
• the use of computer software

However, none of these will be entirely new to community pharmacists.

Initial experience of managing anticoagulant clinics should be gained by sitting in on an existing hospital or primary care clinic, if possible. Accredited learning should be undertaken and some form of certification should be developed to satisfy the requirements of clinical governance.

Quality issues The safety of any near-patient testing service depends on effective quality control/assurance (QC/QA) and it is clear that, as the service grows, there needs to be centralised local supervision of these procedures. A recent report from the Joint Working Group on Quality Assurance, "Guidelines for near patient testing" has confirmed this need. In some areas, pathology laboratories have provided QA/QC services for primary care diabetes clinics and would be a natural choice for community anticoagulant testing. If community pharmacists wish to offer their own service, it is important that they develop links with the local pathology laboratory.

Patient self management

In Germany, 40,000 people taking anticoagulants self-test at home. Patients are supported through accredited training centres. The manufacturers of monitoring equipment would like to see the market develop in the same way in Britain and want their testing strips to be included in the Drug Tariff. Ideally, training centres would need to be in a position to support the patient and implement a structured QA/QC service. A properly equipped local pharmacy would be a sensible referral point for the provision of this type of service in the community.

Conclusion

Expansion in the caseload of anticoagulated patients in hospitals is creating pressure and, consequently, devolution of the service is beginning to happen in many health authorities. Who manages the clinics in primary care will largely depend on who is best organised to provide that service. The same will apply when patient self management becomes more common. Pharmacy has often taken a lead in the hospital service, it is now time for us to support and extend that role in primary care.

Mr Radley is director of pharmacy at Perth Royal infirmary and Mr Dixon and Mr Hall are community pharmacists at Dixon and Spearman Ltd, Stanley

References