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On the role of the Pharmacist in Near Patient
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Testing with In Vitro Diagnostics
On the role of the Pharmacist in Near Patient Testing with In Vitro Diagnostics
Tests available for Near Patient Testing
Single test technologies
Practical issues
Analysis and Equipment
Health and Safety
Required Skills
Quality Assurance
Recording of results in the patient record
Tests available for Near Patient Testing
This listing is limited to tests which can be carried out in a few minutes, without recourse to the use of complex instrumentation. The design of the products is centred around ease of use, which often means that the result must be manually recorded. Some are produced in a format also appropriate for home use, which requires that they are particularly robust and documented in terms easily understood by the layman. It may be the case that the trained staff of a pharmacy can provide support to patients electing to select these products for use in their own homes, as well as providing the testing service within the pharmacy itself.
Concerning products which utilise more complex instrumentation in this area, the Medical Devices Agency intends to prepare a Device Bulletin on the purchase, management and use of near patient testing equipment. This proposal has a broad degree of support from their In-Vitro Diagnostics Advisory Committee (IVDAC), laboratory professionals, providers of external quality assurance schemes, the National Quality Assurance Advisory Panel for Clinical Chemistry, and the Department of Health. The Bulletin will not consider the issue of whether or not to utilise NPT equipment, but to provide practical advice to those using or considering the use of these devices. A date for publication has yet to be announced.
Blood glucose (requires blood sample)
With an estimated one million undiagnosed type 2 diabetics in the UK, and clear evidence that early diagnosis and treatment significantly reduces the severe sequelae of the condition, screening at risk groups pays huge dividends. Several different manufacturers supply blood glucose meters, mainly used by type I diabetics to manage their condition. These meters are ideal for in-pharmacy use, some include automatic download of results via automatic communication to a host computer through the internet.
Glycated Haemoglobin (requires blood sample)
Whereas a blood glucose test indicates the level of glucose at the moment the sample is taken, Glycated Haemoglobin indicates the long term stability of blood glucose levels, and is used to monitor the long term effectiveness of diabetic treatment. Standardisation of results by different methods has recently been agreed, in the light of which its use ‘near the patient’ is likely to increase. There is an argument that Glycated Haemoglobin has a role in diagnosis of diabetes because its longer term indication of glucose levels is superior to a single blood glucose test. Several manufacturers provide products.
Microalbuminuria (requires urine sample)
A simple urine test, some products using a small electronic reader for the ‘dip-stick’, indicates the level of albuminuria, important in the diagnosis and management of hypertension and diabetes.
Helicobacter Pylori (requires blood sample)
The causative organism of most duodenal and gastric ulcers, and implicated in many cases of chronic dyspepsia, a simple blood test can determine the presence of antibodies. Treatment is simple and effective. It should be noted that should one wish to test for eradication after treatment, a test for the antigen itself is recommended. This can be managed in primary care, but currently requires that a breath sample is sent to the laboratory. New technologies are under trial for this also to become available as a rapid test. Several manufacturers provide products.
Pregnancy tests (requires urine sample)
In addition to the self-use pregnancy tests available to the public OTC, versions for professional use are widely available packaged in multiple lots. Some have internal quality assurance features. Small ‘dip-stick’ products are also available with electronic readers.
Haemostasis (requires blood sample)
Coagulation testing in Primary Care, or by the patients themselves, offers great benefits in terms of reduced visits to the hospital, and in the patients understanding and managing their condition. The early recognition of thrombotic disease and the prolonged use of anticoagulants to improve patient outcomes is resulting in an increase in the need for efficient testing regimes. Various products are available, including self-testing designs.
Cholesterol, lipids and other risk factors for Coronary Heart Disease (requires blood sample)
The understanding of the risk factors contributing to CHD is increasing rapidly, with a number of tests available to the physician, of which Cholesterol is only one. There are many products suitable for Pharmacy use to support Primary Care in the management of this major cause of ill health in the UK, some including software packages to calculate risk of a cardiac event, on entering lifestyle, physical and blood test data.
Urinary Tract Infection (requires urine sample)
Simple urinary tests detect most urinary infections, which if untreated can lead to more dangerous conditions . Generally packaged as a self-test, a testing service would be simple to provide. Some products test for nitrites only, others test for leukocytes in addition.
Strep A (requires the use of a throat-swab)
Tests are available for determination of the presence of Strep A in cases of sore throats prior to the decision to treat with antibiotics. The major benefit is to exclude the organism in order to avoid the inappropriate use of drugs.
Glandular Fever (requires a blood sample)
The diagnosis of Glandular Fever often follows after a prolonged period of the patient failing to respond to antibiotic therapy for chronic throat symptoms. A simple blood test is available to detect this condition which can have long term deleterious effects, particularly in the young, if not diagnosed in a timely fashion.
Urea and electrolytes (requires a blood sample)
One of the most common combination tests requested by General Practitioners of their local laboratory, this group of tests can now be provided near the patient without recourse to complex equipment. Hand-held instruments developed for instant use in acute intensive care can be easily used in a Primary Care role. The results are used as diagnostic indicators across a range of conditions.
C-reactive protein (requires a blood sample)
Useful in the management of patients with inflammatory diseases, CRP is considered superior to ESR (erythrocyte sedimentation rate), and can be available in minutes.
Practical issues
Analysis and Equipment
Choice of methods of analysis should take these factors into account:
The number of assays likely to be carried out in a day
Comparability with results from local laboratory
Availability of support from local laboratory
Health and Safety
Procedures involving patients and biological analyses require adherence to health and safety standards, for the safety of the patient and the operating staff
Hygienic methods of obtaining specimens without contamination
Seating or couch for patients who may feel faint during or after blood sampling
Staff training in basic first aid techniques
Formulation of safety procedures concerning ‘sharps’ disposal and decontamination of work surfaces
Advice taken on electrical and chemical hazards, including COSHH (Control of substances hazardous to health)
Issues of physical security, confidentiality and adherence to the Data Protection Act
Required Skills
Specimen collection by finger-prick or venepuncture, including patient preparation and aftercare in the case of an adverse reaction
Core competencies to satisfy the training requirements of the manufacturer of the products to be used in analysis
Core competencies to satisfy the requirements of quality assurance procedures, data handling and the use of the result in the management of the patient, whether this be direct or through a medical practitioner
Quality Assurance
Internal. This procedure is designed to validate the result prior to it being issued and acted upon. Some IVD products have quality assurance built in, and therefor performed automatically. Most techniques require operator intervention to perform quality assurance, using commercial control samples. Ideally, this checks the operator performance as well as that of the product
External. Carried out on samples supplied by EQA providers, the results are not available prior to the patient’s results being issued. The value of running external quality assurance is in the long term maintenance of quality, and validates the local procedures in respect to peer performance
Recording of results in the patient record
Continuity of record is essential to the success of the use of IVDs near the patient. Many thousands of tests are performed, even in hospitals, which never reach the patient record. The importance of a quality assured means by which the validated results of the analysis are recorded, and added to the patient record (notes) cannot be overstated
The use of electronic records will simplify the management of results in the long term. Emerging primary care networks offer a key resource in capturing and filing test results carried out near the patient
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