Haematologica 2003 - Supplements - Haematologica

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Self-testing and self-monitoring of oral anticoagulant therapypicking a finger. The prothrombin time is expressed.Commercially available instruments use differenttechnology to measure the clotting; the validity ofthese methodologies has been confirmed in the literature,which highlighted excellent correlationcoefficients of the capillary and reference methods(r=0.96) and a good analytical precision (CV=2.9-4.9%). These results are substantially the same forthe various types of instruments.In clinical practice, the development of portableinstruments led to the appearance of point of caretesting, transferring the analytical phase from thelaboratory to the patient, with advantages in termsof convenience and practicality for the patient; thewidespread use of portable instruments in someNorthern European countries confirms this. As amatter of fact, portable coagulometers, which wereinitially developed to be used in health care settingsby specialized personnel, are becoming commonlyused for oral anticoagulation therapy selftestingand in some cases or countries, for selfmanagement.3.1 Training on portable coagulometer useManagement safety of self-testing, and of selfmanagementin particular, strictly depends on anumber of critical steps. The patient must be capableof managing the instrument, of understandingits functioning and of using it properly.The main purpose of training courses on portablecoagulometers is to ensure correct use of theinstrument and, for self-management coursesproper OAT management. It is however necessaryto remember that OAT monitoring is actually thesimplification of a more complex activity.Patient Monitoring. Several studies demonstratedthat complications increase when the patient isnot adequately informed on potential complicationsand when the checks are performed withoutsuitable clinical evaluation. Proper training of thepatient and knowledge about the system and thematerials being used are therefore essential forcorrect use of the portable coagulometers. Thepatient must be supplied clear instruction manualsthat, besides supplying the technical informationon the instrument, include all the indicationson how to carry out fingerstick puncture accuratelyand the list of all possible interferences. Theuser/patient must be taught how to use the analyticalquality controls and how to behave whenresults are not acceptable.Training courses are an important step in ensuringproper use of the instrument and therefore inensuring greater OAT safety. However, to ensuregood functioning of the system (instrumental andanalytical control) and correct use by the patients(training courses and periodic re-evaluations), thewidespread use of these systems should be subjectto legislation and organizational regulation.Potential users of portable coagulometers are:a) patients and/or their relativesb) health care personnel (physicians, nurses) bothhospital-based and community-based.The main objective of the training courses are toprovide general information on OAT and the correctuse of the portable coagulometer to determine prothrombintime (PT/INR). General training on anticoagulationtherapy is of paramount importance toenhance more careful therapy management (AnsellJ 2000).Before giving an instrument to a patient or to anoperator the following issues must be evaluated:1. Physical handling skills of the operator.2. Proper understanding of the way the test is tobe carried out.3. Verification of the actual capacity of obtainingcorrect results.A fundamental pre-requisite to the organizationof training courses is the understanding that simplypurchasing a portable coagulometer, although producedaccording to basic requirements and in compliancewith European (CE) regulations, is notenough to guarantee the quality of the laboratorytest (PT/INR) and the safety of the patient/user.3.2 General organization of the coursesThe proposed organizational model is based onindications and experience already validated insome European countries (Bernardo A 1996, SawickiPT 1999), in which courses have been organizedfor several years for both self-determination of theprothrombin time (self-testing) and OAT self-management.We tried to determine a way of ensuringa correct use of these instruments, referring also toour direct experience (Cosmi B 1999, Cosmi B 2000).The users/patients who wish to participate in thecourses should sign a request form that lists thedetails of the program. Different courses should beorganized for PT self-testing and OAT self-management.Each course should have a maximum of 6patients. It would be appropriate to set a nationalyearly calendar of the courses and to prepare educationalmaterial both on general oral anticoagulationtherapy and specifically on the proper use of theportable coagulometer.At the end of the course the patient should havea general understanding of blood coagulation andanticoagulation therapy and should be able todetermine his or her PT-INR properly. Furthermore,the knowledge of the difficulties in obtaining theblood sample with a fingerstick is very important,because it is often lack of knowledge about thisissue that causes unreliability of results (Biasiolo A.2000).3.3 Selection of the patientsThe selection of the patient (or of a relative) is offundamental importance for therapy management.Haematologica/journal of hematology vol. 88(supplement 3):February 2003 5
Italian Federation of Anticoagulation ClinicsPortable systems are recommended especially forthe patients on long-term anticoagulation therapy.It is also thought to be safer to use portable coagulometersafter the anticoagulation levels havebecome stable for at least 3 months within the therapeuticrange, as this period is critical for possiblecomplications. The physician in charge of the patient(FCSA Anticoagulation Clinic, general practitionerthat has followed specific OAT training courses) canevaluate the clinical indications and patient’s compliance.Poor compliance causes greater therapeuticinstability (van der Meer FJ 1997) and this couldbe worsened by improper use of portable coagulometers.In general, portable systems are recommended for:- patients on stabilized oral anticoagulation therapy;- patients who are to remain on OAT indefinitelyor for the rest of their lives;- reliable patients (or reliable relatives);- patients restricted to their house or those wholive in poorly accessible areas;- patients with problematic venous access;- patients with jobs that cause frequent or longabsences.Criteria for exclusion are a patient’s unreliabilityor scarce compliance and previous thromboembolicand hemorrhagic complications. In the caseof OAT self-management, the motivation to learnis fundamental for successfully completion of thetraining period. It is also been proposed that thepatient’s cognitive function is re-evaluated periodically,using standardized simple systems, such asthe Mini Mental Test.4. Legislation and refundability4.1 Regulations on the use of monitorsLaw #332 published in the Gazzetta Ufficiale datedSeptember 8 th , 2000 takes up the European UnionDirective, 98/79/CE, on in vitro medico-diagnosticappliances. An in vitro medico-diagnostic device isdefined as any device made of a reagent, a reactiveproduct, a calibrating system, control material, a kit,an instrument, a device or a system, which is usedby itself or in conjunction with something else,which its manufacturer designed for in vitro examinationof human samples, including blood anddonated tissues, with the single or main purpose ofproviding information on a physiological or pathologicalstate, on a congenital abnormality or informationthat allows determination of the safety andcompatibility with potential receiving subjects orthe monitoring of therapeutic measures.Monitors can be defined as in vitro medico-surgicalappliances, although they are not formallyincluded in the list of appliances.The monitors destination of use is the “use towhich the appliance is destined according to theinformation provided by the manufacturer on thelabel, instruction manual and in advertisements“.The fundamental requirements that the appliancesshould comply with are listed in AttachmentI of the below listed legislative decree:• “… their use (must) not compromise directly orindirectly the clinical condition or the safety ofthe patients …”• “… must provide the performance declared by theproducer, especially in terms of analytical sensitivityand specificity, accuracy, repeatability…”• “… appliances for self-diagnostic tests mustensure that the appliance can be easily used bya layperson during all steps (of the test)”• “minimize the risk of user’s errors in using theappliance and in interpreting the results”• “the instruction manual must include informationon the sample to be used and on the possiblespecial precautions to be taken to obtain sucha sample”• “the instruction manual must indicate if specialtraining is necessary”• “the instruction manual must indicate if theappliance is to be used together with otherappliances”• “the instruction manual must indicate the informationon the type and frequency of the necessarymaintenance and calibration operations”Instructions must be specific for the appliancesfor self-diagnostic tests and must include a clearstatement that the user must not take any decisionof clinical nature without consulting his/her physicianfirst. Furthermore, the instructions must indicatethat the patient can adjust the treatment onlyif he or she has been trained accordingly.The European Directive on regulating in-vitromedico-diagnostic appliances will become effectiveon December 7 th , 2003. Monitors should thereforecomply with the above basic law requirements,which are intended to ensure the INR qualityobtained by the lay operator.The above listed regulation could be properlyapplied in two phases: A) the first one, applied inother countries such as the U.S.A., evaluates thecompliance of the self-diagnostic test systems tothe use for which the system was manufactured;and B) the second one identifies the structures thatcan systematically comply with the procedures tocorrectly identify the systems, to train and provideinformation on their use and to monitor them.The compliance evaluation procedures (basicrequirements complying with the common technicalspecifications) can be carried out by the HealthMinistry or by institutions that have been (previously)authorized after filing a request. In general,6 Haematologica/journal of hematology vol. 88(supplement 3):February 2003
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Haematologica 2003 - Supplements - Haematologica

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