Haematologica 2003 - Supplements - Haematologica

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Self-testing and self-monitoring of oral anticoagulant therapythe compliance evaluation does not take intoaccount clinical data. The PT-INR measured byportable coagulometers does not require the efficiencyconditions and standards normally used inevaluating the results of a clinical laboratory.In order to obtain a positive compliance evaluation,it could be sufficient for the manufacturer toproduce documentation of the type listed below:• 150 patients enlisted in 6 centers for a 10 weekstudy period;• patients’ selection based on pre-defined criteria;• systematic instrument training period (run inphase);• home delivery of the instrument, measurementand filing of PT-INR every week for 10 weeks;• every two weeks the patient returns to the clinicor to his/her general practitioner and carriesout the test with the instrument in front of thehealthcare worker. The same health care figurethen carries out the test on the patient withthe same instrument and then draws venousblood to be tested in a certified laboratory todetermine PT-INR;• the agreement among the various measurementsis then evaluated.The Health Ministry or an authorized institutioncertifies the compliance of the instrument to theuse for which it was built. The portable coagulometercan then become commercially available,but its use by the patient or by non-medical personnelrequires the activation of phase B), in whichspecifically selected health-care workers prescribesa therapy plan.4.3 Therapy planAs previously highlighted, the use of portablecoagulometers by the patient requires: a) a criticalevaluation of the patient’s capability of carryingout the test; b) proper training on the correct wayto use the instrument (and possibly training onself-prescription); c) the positive reliability of theresult obtained with a specific instrument; d) monitoringthe quality of results over time; e) monitoringthe patient’s physical and mental ability toobtain a correct result over time (and possiblymonitoring his/her capability for self-prescription);f) the clinical re-evaluation of the patient. Theresponsibility for these procedures can be assignedto a specific clinic or, at least partially, to a generalpractitioner properly trained to monitor oralanticoagulation therapy.The Anticoagulation Clinics constitute a networkthat covers the whole nation and are experiencedin anticoagulation therapy and in training patients.The clinics are therefore the ideal centers to prescribethe therapy plan and to check the instruments’quality periodically. The therapy plan couldpossibly include the request to the National HealthSystem to refund the cost of the instrument andthe diagnostic strips. As a matter of fact, in someclinical situations portable coagulometers appearto be necessary (difficult venous access, logisticalimpossibility of reaching laboratories or clinics),appropriate (patients who cannot walk and whoare forced to stay at home) or recommended interms of cost/benefit ratio (long term anticoagulationtherapy, working age patients). This last aspectis not to be underestimated: the initial cost of thecoagulometer (about 1,000 Euro, although thecoagulometer can be re-used by several otherpatients) is counter-balanced by the reduction ofother costs (loss of working hours for the patientand for relatives who have to accompany thepatient, transportation costs) and by the reductionof work load for the clinic. The cost of the reactivestrips and of the finger sticks (about 5 Euro) doesnot differ much from the cost of drawing venousblood in a clinic laboratory.The following scenario can therefore be sketched:the portable coagulometer that has passed thecompliance check by the Health Ministry can bepurchased by the patient or can be assigned tohim/her by the National Health System after arenewable therapy plan has been submitted. Thetherapy plan can be compiled by the physicians ofapproved structures (FCSA centers) or by generalpractitioners who have followed the specific coursesjointly organized by the FCSA and the ItalianSociety of General Practitioners. The general practitionerswho have compiled a therapy plan should,in any case, delegate the periodic checks of theinstrument to a clinic, while awaiting a simplificationof this procedure (see chapter 2).4.4 Refundability of portablecoagulometers in other European countries• Holland: mostly private (88%) health system,supported by religious or volunteer non-profitorganizations. University hospitals are state run.Health insurance schemes are both private andpublic. Full refundability of the coagulometer, ofthe reactive strips, of the self-testing trainingcourse from April 2002. Anticoagulation clinicsselect self-monitoring patients (Dutch GovernmentGazette, 4 December 2001, N. 235, page 13).• Germany: Public and private health insuranceschemes. Full refundability of the coagulometer, ofthe reactive strips and of the training course.• Denmark: Public health insurance. Full refundabilityof the coagulometer, of the reactive stripsand of the training course since October 1999.• Austria: Public health insurance. Full refundabilityof the coagulometer and of the reactivestrips by several public insurance schemes (it variesfrom region to region).Haematologica/journal of hematology vol. 88(supplement 3):February 2003 7
Italian Federation of Anticoagulation Clinics• United Kingdom: Public health insurance.Refundability of the reactive strips only since May2002.• Spain: The health system is decentralized andregionally managed. Currently no refunds are available.RecommendationsThe effectiveness of OAT and safety criticallydepend on the quality of therapy monitoring. Themanagement of patients is recommended to be acontinuous and systematic process that must includethe review of laboratory tests and organized education,communication and follow-up system for thepatients (recommendation level 1C) (see Appendix1). Today, the management model that best meetsthese requirements is OAT Clinics.OAT self-monitoring using portable coagulometers,both as self-testing and self-management, is anew therapy management model that has thepotential advantage of being more convenient andof possibly improving the follow-up check quality, atleast for some patients (recommendation level 2B)(see Appendix 1).Strictly necessary self-monitoring requirementsare: a) accurate selection and training of thepatients; b) periodic checks of the measuring instrumentby an independent institution; c) maintenanceof an organized system for continuous training,communication and patients’ follow-up. In any case,in order to satisfy these requirements it is recommendedthat the patients’ self-management is followedand supervised by an Anticoagulation Clinicor by the patients’ general practitioner.In conclusion, based on current scientific knowledge,in order to ensure the safety of the patientsand the effectiveness of oral anticoagulation therapy,it is necessary to regulate the use of portablecoagulometers in our country.In particular, self-management appears to requirethe structuring of a monitoring system capable ofchecking the quality of OAT management over timeand of systematically detecting complications, sothat the cost-benefit ratio can be properly evaluated.It is necessary to establish a connection betweenthe organization that implements the training programand the patient, who is to be properly followedalthough s/he has a greater autonomy.A network of Anticoagulation Clinics (n=296)grouped in a Federation (FCSA) covers the wholeItalian territory. These centers participate in trainingcourses organized by the Federation. They cantrain patients and participate in compulsory checkof therapy and laboratory quality. Using a therapyplan like the one outlined above, the clinics canidentify patients who are suitable for using theportable coagulometers at home, they can organizetraining courses and they can distribute coagulometers,reactive strips, finger sticksThe dosage of anticoagulation can be adjusted bythe clinic, by the general practitioner specificallytrained for this purpose or by the patient himself/herselfafter a specific self-prescription course.The cost of all the above activities must be planned;it is therefore necessary to determine the maximumyearly number of patients who can benefit fromportable coagulometers provided by the NationalHealth System.The same procedure can be applied to districtpoints of district health care.The clinics are responsible for the quality checksof the instruments.8 Haematologica/journal of hematology vol. 88(supplement 3):February 2003
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Haematologica 2003 - Supplements - Haematologica

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