“There is no concern about the management of anticoagulant therapies. The patients are followed both in the area by family doctors and specialists, who together give answers to the patients and ask the institutions to help them in promoting greater collaboration between them”. Walter Marrocco, family doctor of the Federation of general practitioners (Fimmg) medicine expert regarding controversies linked to note 101 of the Italian Medicines Agencywhose suspension has just been extended for 4 months, which introduces new criteria for the management of anticoagulants in cases of venous thromboembolism and whose revision was recently requested by scientific societies in the sector, concerned about the complexity of managing the therapy.
In this context, the new suspension of the note “is certainly a positive fact, but only if we are able to use this period to review the criteria together (general medicine and specialists) and simplify access to these medicines. But with the right preparation”, he adds Morocco.
Note 101 at the moment it does not apply but “it would be desirable to archive it”, underlines the doctor, or, as specialists have already asked through scientific societies, “must be profoundly revised so that it can have real usefulness and be applicable. It is currently cumbersome”, says the doctor. The interest in the correct use of these drugs, continues Marrocco, is very high because “we are talking about very important pathologies, potentially dangerous for health and even for life: deep vein thrombosis, embolism pulmonary disease which can lead to disabilities or even deaths”. For these pathologies “before talking about drugs, we are talking about very complex diagnostic processes, which do not even have univocal guidelines at an international level”.
Currently with the suspension of note 101, as family doctors, “we continue to treat patients according to the previous criteria, indicated by an AIFA note, number 97, which allows the use of drugs for the treatment of non-valvular atrial fibrillation, leaving the other areas to the specialist. We therefore already have a regulation for some cases. Note 101 deals with the much more complex management, even by the family doctor, of deep vein thrombosis and pulmonary embolism. General medicine can also take charge of this process but first correct training, information and sharing is needed”. Simplifying access to medicines for the patient “is a very laudable principle that should be followed, but we must create that mechanism that guarantees the patient maximum treatment effectiveness“.
We know, he adds, that “venous thromboembolism is a very complex clinical and management problem, probably therefore just a note is not enough to regulate a path that not even international guidelines agree on. We need sharing of the path from a cultural and organizational point of view between the different actors. This means ensuring that there is homogeneity regarding therapeutic diagnostic skills among the various protagonists – anti-thrombosis centers, hospital facilities, sector specialists, general practitioners – to ensure that diagnosis and therapy are carried out in the best possible way” .
In this framework “it is necessary that the possible revision of note 101 makes the indications for diagnosis and therapy of the guidelines applicable. And to do this it is not enough to declare it but it is necessary to create the appropriate tools. The note cannot be an edict that does not take into account the organizational problems of the system“, concludes Marrocco.
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