In a letter Siset, Fcsa, Siapav, Simi, Fadoi, Yes is, Yes, Anmco underline that “the treatment of venous thromboembolism it is a very complex clinical and management problem, for this reason the note 101 recently established byItalian Medicines Agency (Aifa) to define the criteria prescription of oral anticoagulant drugs by the NHS must be revised”
“The treatment of venous thromboembolism is a very complex clinical and management problem, for this reason note 101 recently established byItalian Medicines Agency (Aifa) to define the criteria for prescription of drugs by the NHS oral anticoagulants it must be revised in content and method, so that it puts the role of specialists back at the center”. Valerio De Stefano, president of the Italian Society for the study of haemostasis and thrombosis (Siset) commenting on the note 101 of Aifa published in the Official Journal in recent weeks, against which as many as eight medical-scientific societies (Siset, Fcsa, Siapav, Simi, Fadoi, Yes is, Yes, Anmco) have mobilized to ask for it to be revised.
“As regards the method – explains De Stefano – note 101 indicates clinical scenarios and suggests some behaviours, including the extension of the treatment. Now the methodology of a guideline provides for much more transparent work than what was done with note 101, indicating the panel of experts participating in the drafting, any conflicts of interest and the working methodology. None of this appears from the publication of the note and to our knowledge there has been no contact and no consultation with the scientific societies that I represent at this moment in addition to the Siset, or the Federation of centers for the diagnosis of thrombosis and surveillance of anticoagulant therapiesthe Italian Society of Angiology and Vascular Pathologythe Italian Society of Internal Medicinethe Federation of associations of internal hospital managers. there Italian Society of Hematologythe Italian Society of Cardiology el'National Association of Hospital Cardiologists”.
The “second point we question – underlines De Stefano – is the contents. Venous thromboembolism is a very controversial topic and requires particular experience to establish the indication and duration of treatment. In fact, it should be considered that the use of antithrombotic drugs inevitably entails a haemorrhagic risk in the short and long term. Note 101 provides a series of tools stratifying patients at low, medium and high risk of thrombotic progression and patients at low, medium and high risk of haemorrhagic complications. But it must be said that these predictive tools are notoriously not particularly effective in this context and there are situations in which the treatment must be extremely personalizedalso involving patients in the decision-making processes of risk/benefit assessment”.
“The Venous thromboembolism is the third leading cause of cardiovascular death, after myocardial infarction and ischemic stroke.. Venous thromboembolism means deep vein thrombosis and also pulmonary embolism, therefore a complex of serious, potentially fatal pathologies which, among other things, require anticoagulant treatment which, beyond its benefits, also has potential risks, especially haemorrhagic” observes Roberto Pola, national secretary of the Italian Society of Angiology and Vascular Pathology (Siapav), who adds: “However, with Aifa's note 101 there is a risk of trivializing an important and potentially fatal disease”. This is because, underlines the expert, “treating venous thromboembolism requires specific skills as the pathology is serious in itself and requires complex and difficult to manage therapy”.
“It is estimated that in Italy there are approximately 3 million patients on anticoagulant therapyof which 2.4 million treated with new drugs and 700 thousand with anti-vitamin K anticoagulant drugs”, explains Daniela Poli, president of the Federation of centers for the diagnosis of thrombosis and surveillance of anticoagulant therapies (FCSA) which specifies: “Approximately 22-23% of the entire population – that is, almost 600 thousand patients – are on anticoagulant therapy because they have had a venous thromboembolic episode. These are the patients affected by AIFA note 101 which must be reviewed.”
“Before note 101 – continues the expert – AIFA had already adopted, with note 97, a similar decision for patients with atrial fibrillation, authorizing prescription for all categories of doctors, without limitations. But atrial fibrillation represents a condition in which, once the indication for treatment has been obtained, this is substantially maintained and preserved over time, barring significant complications. The sector governed by note 101, which concerns deep vein thrombosis and pulmonary embolism, is instead a very different field in which there are some certainties about treatments, especially in the initial phase of the pathology, and other more complex areas, such as the decision about the duration of therapya problem that is still open and unsolved.”
According to him, Poli also lists dangerous errors and inaccuracies contained in the document: “Inside the document we read, for example, that these anticoagulant drugs cannot be used during breastfeeding. Which is not correct – he points out – because some of these drugs, such as direct anticoagulants, cannot be used during breastfeeding while direct oral anticoagulants, anti-vitamin K, can be used”. Then there is “another inaccuracy that can have an effect on a very large portion of the population: of the 600,000 patients treated every year in Italy for venous thromboembolic episodes, 200,000 are over the age of 75. In note 101 it is written that having an advanced age constitutes a risk factor for relapse. But this is not true: the data we have available are not very many but the majority of these tell us that the risk of recurrence is high in the patient with venous thromboembolism in a manner completely independent of age”.
“So what let's ask – underlines Poli – it is substantially to correct errors and inaccuracies in the note which may lead to incorrect processing. And to underline that, with the exception of those conditions in which the envisaged treatment scheme is absolutely shared and can therefore be adopted by any doctor, for the pathologies covered by AIFA note 101, specialist support is necessary to properly treat the patient, in particular regarding the duration of therapy”.
Roberto Pola then reserves a specific reflection on the essential role of angiologists for the management of this pathology: “It is the specialists who first make the diagnosis of deep vein thrombosis, in the vast majority of cases by performing a color Doppler ultrasound which is already in itself a specialized methodology that requires certain skills. They are also the doctors who carry out the diagnostic and ultrasound follow-up of deep vein thrombosis to verify that the thrombosis has resolved over time after the start of therapy”. They are specialists “able to measure any residual thrombosis which is also a parameter to take into consideration when deciding how long to continue a therapy, whether to suspend it or whether to modify the dose”, he adds.
In conclusion, the Siset president, De Stefanoasks “that there be a reflection on how to integrate some points of discussion between the specialist and general medicine. We believe that the role of the specialist at the moment of diagnosis, at the moment of deciding whether to prolong anticoagulant treatment, and at the moment of suspension of anticoagulant treatment is fundamental. These decision-making points can and must (as already now) be managed in collaboration with general practitioners but never without assuming specialist responsibility, to protect above all patients but also general practitioner colleagues, potentially exposed to difficult situations. management”. Therefore “we ask that a discussion table be opened on this and that we return to sharing objectives and methods to achieve them. We sent a letter to Aifa on December 4th, in which we highlighted these critical issues. Since then we have had no response,” he concludes.
#Anticoagulant #drugs #concern #Aifa #note
