Aifa’s Note 101 Draws Criticism from Medical Experts
The recent establishment of note 101 by the Italian Medicines Agency (AIFA) has sparked criticism from eight medical-scientific societies. The note, designed to define the criteria for prescribing oral anticoagulant drugs for the NHS, has come under fire for its lack of transparency and its potential to trivialize an important and potentially fatal disease.
President of the Italian Society for the study of haemostasis and thrombosis (Siset), Valerio De Stefano, emphasized the complexity of the treatment of venous thromboembolism, calling for a revision of note 101 to put the role of specialists back at the center. He expressed concerns over the lack of transparency in the methodology of the guideline, noting the absence of expert panel information and conflicts of interest disclosure.
Roberto Pola, national secretary of the Italian Society of Angiology and Vascular Pathology (Siapav), echoed De Stefano’s sentiments, stressing the serious nature of venous thromboembolism and the need for specific skills to manage the pathology and its treatment. He raised concerns about the potential risks associated with anticoagulant therapy, noting the importance of expert involvement in decision-making processes.
With an estimated 3 million patients in Italy on anticoagulant therapy, the president of the Federation of centers for the diagnosis of thrombosis and surveillance of anticoagulant therapies (FCSA), Daniela Poli, highlighted the implications of note 101 for the nearly 600 thousand patients affected by venous thromboembolic episodes. She expressed the need for corrections to the note to prevent incorrect treatments based on errors and inaccuracies.
The criticisms extended to the document’s handling of age-related risk factors and the use of anticoagulant drugs during breastfeeding, with calls for specialist support to adequately treat patients and correct the noted inaccuracies.
In light of these concerns, the medical societies have called for a reflection on how to integrate discussion points between specialists and general practitioners. They emphasized the fundamental role of specialists at critical decision-making points in treating venous thromboembolism and urged AIFA to open a discussion table to address these issues.
Despite sending a letter to AIFA in December highlighting critical issues with note 101, the medical societies have received no response, prompting further calls for a revision of the guidelines.
The criticisms signal a pressing need for transparency, collaboration, and specialized expertise in the treatment of venous thromboembolism, highlighting the importance of revising note 101 to ensure the safety and efficacy of anticoagulant therapy for patients.