Considering the current epidemiological emergency from Covid-19, the Italian Medicines Agency AIFA has communicated some transitional provisions related to monitoring registers and therapeutic plans:
- Monitoring registers
In order to reduce the burden on doctors and pharmacists operating within the healthcare facilities that are facing particular difficulties due to the current emergency, the mandatory data entry relating to treatments with medicines subject to monitoring via the web-based AIFA registers can be postponed up to a maximum of 90 days from the date of the AIFA communication.
This measure applies only in the case of patients already undergoing treatment and, therefore, already registered in the AIFA platform. The start of new treatments and the registers of innovative drugs are excluded from this measure.
At the end of the extension period the usual operating procedures will be automatically re-established.
Finally, it should be noted that the above provisions do not exempt from compliance with the monitoring and evaluation measures provided for in the register.
- Therapeutic plans
In order to reduce the risk of SARS-CoV-2 infection in elderly patients and/or with chronic diseases, limiting the turnout in specialist clinics for the renewal of therapeutic plans, the validity of web-based or paper-based therapeutic plans already signed by specialist doctors and due to expire in the months of March and April will be extended by 90 days starting from the expiry date. At the end of the aforementioned extension period the renewal of the therapeutic plans must take place in the usual way.
If the patient gets worse because of the underlying disease or an intolerance to the treatment, the extension of validity cannot be automatic, but the reference specialist must be contacted.
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