The Spanish Agency for Medicines and Health Products (AEMPS) has published the User Manual for NotificaRAM, a key tool of the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H) whose objective is to promote the notification of suspected adverse reactions medications to ensure continuous monitoring of their safety.
In addition to containing the general aspects of NotificaRAM, the manual explains how this form should be used with images of each step that contribute to improving the user experience and whose objective is to the notification is as complete and detailed as possible.
In the case of healthcare professionals, it details how they can register in the system. making it easier to send new notifications where the notifier’s data will appear automatically populated each time you log in with your email and password.
Up to 35% of cases are reported through this system
The AEMPS made this electronic form available to health professionals and citizens in 2013, as a more accessible and more effective alternative to the yellow card in paper format, used since the end of the 1980s. Its implementation was a decisive step for facilitate and promote notification.
Since its launch in 2013, nearly 35% of files declared directly to the SEFV-H have been done via this electronic form. These cases allow the SEFV-H to begin the study of new pharmacovigilance signalscontributing to the identification of new adverse effects.
Currently, NotificaRAM is available in co-official languages and has help texts. This tool is constantly improved, adapting to new needs that may arise, such as the adaptation for the reporting of adverse events occurring after vaccination against COVID-19.
The contribution and effort of health professionals and citizens Reporting suspected adverse reactions is crucial. Your collaboration is essential to improving knowledge about medicines.
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