The Spanish Agency for Medicines and Health Products (AEMPS) has published the manual for the use of NotificaRAM, an important tool of the Spanish pharmacovigilance system for medicines for human use (SEFV-H), whose aim is to promote the reporting of suspected adverse reactions to medicines in order to ensure continuous monitoring of their safety.
In addition to covering general aspects of NotificaRAM, the manual explains how this form should be used, with images at each step that help improve the user experience and aim to make the notification as complete and detailed as possible.
In the case of health professionals, it describes in detail how they can register in the system to facilitate the sending of new reports, with the reporter’s details being automatically filled in each time they log in with their email address and password.
The AEMPS made this electronic form available to health professionals and citizens in 2013 as a more accessible and efficient alternative to the paper yellow card used since the late 1980s. Its implementation was a crucial step in facilitating and promoting notification.
Since its introduction in 2013, almost 35% of cases reported directly to the SEFV-H have been processed using this electronic form. These cases allow SEFV-H to begin investigating new pharmacovigilance signals and thus contribute to the identification of new adverse reactions.
Currently, NotificaRAM is available in the co-official languages and has help texts. This tool is constantly being improved and adapted to new needs, such as adaptation for notification of adverse events that occur after vaccination against COVID-19.
The contribution and efforts of health professionals and citizens in reporting suspected adverse reactions are crucial. Your cooperation is essential to improve knowledge about medicines.
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