This week, the The Spanish Agency for Medicines and Health Products (AEMPS) published the Annual Report of the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H) for the year 2023. The report includes the most relevant aspects of suspected adverse drug reaction cases.
Here are the main highlights:
Impact of Adverse Drug Reactions: The report begins with a stark statistic from the European Commission, noting that 197,000 deaths occur annually due to adverse reactions to medications, making it the fifth leading cause of patient deaths in hospitals. This also incurs a significant economic cost of 79 billion euros annually.
Purpose of Pharmacovigilance: The primary goal of pharmacovigilance highlighted in the report is to identify, quantify, evaluate, and prevent risks associated with the use of authorized medications to ensure that their benefits continue to outweigh the risks.
Notification System: The report emphasizes the importance of the notification process for suspected adverse reactions through the Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano (SEFV-H). This includes contributions from both healthcare professionals and citizens, with all Spanish cases ultimately recorded in the FEDRA database.
Role of AEMPS: The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) plays a crucial coordination role within SEFV-H. AEMPS works with a network of pharmacovigilance centers across autonomous communities to evaluate and register adverse effects, which are suspected to be related to medications.
Data Analysis and Risk Management: Analysis of the FEDRA database helps in identifying potential new risks or changes in the severity of existing risks associated with medications. The AEMPS, in collaboration with the European network of medicinal agencies and the Pharmacovigilance Risk Assessment Committee (PRAC), evaluates this information to update authorization conditions and medication information.
Transparency and Public Communication: The report asserts that AEMPS publishes the notifications of suspected adverse reactions, ensuring transparency and aiding in the informed decision-making processes for both health professionals and the public.
These points underline the critical roles of data collection, evaluation, and communication in maintaining and improving the safety of medications through effective pharmacovigilance practices in Spain.
Trust us to enhance your pharmacovigilance processes with our expertise! Asphalion provides strategic and operational pharmacovigilance support, ensuring compliance with national and international regulations. Our services include human and veterinary pharmacovigilance, post-marketing surveillance for medical devices, and digital solutions like AsphaSearch, AsphaAlerts and AsphaDigiMedia.
You can have a look at the whole document here: INFORME ANUAL SISTEMA ESPAÑOL DE FV MEDICAMENTOS USO HUMANO
Contact us at: [email protected]
