• Farm Hosp · Jan 2013

    Review

    [Direct reporting by patients of adverse drug reactions in Spain].

    • M Esther Salgueiro, Francisco J Jimeno, Carmelo Aguirre, Montserrat García, Lucía Ordóñez, and Gloria Manso.
    • Farm Hosp. 2013 Jan 1; 37 (1): 65-71.

    AbstractThe Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance.Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

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