AI Article Synopsis
- The Spanish Pharmacovigilance System, led by the Spanish Agency for Medicines and Health Products, monitors medicinal products for human use by coordinating regional centers to report adverse drug reactions.
- Historically, only health professionals could report these reactions, but there's a growing recognition of the importance of involving patients in the reporting process.
- This shift is highlighted in new European pharmacovigilance legislation, emphasizing active patient participation in identifying potential drug-related issues.
Article Abstract
The 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.
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| http://dx.doi.org/10.7399/FH.2013.37.1.121 | DOI Listing |
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