title: [Direct reporting by patients of adverse drug reactions in Spain].
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.
authors: M
authors: M
authors: Esther Salgueiro
authors: Francisco J
authors: FJ
authors: Jimeno
authors: Carmelo
authors: C
authors: Aguirre
authors: Montserrat
authors: M
authors: García
authors: Lucía
authors: L
authors: Ordóñez
authors: Gloria
authors: G
authors: Manso
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005060:Europe; D006077:Government Agencies / Q000191:economics / Q000331:legislation & jurisprudence / Q000458:organization & administration; D006801:Humans; D020407:Internet; D010358:Patient Participation / Q000331:legislation & jurisprudence; D060735:Pharmacovigilance; D011177:Postal Service; D056737:Safety-Based Drug Withdrawals / Q000331:legislation & jurisprudence; D057566:Self Report; D013030:Spain / Q000453:epidemiology; D013689:Telephone; D014944:World Health Organization