Abstract

MENDES, Diogo; ALVES, Carlos  and  MARQUES, Francisco Batel. Severe iatrogenic adverse drug reaction reports: results of the activity of the Regional Pharmacovigilance Unit of Central Portugal. Rev Port Med Geral Fam [online]. 2012, vol.28, n.1, pp.34-40. ISSN 2182-5173.

Objectives: This study aims to characterize the adverse drug reactions (ADR) reported to the Regional Pharmacovigilance Unit of Central Portugal (UFC), to document the contribution of reports of ADR by health professionals to pharmacovigilance in Portugal, and to identify the new knowledge produced by the activity of the UFC. Type of study: Cross-sectional. Setting: Regional Pharmacovigilance Unit of Central Portugal. Population: Spontaneous reports from the geographic area corresponding to the Health Administration of the Central Region of Portugal. Methods: Spontaneous reports (SR) of ADR received in the UFC between January 2001 and August 2011 were included. Causality was assessed using the global introspection method. Severity was assessed according to World Health Organization (WHO) criteria. Previous description of an ADR was assessed by consulting the Summary of Product Characteristics. Suspected drugs were classified in categories according to the Portuguese Drug and Therapeutics Bulletin. Suspected drugs were classified in categories according to the Bulletin. ADR were classified according to the MedDRA dictionary. Results: The UFC received 1846 SR of ADR between 2001 and August 2011. 999 met the inclusion criteria. We identified 149 (14.9%) unknown ADR and 428 (42.8%) serious ADR. 70 (7.0%) ADR were simultaneously unknown and serious and 41 (4.1%) simultaneously unknown, serious, and certain or probable. Physicians reported 577 (57.8%) ADR, of which 340 (34.0%) were reported by family physicians. Pharmacists reported 354 (35.4%) ADR and nurses 66 (6.6%). Conclusions: Unknown ADR (149; 14.9%), unknown and serious ADR (70; 7.0%) and unknown serious certain or probable ADR (41; 4.1%) received by the UFC show that SR are of great value in increasing knowledge about the safety profiles of drugs.

Keywords : Drug Surveillance; Postmarketing; Adverse Drug Reaction Reporting Systems; Adverse effects; Causality.

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