alexa A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal.
Pharmaceutical Sciences

Pharmaceutical Sciences

Journal of Pharmacovigilance

Author(s): Marques J, RibeiroVaz I, Pereira AC, Polnia J

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Abstract OBJECTIVE: Reporting of adverse drug reactions (ADRs) may differ between countries. METHODS: In a retrospective descriptive study we analysed the potential causative drugs and clinical situations related to spontaneously reported ADRs over 10 years to a regional pharmacovigilance centre in Portugal. KEY FINDINGS: We collected 3165 cases (36\% of all national reports) of ADRs reported by doctors (54\%), pharmacists (31\%), and nurses (15\%), 56\% of which were classified as serious, 22\% as unexpected and 13\% as both serious and unexpected. According to World Health Organization causality criteria of ADRs related to drugs, 67\% where probable, 20\% possible, 7\% conditional, 6\% certain and 1\% unclassifiable or unlikely. There was a predominance of females (66\%, P < 0.005) both for total and serious ADRs. Physicians, while working in hospitals, reported more (68\%) and more serious ADRs (75\%) than those working in primary care (29\%). Pharmacists working outside hospitals reported more (90\%) than those working in hospitals. Drugs more frequently associated with ADRs were antibiotics (22\%), followed by vaccines (16\%), drugs acting on the nervous system (15\%), non-steroidal anti-inflammatory drugs (14\%) and those working on the cardiovascular system (11\%). The most common systems, organs or disorders affected by ADRs were skin manifestations (21\%), followed by general disorders (20\%), gastrointestinal/hepatobiliary disorders (15\%), nervous system disorders (11\%) and immune system disorders (6\%). CONCLUSIONS: Our study shows a general commitment of Portuguese health professionals to ADR reporting with a clear predominance of serious rather than non-serious ADRs. This study may help to improve the recognition of the general aspects of ADRs occurring in Portugal. © 2013 Royal Pharmaceutical Society. This article was published in Int J Pharm Pract and referenced in Journal of Pharmacovigilance

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