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

• Type: Article in International Conference Proceedings Book
• Date: 2014

Authors

marques, j (Author) Other; ribeiro-vaz, i (Author) Other; pereira, ac (Author) FMUP; polonia, j (Author) FMUP

Conference proceedings International

Title: International Journal of Pharmacy Practice

Pages: 275-282

Indexing

ISI Web of Knowledge

Scopus - 29 Citations

Other information

Authenticus ID: P-008-PVN

DOI: 10.1111/ijpp.12078

Abstract (EN): 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 7