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

The International Journal of Pharmacy Practice
Joana MarquesJorge Polónia

Abstract

Reporting of adverse drug reactions (ADRs) may differ between countries. 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. 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 sys...Continue Reading

References

Feb 1, 1994·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·I R Edwards, C Biriell
Apr 29, 1998·JAMA : the Journal of the American Medical Association·J LazarouP N Corey
Dec 11, 1999·BMJ : British Medical Journal·G P AithalC P Day
Mar 16, 2000·Journal of General Internal Medicine·T K GandhiD W Bates
Apr 12, 2001·Journal of the American Pharmaceutical Association : APhA·D W Bates
May 19, 2004·Journal of Internal Medicine·H DormannE G Hahn
Nov 25, 2005·British Journal of Clinical Pharmacology·A VallanoJ M Arnau
Jan 6, 2006·European Journal of Clinical Pharmacology·Aline Lins CamargoIsabela Heineck
May 20, 2006·BMJ : British Medical Journal·Erik Eliasson
Oct 31, 2006·Pharmacoepidemiology and Drug Safety·Johanna UlfvarsonUlf Bergman
Sep 18, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Marie Lindquist
Mar 4, 2008·Basic & Clinical Pharmacology & Toxicology·Shadi BaniasadiGloria Shalviri
Jul 22, 2009·Pharmacoepidemiology and Drug Safety·Yoo Seob ShinChein-Soo Hong
Mar 9, 2011·Pharmacoepidemiology and Drug Safety·Dominik RottenkolberNet of Regional Pharmacovigilance Centers
Nov 26, 2011·Expert Review of Clinical Pharmacology·Ameeta ParekhDouglas C Throckmorton
Jan 19, 2012·The Annals of Pharmacotherapy·Greene ShepherdDianne Williams May

Citations

Sep 6, 2014·International Journal of Clinical Pharmacy·Stephane Steurbaut, Yolande Hanssens
Oct 6, 2015·Expert Opinion on Drug Safety·Kennedy Obebi Cliff-EriboH M Sammons
May 26, 2015·European Journal of Clinical Pharmacology·Cristiano MatosJoão Joaquim
Dec 21, 2016·Journal of Patient Safety·Francisco Batel-MarquesCarlos Alves
May 19, 2020·Expert Opinion on Drug Safety·Eva Rebelo GomesMaria Teresa Herdeiro
Nov 20, 2020·Journal of Clinical Pharmacy and Therapeutics·Ya-Fang ChengTzu-Cheng Tsai
Dec 8, 2020·Journal of Clinical Pharmacy and Therapeutics·Laila Carolina Abu EsbaAmjed Abu Alburak

Related Concepts

Nurses
Clinical Pharmacists
Physicians
Retrospective Studies
Severity of Illness Index
Adverse Drug Reaction Reporting Systems
Pharmacovigilance
Antibiotics
Gastrointestinal Diseases
Hospitals

Related Feeds

Antifungals (ASM)

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antifungals

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.