An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions
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An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions. / Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne; Darso, Perle; Christophersen, Anette Kvindebjerg; Borck, Bille; Christensen, Catrine; Hansen, Melissa Voigt; Halladin, Natalie Monica Lovland; Christensen, Mikkel Bring; Harboe, Kirstine Moll; Lund, Marie; Jimenez-Solem, Espen.
In: Danish Medical Journal, Vol. 64, No. 1, A5315, 2017.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions
AU - Vinther, Siri
AU - Klarskov, Pia
AU - Borgeskov, Hanne
AU - Darso, Perle
AU - Christophersen, Anette Kvindebjerg
AU - Borck, Bille
AU - Christensen, Catrine
AU - Hansen, Melissa Voigt
AU - Halladin, Natalie Monica Lovland
AU - Christensen, Mikkel Bring
AU - Harboe, Kirstine Moll
AU - Lund, Marie
AU - Jimenez-Solem, Espen
PY - 2017
Y1 - 2017
N2 - INTRODUCTION:Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014.METHODS:All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively.RESULTS:A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome.CONCLUSION:The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad.
AB - INTRODUCTION:Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014.METHODS:All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively.RESULTS:A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome.CONCLUSION:The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad.
M3 - Journal article
VL - 64
JO - Danish Medical Journal
JF - Danish Medical Journal
SN - 2245-1919
IS - 1
M1 - A5315
ER -
ID: 182584964