title: An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  none.
  
  
  BACKGROUND
  not relevant. .
authors.affiliation: espen.jimenez.solem@regionh.dk.
authors.forename: Siri
authors.initials: S
authors.lastname: Vinther
authors.forename: Pia
authors.initials: P
authors.lastname: Klarskov
authors.forename: Hanne
authors.initials: H
authors.lastname: Borgeskov
authors.forename: Perle
authors.initials: P
authors.lastname: Darsø
authors.forename: Anette Kvindebjerg
authors.initials: AK
authors.lastname: Christophersen
authors.forename: Bille
authors.initials: B
authors.lastname: Borck
authors.forename: Catrine
authors.initials: C
authors.lastname: Christensen
authors.forename: Melissa Voigt
authors.initials: MV
authors.lastname: Hansen
authors.forename: Natalie Monica Løvland
authors.initials: NM
authors.lastname: Halladin
authors.forename: Mikkel Bring
authors.initials: MB
authors.lastname: Christensen
authors.forename: Kirstine Moll
authors.initials: KM
authors.lastname: Harboe
authors.forename: Marie
authors.initials: M
authors.lastname: Lund
authors.forename: Espen
authors.initials: E
authors.lastname: Jimenez-Solem
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D000697:Central Nervous System Stimulants / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003718:Denmark; D003880:Dermatology / Q000706:statistics & numerical data; D065427:Factor Xa Inhibitors / Q000009:adverse effects; D005260:Female; D006748:Hospital Departments / Q000706:statistics & numerical data*; D006761:Hospitals / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007388:Internal Medicine / Q000706:statistics & numerical data; D000069478:Lisdexamfetamine Dimesylate / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009885:Ophthalmology / Q000706:statistics & numerical data; D010036:Otolaryngology / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011567:Psychiatric Department, Hospital / Q000706:statistics & numerical data; D012189:Retrospective Studies; D000069552:Rivaroxaban / Q000009:adverse effects; D014859:Warfarin / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D000697:Central Nervous System Stimulants; D065427:Factor Xa Inhibitors; D014859:Warfarin; D000069552:Rivaroxaban; D000069478:Lisdexamfetamine Dimesylate