title: [Patient reporting of adverse drug reactions in Norway 2010-13].
abstract: BACKGROUND
  Since 1 March 2010, patients in Norway have had the opportunity to report adverse reactions to The Norwegian Medicines Agency. The purpose of this study was to review these reports.
  
  
  METHODS
  The content of adverse reaction reports received from patients in the period from 1 March 2010 to 31 December 2013 was classified based on age, gender, suspected drug and suspected adverse reactions. The patient reports were compared to the adverse reaction reports received from health care professionals in the same period.
  
  
  RESULTS
  A total of 755 reports from patients and 9629 reports from health care professionals were received during the period in question. The 20-39-year age group was most frequently represented in the patient reports. In the reports from health care professionals, the main age group was 0-9 years, followed by the 60-69-year age group. The drug group most often mentioned in the patient reports was drugs acting on the nervous system, and above all psychotropic drugs and analgesics, while vaccines dominated in the reports from health care professionals. Adverse mental and neurological reactions were most frequently reported by patients, while general symptoms and local reactions were most common in the reports from health care professionals. A total of 74 different adverse reactions were reported only by patients and not by the health care professionals.
  
  
  CONCLUSIONS
  Adverse drug reaction reports from patients are different from reports by health care professionals. Our findings indicate that the system with patient reporting functions as a supplement to reporting from health care professionals.
authors: Institutt for laboratoriemedisin, barne- og kvinnesykdommer Norges teknisk-naturvitenskapelige universitet.
authors: Kamilla
authors: K
authors: Fjermeros
authors: Institutt for laboratoriemedisin, barne- og kvinnesykdommer Norges teknisk-naturvitenskapelige universitet.
authors: Maren C Frogner
authors: MC
authors: Werner
authors: Seksjon for legemiddelovervåking Statens legemiddelverk.
authors: Pernille
authors: P
authors: Harg
authors: Seksjon for legemiddelovervåking Statens legemiddelverk.
authors: Hilde
authors: H
authors: Samdal
authors: Institutt for laboratoriemedisin, barne- og kvinnesykdommer Norges teknisk-naturvitenskapelige universitet og Avdeling for klinisk farmakologi St. Olavs hospital.
authors: Lars
authors: L
authors: Slørdal
authors: Institutt for laboratoriemedisin, barne- og kvinnesykdommer Norges teknisk-naturvitenskapelige universitet og Avdeling for klinisk farmakologi St. Olavs hospital.
authors: Olav
authors: O
authors: Spigset
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002491:Central Nervous System Agents / Q000009:adverse effects; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005221:Fatigue / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D009325:Nausea / Q000139:chemically induced; D009664:Norway / Q000453:epidemiology; D014612:Vaccines / Q000009:adverse effects
chemical_list: D002491:Central Nervous System Agents; D014612:Vaccines