Sammanfattning
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.
MATERIAL AND METHOD 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.
INTERPRETATION 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.