Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data

Experiences from the adverse drug event manager

“…If the system is to be more effective, reporting ADRs must be as natural as ICD-10 coding. 6 The majority of reports concerned classical type A side effects, but the ADEM was also able to detect interesting signals such as pharmacodynamic and kinetic drugdrug interactions as well as drugfood interactions. 7,8 Thus, the ADEM has also been a benefit to the teaching environment for resident physicians in clinical pharmacology.…”

“…Although the number of spontaneous reports has increased markedly, there is still a significant element of underreporting of ADRs. If the system is to be more effective, reporting ADRs must be as natural as ICD-10 coding 6 . The majority of reports concerned classical type A side effects, but the ADEM was also able to detect interesting signals such as pharmacodynamic and kinetic drug–drug interactions as well as drug–food interactions 7,8 .…”

“…It has elucidated both the power and peril of the spontaneous reporting system and inspired a range of epidemiological studies. 1,5,6,[9][10][11][12][13][14][15][16][17] The ADEM function has learned that the following factors are crucial in increasing the number of reports from healthcare professionals 18 Visibility of the ADEM Management support Professional knowledge Time Knowledge of the procedure for reporting ADRs.…”

“…Thus, the ADEM has also been a benefit to the teaching environment for resident physicians in clinical pharmacology. It has elucidated both the power and peril of the spontaneous reporting system and inspired a range of epidemiological studies 1,5,6,9–17 …”