Adverse incidents with medicines
An adverse incident with medicines or another healthcare product (e.g. blood product, tissues, cells or a medical device) refers to an incident or an error occurring in relation to healthcare activities or in relation to information about- or supply of medicines. Examples could be dosage errors, incorrect administration routes, confusions of products and similar.
An adverse incident is defined as being harmful, or potentially harmful, to the patient and is not due to the patient's disease.
A distinction is made between adverse drug events and adverse drug reactions.
Adverse drug events could be dosage errors, incorrect administration of the medicine or mix-ups of product names or packaging.
In Denmark, healthcare professionals in the primary and secondary sectors have an obligation to report adverse drug events and incidents with medical devices and other healthcare products.
Adverse incidents must be reported Danish Patient Safety Database via The Danish Healthcare Quality Institute.
It is also possible to report problems associated with the use of medicine, medical devices or suspicion of drug misuse to The Danish Medicines Agency:
Problems associated with the use of medicine, medical devices or suspicion of drug misuse
The task is transferred from the state to the regions
An agreement has been reached whereby the task with adverse incidents is transferred from the state to the regions.
With the agreement, Danish Regions will continue the work with the database for adverse incidents from May 1st 2025, which so far has been run by the Danish Patient Safety Authority.