National High-Risk Medicines Classification

National Risk Medicines Classification

The National High-Risk Medicines Classification is an information product of Fimea that supports medication safety. The National High-Risk Medicines Classification lists high-risk medicines for which special attention should be given. The classification is intended for use by health care professionals and helps to identify key high-risk medicines in different health and social care settings. The classification supports clinical decision-making on pharmacotherapies and the planning and implementation of pharmacotherapies at different stages of the medication process.

National Risk Medicines Classification -logo: High-risk medicines.

Content of the National High-Risk Medicines Classification 

High-risk medicines may not cause more errors than other medicines but when they are misused or used in error, the consequences can be severe for the patient. However, these severe consequences can be mitigated or prevented by appropriate planning and implementation of pharmacotherapy. The National High-risk Medicines Classification describes: 

Serious consequences 

Serious consequences can be the result of the medicine itself or be related to deficiencies or human errors in the proper use of the medicine or the implementation of the medication. 

Significant risks 

The risk of medicines is mainly based on the characteristics of the medicine (e.g. narrow therapeutic area) or deficiencies or human error in the proper use of the medicine or in the implementation of the medication (e.g. errors in the administration or in the planning and monitoring of the medication). The classification does not consider the probability of risks or the effect of individual factors of the medicine user, such as age or kidney function. 

Risks related to the implementation of pharmacotherapy 

The risks related to the implementation of pharmacotherapy are divided into: 

  • Planning and prescribing pharmacotherapy  
  • Dosage 
  • Monitoring of pharmacotherapy 
  • and things that should consider in patient education and medication counselling.  

Possible risk points related to the implementation of medication are described for each step. 

Using the National High-Risk Medicines Classification 

The National High-Risk Medicines Classification is available to everyone free of charge. The classification is available in Finnish, Swedish and English. The content of the National High-Risk Medicines Classification is available as open data. Read more on the terms and conditions for Fimea's open data licenses CC BY 4.0.

Each health and social care organization must define the high-risk medicines that are central to them. The pharmacotherapy must be started, changed, or discontinued under the supervision of a physician. 

The National High-Risk Medicines Classification (Excel, updated 7/2024) 

The National High-Risk Medicines Classification (txt, instructions)
The National High-Risk Medicines Classification (XSD-schema)
The National High-Risk Medicines Classification (XML) 

EN Kansallinen riskilääkeluokitus (haitarit)

EN Kansallinen riskilääkeluokitus (ladattava materiaali)

Downloadable materials

The above-mentioned downloadable communication materials are not allowed to use in commercially. More information: [email protected].

Further information

Further information

Elsi Similä, Project Manager, Fimea, [email protected], tel. +358 29 522 3607

E-mail addresses follow the form [email protected]