Frequently asked questions

The preparation of the National High-risk Medicine Classification was guided by a project group of 14 members* in 2022–2023. The project group* consisted of medical, nursing and pharmacy experts: 

• Ari Ahola-Olli, asiantuntijalääkäri, Abomics Oy 
• Maarit Bärlund, ylilääkäri, syöpätautien poliklinikka, Pirha 
• Anne Halmetoja, klinikkaproviisori, HUS  
• Risto Huupponen, kliininen farmakologi, professori emeritus, Turun yliopisto  
• Marja Härkänen, apulaisprofessori (lääkitysturvallisuus ja hoitotiede), Itä-Suomen yliopisto  
• Johanna Jyrkkä, tutkimus- ja kehittämisasiantuntija, Fimea  
• Esa Jämsen, geriatrian professori, Helsingin yliopisto  
• Marianne Kuusisto, lääkitysturvallisuuskoordinaattori, Asiakas- ja potilasturvallisuuskeskus
• Outi Laatikainen, tutkijatohtori, Oulun yliopisto ja Oulun yliopistollinen sairaala  
• Carita Linden-Lahti, vastaava proviisori (lääkitysturvallisuus), HUS  
• Lotta Schepel, lääkitysturvallisuuspäällikkö, HUS  
• Elsi Similä, projektipäällikkö, Fimea  
• Terhi Toivo, lääkitysturvallisuuskoordinaattori, Pirha 
• Juho Wedenoja, kehittämisylilääkäri, Fimea 

The project group created a proposal for medicines to be included in the classification, using international lists of high-risk medicines (ISMP 2018, NPSA 2011, CEC 2015, DMA 2011) as well as HUS's list of high-risk medicines and other literature (Saedder et al. 2014). 

In addition to the expertise of the project group, the Delphi method (consensus method) was used. During the project, three Delphi survey rounds were carried out during the fall of 2022, and nearly 60 experts from the fields of medicine, pharmacy and nursing/nursing science participated. The study formed consensus on medicines to be included to the classification and their key risks. 

The National High-risk Medicine Classification has been prepared as a generic classification to serve the wide group of healthcare professionals from different health and social care settings. The classification does not consider the medicines such as anesthetic agents, medications used only in specialized environments or spinal and epidural medication. 

The classification has been prepared based on the medicine, and not from the point of view of risks arising from e.g. the environment or the patient group (e.g. children, pregnant women).

The classification does not consider the risk of confusion between Look-alike, sound-alike (LASA) medicines, medicines used for a disease or medical condition that it is not approved to treat (Off-label use), allergic reactions of medicines and the misuse of medicines. However, these and the risks related to different patient groups are described in medicine-specific texts if necessary.