National Risk Medicines Classification

In the national risk medicines classification, high-risk medicines refer to medicines that do not necessarily cause more hazardous situations than other medicines, but, if used incorrectly, their consequences may be serious for the patient (serious harm/injury, hospitalisation/prolongation of hospitalisation or death). The serious adverse effects caused by medicines can be prevented or at least significantly mitigated with the appropriate implementation of pharmacotherapy and monitoring of treatment.

Generic classification means that the classification is carried out at a general level and does not take into account specialty-specific medications such as anaesthetic agents, medications used only in intensive care and monitoring departments, or spinal and epidural medication.

The national risk medicines classification will be drawn up medication-specifically, e.g., from the perspective of risks arising from the pharmacotherapy environment or patient group (e.g. children, pregnant women). The risk of medicines to be classified is mainly based on the characteristics of the medicinal product (e.g. its narrow therapeutic area) or deficiencies or human error in the proper use of the medicinal product or in the implementation of the treatment (e.g. errors in the administration of the medicinal product, such as accidental overdose or wrong route of administration or errors in the planning and monitoring of the pharmacotherapy in question).

The classification does not take into account the risk of confusion between medicinal products that look and sound like others (LASA), the prescription of medicinal products for uses other than those mentioned in the summary of product characteristics (Off-label use), allergic reactions to medicinal products, or intentional misuse of medicinal products. However, these risks and those associated with different patient groups will be described in the texts specific to the pharmaceutical substance/group, if necessary.