CLINICAL AND LEGAL ASPECTS OF THE APPLICATION OF LOW-MOLECULAR-WEIGHT HEPARINS IN PEDIATRICS

The acceptability and effectiveness of low-molecular-weight heparin (LMWH) use in paediatrics has been confirmed by established Russian and foreign clinical practice. However, at present, the only LMWHs that are legally allowable for children are those with the international nonproprietary name of «dalteparin sodium», since this is directly stated in it’s Package Insert Leaflet (PIL). Prescribing the rest of the LMWHs for children will, in fact, be an off-label prescription. In addition, there are currently no standards of medical care, procedures for its delivery and regulations on the organization of medical care that would allow for the possibility of assigning LMWHs to children. This situation makes it difficult to introduce into the Russian pediatric practice the choice of administration of LMWHs in children where necessary. The use of LMWH in pediatrics may become available even without making changes to PIL, but subject to the establishment of such a recommendation in the new clinical guidelines. The latter is the only legal mechanism in force allowing legal and legally secure off-label appointment.