DI-087 Overuse of vitamin k-dependent clotting factors and corrective actions

BackgroundProthrombin complex concentrates (PCC) are prescribed for treating haemorrhagic risks or accidents under antivitamin K (AVK) or new oral anticoagulant (NEOC) treatment.In our hospital, a 45% rise in administration of PCC between the first semesters of 2014 and 2015 was noticed in the context of just in time distribution.Consideration of good use recommendations for these drugs were evaluated since our prescription software did not show any use outside of marketing authorisation (MA).PurposeTo determine the proportion of prescriptions of PCC outside MA, and describe them. To quantify the prescription of PCC pertaining to an overdose of NEOCs.Material and methods51 patients received PCC during the first semester of 2015 in our hospital. The medical records of these patients were analysed looking for the following information: general data (age, weight, creatinine clearance), anticoagulant treatment (drug and posology), blood test results (international normalised ratio (INR) and activated partial thromboplastin time), and data about PCC treatment (drug used, therapeutic indication according to the clinical condition, posology, date and time of injection, and association of vitamin K treatment).ResultsThe use of PCC was outside MA for 17 patients, which is an overuse of 33%, uselessly exposing them to a risk of thromboembolic disease.Among those 17 patients:8 (47% of outside MA administrations) had an asymptomatic overdose in AVK, the INR being judged too high;6 (35% of outside MA administrations) had non-serious haemorrhage; and 3 (18% of outside MA administrations) had to undergo surgery in more than 24 h.In each case, our national authority for health and and the summary of product characteristics (SPC) recommended using vitamin K only.Among the 51 patients who received PCC, only 3 had a haemorrhage under NEOCs (