IMPACT OF THE NEW RECOMMENDATIONS IN THE USE OF PROTHROMBIN COMPLEX CONCENTRATES AND VITAMIN K ANTAGONISTS IN FRANCE- ILLUSTRATION OF THE GUIDELINES RESPECT IN HOSPITAL AND ITS ECONOMIC CONSEQUENCES

Author(s)

Bernard M, Mimoun G, Arnaud P, Peytavin GBichat-Claude Bernard hospital, Paris, Ile de france, France

OBJECTIVES: New recommendations were elaborated in April 2008 in France regarding overdoses, situations of hemorrhagic risk and bleeding accidents occurring in patients treated with vitamin-K antagonists (VKA). Considering the necessity for hospitals to guarantee the good therapeutic use of drugs to obtain reimbursement by public health insurance, and with the significant increase of prescriptions in 2008, a systematic follow-up of correspondence between prothrombin complex concentrates use (PCC, Kaskadil®) and current guidelines was analyzed. METHODS: A prospective study of patients treated with PCC in 2008 was conducted. Data collected included demographic, therapeutic (indication, dosage), biological (INR, PT), clinical (bleeding, surgery…) and pharmacoeconomic parameters. Results are expressed as median and interquartile range (IQR 25-75). RESULTS:  Ninety-one patients (41 men, median age: 76 years) received PCC, namely +78.4% compared to 2007, for a total cost of €81K (+73%). Analysis of prescriptions reveals that indications corresponded to the marketing authorisation (MA): 36% of bleeding under VKA, 30% of urgent surgery or invasive procedure and 29% of overdose (INR>5). Fluindione was the mainly prescribed VKA (77%). Median values of INR were 4 (2.9-6.9) and PT 33.5% (24-54%). Median doses of PCC were in accordance with MA and recommendations: 18.6 UI/KG (14.2-19.6) for patients undergoing urgent surgery, 22.3 UI/KG (19.2-24, n: 41) for patients with overdose. In 66%, a risk factor of overdose was identified: age>75 years (63%), comorbidity (15% like diabetes). The median cost of PCC treatment was €888/patient (€592-€888) representing 9.3% of the total hospitalisation cost paid by national health insurance for those 91 patients. CONCLUSIONS: PCC was used according to the recommendations and in respect of the health care regulations for reimbursement. The high increase of prescription observed in 2008, mainly in the emergency department (48%), can be explained by a change of medical practices and prescribing behaviour since the new recommendations.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PSY55

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Prescribing Behavior, Treatment Patterns and Guidelines

Disease

Systemic Disorders/Conditions

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