Cost-of-illness study of severe haemophilia A and B in five French haemophilia treatment centres.

OBJECTIVE: The aim of this study was to assess the consumption of anti-haemophilic drugs by adults and children with severe haemophilia A or B (residual activity of FVIII or FIX < or =2%) and to quantify the average direct medical costs. METHOD: A retrospective multicentre cost-of-illness study from the perspective of French national health insurance system. The costs include only the use of clotting factors. MAIN OUTCOME MEASURE: Consumption was expressed in UI/kg/year and costs in euros/kg/year. RESULTS: From January 1, 2001 to December 31, 2002, data from 81 adults and 30 children with severe haemophilia A (n = 92) or B (n = 19) and included in the "SNH" were collected and analysed. A coagulation factor inhibitor was present in 10 patients (9%). Four of them were high responders. Mean age and body weight were respectively 28 +/- 17 years and 58 +/- 24 kg. Except for one adult patient, all (99%) had outpatient treatment, 44 patients (40%) were hospitalized and treated by recombinant or/and plasma-derived FVIII or FIX or/and rFVIIa. Overall median annual consumption of anti-haemophilic drugs per patient was estimated at 1,333 UI/kg, with a median cost-of-illness of 1,156 euros/kg. Patients with severe haemophilia B consumed more than patients with severe haemophilia A, though not significantly (P = 0.096), with a median of 2,167 vs. 1,100 UI/kg/year and a median cost of 1,760 vs. 917 euros/kg/year (P = 0.13). Children consumed respectively more than adults (P = 0.008), with a median of 3,204 vs. 1,106 UI/kg/year and a median cost of 2,614 vs. 913 euros/kg/year (P = 0.012). The median cost for patients with an inhibitor was 3,291 euros/kg/year, approximately threefold higher than that of patients without an inhibitor (926 euros/kg/year) (P = 0.022). CONCLUSION: It suggests a higher consumption and cost of anti-haemophilic drugs among children when compared to adults. Haemophilia B patients did not consume significantly more than haemophilia A patients, whereas the consumption and cost for patients with or without inhibitors differed significantly.

Observational study of potential risk factors of medication administration errors.

OBJECTIVE: Medication administration errors (MAEs) are the second most frequent type of medication errors, as has been shown in different studies in the literature. The aims of this observational study were to assess the rate and the potential clinical significance of MAEs and to determine the associated risk factors. DESIGN: In two departments, Geriatric Unit (GU) and Cardiovascular-Thoracic Surgery Unit (CTSU) of Besançon University Hospital (France), MAEs were identified using the undisguised observation technique and classified according to the definitions of the American Society of Health-System Pharmacists. Injectable administration, lack of nurses's standardized protocol for the preparation and administration of drugs, incomplete or illegible prescription and nurse's workload were analysed as potential risk factors of MAEs in multivariate logistic regression analysis. RESULTS: During a period of 20 days, opportunities for error concerning 56 patients and 78 MAEs (58 in CTSU and 26 in GU) were observed. The medication administration error rate was 14.9%. Dose errors were the most frequent (41%) errors, followed by wrong time (26%) and wrong rate errors (1996). No potential fatal errors were observed, 8 (10%) were estimated as potentially life-threatening, 20 (26%) potentially significant and 50 (64%) potentially minor. Nurse workload and incomplete or illegible prescriptions were two independent risk factors of MAEs. CONCLUSION: According to these data, the quality of the medication administration process needs to be optimized in hospitals in order to minimize the incidence of iatrogenic preventable diseases.

Factor XIII replacement in stem-cell transplant recipients with severe hemorrhagic cystitis: a report of four cases.

BACKGROUND: Hemorrhagic cystitis (HC) is an important cause of morbidity in patients undergoing allogeneic stem-cell transplantation (SCT). Various causes have been identified, such as the use of high-dose cyclophosphamide or busulfan and the occurrence of acute graft-versus-host disease or viral infections (cytomegalovirus, adenovirus, polyomavirus). METHODS: The clinical course of four patients treated with factor XIII (FXIII) concentrate for severe HC after allogeneic SCT is described. RESULTS: Four patients were treated with one or two infusions of 50 IU/kg of FXIII concentrate. Only one patient showed a plasmatic FXIII decrease before treatment. Three of the four patients responded to this treatment, and HC completely resolved in two of them. No adverse event was observed. CONCLUSION: The use of FXIII concentrate can improve the major symptoms of HC in patients with decreased or normal FXIII plasma level after allogeneic SCT.