Use of non-specific intravenous human immunoglobulins in Spanish hospitals; need for a hospital protocol

作者：Ruiz Antoran Belen^*; Escasany Antonia Agusti; Vallano Ferraz Antoni; Danes Carreras Imma; Riba Neus; Mateu Escudero Silvia; Costa Joan; Sanchez Santiago Ma Blanca; Laredo Leonor; Duran Quintana Jose Antonio; Ramon Castillo Juan; Abad Santos Francisco; Payares Herrera Concepcion; Sadaba Diaz de Rada Belen; Gomez Ontanon Eugenio

来源：European Journal of Clinical Pharmacology, 2010, 66(6): 633-641.

DOI：10.1007/s00228-010-0800-y

• Intravenous immunoglobulin
• Drug utilization study
• Off-label use
• Compassionate use
• Cost

Intravenous immunoglobulin (IVIG) use in non-approved indications, the increase in consumption and its high cost recommend rationalisation in its utilisation.
To assess the use of IVIG in Spanish hospitals.
An observational, prospective and multicentre drug utilisation study was conducted in 13 tertiary Spanish hospitals. Data were collected for 3 months in patients receiving any IVIG. Patient demographics, indication for IVIG use, dosage regimen and cost of treatment were collected.
Five hundred and fifty-four patients (mean age of 52 years) were included in the study. A total of 1,287 prescriptions were administered, and the average number of prescriptions per patient was 2.3. The mean daily dose was 24 g (range 0.6-90 g). Overall, IVIG was prescribed for authorised indications in 335 patients (60%) with 953 prescriptions (74%), for non-authorised indications with scientific evidentiary support in 86 patients (16%) with 137 prescriptions (11%), and non-authorised and non-accepted indications in 133 patients (24%) with 197 prescriptions (15%). The most frequent authorised indications were primary and secondary immunodeficiencies, and the most frequent non-authorised and non-accepted indications were multiple sclerosis and bullous dermatosis. The mean cost of IVIG per patient for authorised indications was 2,636.2 a,not sign, non-authorised indications with scientific support 5,262.1 a,not sign and non-accepted indications 3,555.8 a,not sign.
IVIG is prescribed for a significant number of non-authorised and non-accepted indications with a notable cost. There is an important variability in IVIG prescriptions between hospitals, indicating room for improvement in IVIG use and the need for a consensus of protocol use.

• 出版日期2010-6