Background. The generalization of indications and the prescriptions of endovenous immunoglobulins (EVIG) has stimulated us to analyse in collaboration with the Hospital Pharmacy Department the rational prescriptions of EVIG in a general tertiary reference hospital.

Patients and Methods. Observational retrospective study performed in a general hospital with 1300 beds. We have analysed all EVIG prescriptions during 01-01/31-12-2003.

Data source: clinical reports, registries from Pharmacy Department, special application form for drugs and the compassionate use request made to Spanish Department of Health.

Variables: age, gender, weight, diagnosis/indication, dosage regimes, immediate complications, Department prescript and number of administrations. The indications of EVIG are classified in: A, authorized by the Spanish Association of Drugs (SAD). B, non authorized by SAD but scientific endorsed in specific situations. C, no recognized by SAD, its use is doubtful. D, inadequate.

Results. Total number of patients receiving EVIG for first time: 49 (M: 29; F: 20), 11 children (1 day– 16 years) and 38 adults (25–80).

Total number of doses: 261. In 9 cases the therapy continued in 2004 and 8 patients died by complications of their disease. The authorized indications were 37 (75,5%), non authorized 5 (10,2%) and non recognized 7 (14,3%). 12 cases needed compassionate prescription but only one was filled up.

Indications: Idiopatic Thrombocytopenia Purpura: 17 (34,7%), Guillain-Barré: 6 (12,2%), post-Bone Marrow Trasplantation: 5 (10,2%), immunodeficiency associated to Chronic Lymphoid Leukaemia-B: 3 (6,1%), Evans Syndrome 1, common variable immunodeficiency 1, Autoimmune Haemolytic Anaemia 1. Prescriptor Haematology Department 28 (55,1%), Neurology 12 (24,5%), Pediatry 9 (16,5%), y Internal Medicine 1.

Adhesion to authorized indications: 92.6% Haematology, 50% Neurology and 66.6% Pediatry. The doses fit in with the recommendations (0,4 g/kg) in 44 patients (89.8%), 3 cases under-dose (6.1%) and 2 overdose (4.1%). The infusion line was not like the recommendations in 3 cases (6,1%) and in 2 (4,1%) was modified because of pressure of patients. The application form was not filled in properly in 23 cases (46.9%). 8 patients developed some type of adverse effect associate to the infusion of EVIG in the first 24 hours.

Conclusions: Rate of adequacy to authorized indications was high and the procedure of the compassionate use in the rest indications was low. The dose and infusion line were fitted in with the recommendations in most of patients.

Proposals to improve: a) Protocol review, elaboration and diffusion of guidelines about EVIG indications. B) To update the application form, including authorized indications, planning of different steps, dosage of EVIG and administration rules guideline C) To elaborate and provide to the patients an informative guide about EVIG characteristics, indications and adverse effects.

This study has been supported by a grant from FEHHA

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