M W Lin1, P E Kirkpatrick, D S Riminton. 1. Department of Immunology, Concord Repatriation General Hospital, Concord, New South Wales, Australia.
Abstract
BACKGROUND: The clinical demand for i.v. immunoglobulin (IVIg) continues to increase in Australia for reasons that are not clear. IVIg is distributed for approved indications according to Australian Health Ministers' Advisory Council 2000 guidelines that are currently under review. IVIg may also be purchased by hospitals for uses not covered by these indications on an individual patient use basis. These audits were developed to examine current hospital practice in IVIg use. METHODS: Six-month prospective audits of all IVIg use were conducted at two teaching hospitals in Sydney (Concord and Royal Prince Alfred Hospitals). Medical files and dispensing records were examined and compared with current guidelines. RESULTS: One hundred and sixty-five recipients received 24,251 g of IVIg (mean total use 147 g/patient) for 36 distinct diagnoses, with 5.5% mortality. Drug committees supplied 1580 g of IVIg (6.5% of total product issued) to 12 recipients (7.3% of total recipients). The clinical specialties of immunology, haematology and neurology accounted for 92.9% of IVIg use, with 51.8% of overall use for replacement indications. Forty-two patients (25.5%) received IVIg for non-category 1 indications (4718 g, 19.5% of total product). Patients receiving IVIg for category 1 disorders had a 94.4% compliance with the guideline prerequisites where data were sufficient for assessment. DISCUSSION: Our findings show a greater than expected proportion of non-category 1 IVIg use and substantial contributions from drug committees. Careful case selection within category 1 indications is evident in the high level of compliance with qualifying criteria. Current distribution procedures do not enable capture of outcome data to inform guideline revisions. CONCLUSION: These audits emphasize the requirement for updated National Clinical Practice Guidelines, improved approval procedures, consensus statements in the specialties of immunology, haematology and neurology and clarification of the role of drug committees.
BACKGROUND: The clinical demand for i.v. immunoglobulin (IVIg) continues to increase in Australia for reasons that are not clear. IVIg is distributed for approved indications according to Australian Health Ministers' Advisory Council 2000 guidelines that are currently under review. IVIg may also be purchased by hospitals for uses not covered by these indications on an individual patient use basis. These audits were developed to examine current hospital practice in IVIg use. METHODS: Six-month prospective audits of all IVIg use were conducted at two teaching hospitals in Sydney (Concord and Royal Prince Alfred Hospitals). Medical files and dispensing records were examined and compared with current guidelines. RESULTS: One hundred and sixty-five recipients received 24,251 g of IVIg (mean total use 147 g/patient) for 36 distinct diagnoses, with 5.5% mortality. Drug committees supplied 1580 g of IVIg (6.5% of total product issued) to 12 recipients (7.3% of total recipients). The clinical specialties of immunology, haematology and neurology accounted for 92.9% of IVIg use, with 51.8% of overall use for replacement indications. Forty-two patients (25.5%) received IVIg for non-category 1 indications (4718 g, 19.5% of total product). Patients receiving IVIg for category 1 disorders had a 94.4% compliance with the guideline prerequisites where data were sufficient for assessment. DISCUSSION: Our findings show a greater than expected proportion of non-category 1 IVIg use and substantial contributions from drug committees. Careful case selection within category 1 indications is evident in the high level of compliance with qualifying criteria. Current distribution procedures do not enable capture of outcome data to inform guideline revisions. CONCLUSION: These audits emphasize the requirement for updated National Clinical Practice Guidelines, improved approval procedures, consensus statements in the specialties of immunology, haematology and neurology and clarification of the role of drug committees.