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A review of the use of polyclonal intravenous immunoglobulin at a paediatric referral hospital in South Africa between 2009 and 2012.

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Introduction Polyvalent intravenous immunoglobulin (IVIG) is registered for a limited number of specific indications in South Africa but is increasingly being used for unregistered or off-label uses. No national evidence-based guidelines are available to guide clinicians with IVIG prescribing and against which use could be monitored. This results in IVIG being used in a range of clinical situations with questionable indications. Objectives and methods This study aimed to ascertain the registered and unregistered uses and cost of IVIG at a tertiary paediatric hospital in South Africa. A cross sectional descriptive study design was employed through a patient folder review, supplemented by data from the pharmacy electronic dispensing database, as well as the National Health Laboratory Service database. This study was conducted on all patients aged 0 to 18 years who were issued IVIG during a 39 month period from 2009 to 2012 within this facility. Results and discussion During the study period, 185 patients received at least one dose of IVIG and a total 916 issues (3642g) were dispensed. Use fell into the Medicines Control Council registered indications in 76 (44%) patients involving 416 (48%) issues. Only 87 (53%) of the patients were tested for HIV and in these the HIV sero-prevalence was 19%. The cost per patient amounted to ZAR15 937 in South African Rand. The highest IVIG issue-values were for Guillain-Barré syndrome (ZAR301 586), primary immunodeficiencies (ZAR340 953) and ‘other transplants’ (ZAR546 708). The annual cost for IVIG/1000 admissions adjusted for inflation was ZAR24 294, ZAR24 847and ZAR60 251 for 2009/2010, 2010/2011 and 2011/2012 financial years respectively. IVIG accounted for between 1.6%, 1.7% and 4.6% of the pharmacy expenditure per year in the study period. Conclusion More than half of all IVIG issued at this paediatric hospital was used off-label. Considering the pressures on supply and the pharmaceutical costs, manifesting as an increasing share of the pharmacy budget, a more standardised, protocol-driven approach to the prescription of IVIG is called for. It is recommended that further reviews are conducted to determine the evidence-base for the use of IVIG in the current off-label conditions.


Master of Medical Science in Public Health Medicine. University of KwaZulu-Natal, Howard College 2014.


Pediatric clinics -- South Africa., Intravenous therapy -- South Africa., Injections, Intravenous -- South Africa., Immunoglobulin idiotypes., Theses -- Public health medicine., Polyclonal intravenous immunoglobulin., Intravenous immunoglobulin (IVIG)