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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Date
2014
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Abstract
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.
Description
Master of Medical Science in Public Health Medicine. University of KwaZulu-Natal, Howard College 2014.
Keywords
Pediatric clinics -- South Africa., Intravenous therapy -- South Africa., Injections, Intravenous -- South Africa., Immunoglobulin idiotypes., Theses -- Public health medicine., Polyclonal intravenous immunoglobulin., Intravenous immunoglobulin (IVIG)