Use of Polyclonal Intravenous Immunoglobulin at a Paediatric Referral Hospital in South Africa Between 2009 and 2012

J Clin Immunol. 2015 Oct;35(7):668-74. doi: 10.1007/s10875-015-0192-y. Epub 2015 Sep 14.

Abstract

Background: Polyvalent intravenous immunoglobulin (IVIG) is registered for a limited number of specific indications in South Africa but is increasingly being used for unregistered uses. No guideline exists nationally to monitor and control IVIG prescription, which results in its use in many clinical situations with varying levels of evidence.

Purpose: This study describes the registered and unregistered use, and cost of IVIG at a tertiary paediatric hospital in South Africa.

Methods: A cross sectional descriptive study design was employed. Data on all patients (0 to 18 years) who attended the hospital during a 39 month period from 2009 to 2012 as out- or inpatients and were dispensed IVIG, was obtained from the pharmacy dispensing and National Health Laboratory Service electronic databases, and supplemented by a patient record review.

Results: During the study period, 185 patients received at least one dose of IVIG and a total 916 issues (3641.5 g) were dispensed. In 70 (41 %) of the 171 patients (involving 398 IVIG issues, 46 %), the South African Medicines Control Council registered indications for its use were followed. IVIG accounted for between 1.6, 1.7 and 4.6 % of the annual pharmacy expenditure during this 3-year study period.

Conclusions: More than half of all IVIG dispensed at this paediatric hospital was used for unregistered indications. Considering the pressures on supply and the pharmaceutical costs, a more standardized, protocol-driven approach to the prescription of IVIG is called for.

Keywords: IVIG; Polyvalent intravenous immunoglobulin; South Africa; cost; registered and unregistered use; tertiary paediatric hospital.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Child, Preschool
  • Cost-Benefit Analysis
  • Drug Costs
  • Drug Utilization / statistics & numerical data*
  • Drug and Narcotic Control / legislation & jurisprudence
  • Female
  • Humans
  • Immune System Diseases / drug therapy
  • Immune System Diseases / epidemiology*
  • Immunoglobulins, Intravenous / administration & dosage
  • Immunoglobulins, Intravenous / economics
  • Immunoglobulins, Intravenous / therapeutic use*
  • Immunologic Factors / economics
  • Immunologic Factors / therapeutic use*
  • Infant
  • Legislation, Drug
  • Male
  • Off-Label Use / legislation & jurisprudence
  • Off-Label Use / statistics & numerical data*
  • Referral and Consultation
  • South Africa

Substances

  • Immunoglobulins, Intravenous
  • Immunologic Factors