Pattern of intravenous immunoglobulins (IVIG) use in a pediatric intensive care facility in a resource limited setting

Abstract

Background: Intravenous Immunoglobulin (IVIG) preparations are scarce biological products used for replacement or immunomodulatory effects. Guidelines have been issued by regulatory health authorities to ensure provision of the products for patients who are in severe need. Objectives: The study aimed at description of the pattern of IVIG use (label/off label indications), adverse effects observed, reason for choice of IVIG among other modalities and efficacy in a pediatric intensive care setting. Methods: A retrospective chart review. Patients: The study included 45 cases admitted from 2008 through 2011 in a Pediatric Intensive Care Unit (PICU) of a tertiary referral pediatric hospital. Results: The clinical diagnoses included neurology (35%), neonatology (16%), hematology (11%), autoimmune disorders (11%) immunodeficiency disorders (11%), infections other than neonatal sepsis (9%) and cardiology (6.5 %). The indications for IVIG use had an Evidence category Ia / Ib in 62 % of cases whereas the other 38 % had level II and III evidence. Choice of IVIG as a therapeutic option was based on failure of other treatment options to achieve response in 46.5%, lack of alternative treatment options 15.5 % and the need for urgent response in 38 %. Adverse events, duration and doses are reported. Conclusion: IVIG use is governed by availability of alternative options and the need for urgent response in critically ill children. Guidelines should be issued based on locally available treatment options and their cost effectiveness.

Evidence-based evaluation of intravenous immunoglobulin utilization in paediatric patients in Qatar

“…[13] A retrospective chart review of 45 patients admitted from 2008 to 2011 in a pediatric intensive care unit (PICU) of a tertiary paediatric hospital in Egypt reported that 35% of prescribed IVIG was under neurology. [1] Moreover; a 6-month review conducted in Iran found that neurologists were the most prevalent prescribers (39.6%). [4] Regarding appropriateness of IVIG dosing for the indication being prescribed for, inappropriate dosage was very low (2.4%; 8/342).…”

“…A retrospective chart review of PICU patients in Egypt reported that indications for IVIG use had an evidence category Ia/Ib in 62% of cases while the remaining 38% had level II and III evidence. [1] Another retrospective review done in Saudi Arabia showed that 35.7% of non-FDA-labelled indication had category D of evidence (i.e. there is no evidence to support IVIG use in their management).…”

“…Intravenous immunoglobulin (IVIG) is a pooled human plasma protein that showed efficacy in treating a variety of disorders. [1,2] IVIG has been approved by the Food and Drug Administration (FDA) for six conditions: (1) primary immunodeficiency disease (PID), (2) idiopathic/immune-mediated thrombocytopenic purpura (ITP), (3) human immunodeficiency virus (HIV), (4) bone marrow transplantation, (5) Kawasaki disease and (6) chronic lymphocytic leukaemia (CLL). [3] Despite of this, IVIG had been tried and administered in nearly 100 conditions.…”

“…[2] . For that reason, IVIG remains an important research topic in many medical centres for three main reasons: (1) its efficacy in treating a variety of disorders is controversial, (2) chronic shortages of IVIG products have negatively impacted patient care, and (3) IVIG is an expensive medication (estimated cost per gram $50). [4] Previous drug use evaluation studies of IVIG worldwide showed there is big percentage of patients were receiving IVIG for either not recommended indications or there is no convincing evidence of benefit.…”

“…Thus, the main objective of this study was to determine the level of evidences supporting IVIG indications used in paediatric patients in Qatar. Secondary objectives were as follows: (1) to evaluate the current practice and utilization of IVIG in paediatric department patients in Qatar and (2) to identify the appropriateness of IVIG dosage regimen used for each indication.…”