Audit of provincial IVIG Request Forms and efficacy documentation in four Ontario tertiary care centres

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Intravenous immunoglobulin (IVIG) is a blood product containing pooled, polyvalent, mostly IgG antibodies. While developed as a replacement product for primary immunodeficiency, its immunomodulatory effects have led to the expansion of its use (Lin et al.,2007; Callum et al.,2011). A 2012 audit conducted by the Ontario Regional Blood Coordinating Network (ORBCoN) demonstrated that 44.6% of IVIG prescribed is for unlabelled indications and 11.4% of use is for patients with conditions without guideline recommendations or research demonstrating efficacy, consistent with published literature (Leong et al.,2008; ORBCoN, 2012b). Because of its adverse effects, high cost and limited availability, interventions have been employed to ensure appropriate IVIG use. Despite these interventions, Canada still remains the highest per capita user (Chow et al.,2012).
In an attempt to limit inappropriate use, the Ontario Ministry of Health and Long‐Term Care (MOHLTC) introduced an IVIG Request Form in September 2010 (ORBCoN, 2012a). This initiative requires physicians to complete and submit the form to their transfusion medicine department prior to a first dose of IVIG and to resubmit the form every 6 months for ongoing use. The dosage of IVIG must also be adjusted for ideal body weight in obese patients with a dosing calculator, and the dose verified prior to release.
The Request Form has not had an impact on the rising use of IVIG, which has tripled over the last decade (Chow et al.,2012). One reason for this may be that a prescriber is not required to demonstrate that a patient meets criteria for either the diagnosis of the approved medical condition or the indication for IVIG use in that condition. When an indication is not listed on the form, it is classified as ‘other’ and the Request Form is to be reviewed by the hospital's transfusion medicine service. This practice is centre‐dependent, often occurring after administration of IVIG or not at all. In contrast, most drug approval and reimbursement processes require medical information prior to authorisation and evidence of benefit for ongoing use. Unlike other drugs associated with the potential for harm and high cost, these principles are not applied to IVIG in Ontario.
In an attempt to understand contributors to the increase in IVIG utilisation, we performed a retrospective audit in four Ontario hospitals, to determine the case mix of new IVIG requests, to authenticate the information provided on the forms and to determine if clinical efficacy of IVIG treatment was documented by its prescriber. We sought to determine whether IVIG is being used appropriately and whether clinical efficacy is monitored.
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