Background Probiotic supplementation significantly reduces the risk of mortality and ≥ Stage II necrotising enterocolitis in preterm neonates. (Deshpande et al Lancet 2007, Pediatrics 2010). Based on the current evidence, experts favour routine probiotic supplementation in preterm neonates, if safe and effective products are available. We implemented a stepwise plan to introduce probiotics in our regional tertiary neonatal centre.
Step wise approach:
Comprehensive literature review to develop evidence based guidelines for optimal use of probiotics in preterm neonates.
Identifying a suitable product based on the systematic review of RCTs in preterm neonates, and probiotics listed by Therapeutic Goods Administration, (TGA).
Approval of selected probiotic product (Infloran) from local area drug and therapeutics committee.
Endorsement from local Ethics Committee.
Authorised Prescriber application to TGA via Pharmacy Department.
Approval from authorities regarding importing probiotic product from overseas.
Independent quality assessment (Taxonomy confirmation, antibiotic susceptibility, and osmolarity).
Further assessment for ruling out contamination from a TGA approved laboratory.
Results 2/19 locally available products were potentially appropriate for use in preterm neonates but turned out suboptimal in quality despite manufacturer’s data. (Patole et al PSANZ 2010) An overseas proven probiotic product was selected (Infloran) and imported after following above stepwise approach. After vigorous quality assessment Infloran was introduced routinely in preterm neonates at Nepean Hospital Sydney.
Conclusion Safe and effective probiotic product is accessible in Australia for routine use in preterm neonates. Further co-operation is needed between industry, regulatory authorities and clinicians to simplify this process.
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