Investigation into Bacillus cereus infections associated with Lipid Phase Parenteral Nutrition manufactured by ITH Pharma
- Last Updated on 11 June 2014
Information for BAPEN Members 9.6.14
Last week, the Medicines Healthcare Regulatory Authority (MHRA) issued a drug alert calling for the recall of some lipid phase parenteral nutrition products that have been produced by ITH Pharma. This is following the reporting of a number of cases of Bacillus cereus septicaemia in neonates. The only link between these cases is that the lipid phase of the parenteral nutrition was prepared by ITH Pharma.
ITH Pharma are a well-known company providing aseptic services to hospitals including the provision of parenteral nutrition to adults, paediatrics and neonates. They have extensive experience in this field and are regularly reviewed and inspected by the MHRA to ensure that they are working to the legislation and to good manufacturing practice.
The MHRA performed an all-day inspection at ITH Pharma with two inspectors and there were no reported problems. They have not sought to suspend, or change the process of, aseptic manufacture carried out at ITHPharma. This suggests that the contamination incident is being viewed by the investigators as being a single incident which has been contained. Investigations are on-going but it is advised that you can legitimately continue to purchase products from ITH Pharma until the MHRA advises otherwise.
At this point in time we are not aware of the actual cause of the problem as this has not been established.
At the present time, the advice is to continue to manufacture or outsource parenteral nutrition according to local practice and that patients are reviewed for infections as is current practice,
We would also recommend that patients are reassured about the checks and environmental controls to minimize contamination that are in place for the compounding of their parenteral nutrition, and that currently there is no evidence that they will be at risk of getting this infection.
Further advice can be obtained from regional Quality Assurance Pharmacists on this incident. We will continue to update you as the investigation into the root cause of the incident is determined.
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