Coroner Warns of Baby Deaths Linked to Unlicensed Medicines
A recent inquest reveals risks associated with unreported adverse events from unlicensed medical providers in England.
- Three infants died in 2014 after receiving contaminated total parenteral nutrition (TPN) feeds in English hospitals.
- The contamination was caused by Bacillus cereus, a bacterium resistant to some cleaning methods.
- The coroner's report highlights inadequate reporting requirements for section 10 exempt entities under the Medicines Act 1968.
- ITH Pharma, a licensed provider, was fined £1.2 million in 2022 for related regulatory offenses.
- The report suggests that improved information sharing could prevent future incidents and requires responses by January 8.
The Guardian 
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Evening Standard 