Syri fined after supplying under-strength medicine to child
A court has fined the pharmaceutical manufacturer Syri Ltd over £50,000 and ordered it to pay costs of more than £100,000 after the company supplied an under-strength medicine that caused a child to fall seriously ill.
Aylesbury Crown Court's judgement was made after an investigation by the Medicines and Healthcare product Regulatory Agency. The investigation was triggered after a two-year-old girl, who suffers from a rare genetic disease, suffered multiple seizures and was admitted to hospital having been prescribed magnesium glycerophosphate to help prevent seizures.
The MHRA was alerted to the issue following a report from Milton Keynes University Hospital. The Agency found that the medicine supplied to the child only contained 12 per cent of the strength detailed on the prescription, which made it ineffective and caused the child's illness.
Inspectors from the MHRA found the methods used by Syri, which is based in Ruislip, Hillingdon, to make the medicine and the checks that were in place failed to meet “appropriate standards”. The company was convicted of supplying a medicinal product which was not of the nature or quality specified in a prescription.
The MHRA, however, said Syri had “improved their quality assurance procedures to prevent a recurrence”. The girl’s parents have the option of applying for compensation through the civil courts.
“Pharmaceutical companies such as Syri Ltd have a legal obligation to ensure they produce and supply medicines that work and are manufactured to the required standards,” said Dr Alison Cave, the MHRA’s chief safety officer.
“The patient has recovered, but the consequences could have been much more serious if it hadn’t been for the swift action of hospital staff. Patient safety is our top priority. The Agency will not hesitate to take robust enforcement action when serious failings that put patients at risk are identified.”