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Methicillin-resistant Staphylococcus Aureus

Answer

The Department was informed by Novartis on 23 February 2009 that staphylococcus aureus bacterial contamination had been found in samples of the solvent used in meningitis C vaccine. The material in question had not been distributed in the United Kingdom but came from the same manufactured batches that had been distributed in the UK. The Department reminded Novartis of its statutory responsibility to inform the Medicines and Healthcare products Regulatory Agency (MHRA). Novartis contacted the Defective Medicines Report Centre (DMRC) at MHRA on 24 February by telephone initially, then followed up with an e-mail.The MHRA issued a class 2 drug alert on 25 February 2009. The drug alert informed recipients of the issue and identified potentially affected batches.On the evening of 25 February 2009 a chief medical officer (CMO) message was sent via the central alert system (formerly known as the public health link) as a class 1, immediate action alert, for immediate cascade (within six hours) to relevant health professionals, including general practitioners (GPs) and practice nurses, accident and emergency departments and community pharmacists. At the same time a pager message was also sent that evening to all recipients of the CMO message, instructing them to immediately cascade this information to all relevant health professionals. Local immunisation co-ordinators are direct recipients of CMO messages via the central alert system, and would have received the electronic alert that night.The Department's immunisation team separately contacted all primary care trusts immunisation co-ordinators on the evening of 25 February and informed them of the GP surgeries in their areas that had received the batches to be withdrawn.The MHRA has arranged for additional sterility tests to be carried out on the affected solvent batch in the UK. A total of 120 solvent samples will be tested. The MHRA is awaiting delivery of test samples. Sterility testing takes at least 14 days, so the date on which the tests are completed will depend on when the samples are put on test. The MHRA understands that Novartis are testing an additional 360 solvent samples. Novartis testing started on 26 February 2009 and will be completed on 13 March 2009.

Secondary information

Type

Written question

Reference

489 c116-7W;489 c117-8W; 260596

Session

2008-09

Notes

Question answered on the 4 March 2009 but printed in the Daily Part and the Bound Volume for 9 March 2009.

Subjects

MRSA

Link

View this Written question on www.publications.parliament.uk