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14/08/2018

GP practice could close after failure to warn women of risks around sodium valproate

A GP practice in London could be closed down after inspectors found that staff had failed to warn women of the risks around the epilepsy medication sodium valproate during pregnancy.

An alert relating to sodium valproate had been recorded at the Staunton Group Practice in Wood Green which is registered to provide family planning, maternity and midwifery services.

But inspectors from the Care Quality Commission said that four out of five women of child bearing age who had been prescribed the drug without contraceptive measures, had not been informed of the risks associated with the drug during pregnancy.

GP practice could close

Staunton Group Practice CQC report 

Effects of sodium valproate on unnborn baby

Up to 40 per cent of babies exposed to sodium valproate during pregnancy are born with a physical disability or developmental problems.

In March this year new regulations came into effect across Europe which mean that women of childbearing age can no longer be prescribed sodium valproate unless no other treatment is effective. Full contraceptive advice must also be given.

CQC raises alarm

Epilepsy Society's chief executive, Clare Pelham, praised the diligence of the CQC in identifying the failure of the GP practice to warn women with epilepsy of the risks around the drug.

But she warned this could be the tip of the iceberg if an awareness programme run by the Medicines and Healthcare products Agency (MHRA) proves ineffective. And she has written to the agency's chief executive  asking what lessons have been learnt from the CQC report and what changes  they will make to policies and pratices as a consequence (see letter below).

"It has taken years to ensure that mandatory regulations are introduced safeguarding babies from being born with avoidable disabilities," she said.

"And all credit to this Government for listening to mothers, campaigners and families affected. But the Government relies on the MHRA to make the changes happen. We warned the MHRA that it would take an imaginative and comprehensive communication programme to bring about change.

Learn lessons from the past

"Failings at the Staunton Group Practice show that the message is not reaching at least some doctors on the front line. And the heart-breaking consequence may be babies born with avoidable disabilities.

"We must learn the lessons of ineffective communications in the past. An earlier 'toolkit' was issued by the MHRA to women prescribed sodium valproate, but a survey by Epilepsy Society, Epilepsy Action and Young Epilepsy showed that 70 per cent of the target audience of women taking sodium valproate, had not received it. We cannot sit by and let history repeat itself.

"The Government has done well. The CQC has done well. But the MHRA must do better. The question is, who regulates the regulators?

Need for hard-hitting campaign

"We cannot wait for more GP practices to be identified by the CQC. The MHRA needs to step up communications with a hard hitting awareness campaign that is loud, clear and unavoidable on the notice boards of every GP waiting room across the UK.

"We cannot depend on CQC inspectors to step in and make sure women with epilepsy are given information that is critical to the well being of their future children."

The failure at the Staunton Group Practice is one of a series of problems flagged up by the health watchdog. The practice is now being run by a different healthcare provider and the CQC has warned that if improvements are not seen within six months, they will consider closing the practice.

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