The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance on full pack dispensing for medicines containing valproate, with regulation changes now in effect.
The legislation was amended after a government consultation determined that patients should always receive safety warnings – including a patient card and patient information leaflet contained in full packs – on the risks of sodium valproate to unborn babies.
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Prescribing to women and girls of childbearing potential must fulfil the conditions of the Valproate Pregnancy Prevention Programme, which is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.
The new legislation allows pharmacists to round the prescribed amount of valproate-containing medicines either up or down so that the patient receives only complete packs. The medicines must not be repackaged into plain dispensing packaging.
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Dr June Raine, MHRA chief executive, said: 'It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed. The changes in the law announced today ensure this happens.
'People’s situation may change, especially with regard to the possibility of pregnancy, so it is vital that the warnings about the harms of valproate are always brought to mind.'
She added: ‘We are pleased to provide guidance to support the further strengthening of safety warnings around dispensing and we ask all dispensers of medicines containing valproate to consult the new guidance carefully.’
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The regulation amendments – effective as of 11 October 2023 – currently apply in England, Scotland and Wales, although the government states that the MHRA guidance should also be regarded as 'good practice' by pharmacists in Northern Ireland.
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