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The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription. The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the unborn baby if valproate-containing medicines are used in pregnancy. The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained in the manufacturer's original full pack. Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.

The Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.

Pharmaceutical Services Negotiating Committee (PSNC) has expressed its support for alterations in the Human Medicines Regulations 2012 to enable original pack dispensing (OPD) and supply of medicines containing sodium valproate by pharmacists. PSNC's support for changes was in response to the consultation on OPD, initiated by the Department of Health and Social Care (DHSC). The consultation had proposed regulatory changes to allow pharmacists to dispense (up to 10 per cent) more or less than the prescribed quantity of a given medicine in the manufacturer's original packs. Key aims of the proposal are to "support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer's packaging about the safe and effective use of a product," DHSC said.