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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 regulatory amendments proposed will enable pharmacists to dispense medicines in their original packaging for private prescriptions starting this Autumn, according to the Department of Health and Social Care. In the recently published draft OPD regulations, the DHSC has indicated that the alterations, permitting pharmacists to vary the dispensed quantity by up to 10 per cent to avoid splitting medicine packs, will be implemented for private prescriptions 'immediately upon the enforcement of the Human Medicines Amendment Regulations in the autumn,' as highlighted in a briefing by Community Pharmacy England. CPE stated that the regulations related to NHS prescriptions will come into effect when the pharmaceutical terms of service regulations expressly apply the OPD amendments. Moreover, new directive mandating the dispensing of sodium valproate products solely in their original packaging (except when an assessment of risk necessitates an alternative approach) will align with the rollout of the private prescription regulations during the autumn. CPE further noted that these regulations are currently in draft, indicating that they are not currently in effect and may undergo revisions prior to their implementation.

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.