Changes to the Human Medicines Regulations 2023 came into effect today (11th October) which provides new rules requiring pharmacists to dispense all licensed medicines containing valproate in the manufacturer’s original full pack.
When dispensing valproate products, the pharmacist must supply the product as a complete pack. This will require them to round up or down the quantity prescribed to ensure the patient receives their medicine in the manufacturer’s original packaging. Valproate-containing medicines must not be repackaged in plain dispensing packaging.
Based on an individual risk assessment, which assesses the needs of patients, pharmacists can make exceptions to these rules and supply medicines containing valproate in different packaging (for example in a monitored dosage system), provided processes are in place to ensure a PIL is supplied.
For reimbursement purposes, all licensed medicines containing sodium valproate, valproic acid and semisodium valproate were reclassified as special containers from 1st October 2023. Where the quantity on a prescription is not for a quantity in original pack size or multiple pack sizes, the nearest number of full packs will be reimbursed (either rounded up or down; rounded down when the quantity prescribed is exactly halfway between rounding up or down). Pharmacy teams do not need to endorse the prescription, you will be automatically paid for the relevant number of complete packs.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today published new guidance for dispensers to support this change.
For more information including reimbursement and FAQs read our news article: All valproate-containing products reclassified as special containers from October 2023
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