All licensed medicines containing sodium valproate, valproic acid and semisodium valproate have been reclassified as special containers, meaning they are subject to full pack dispensing.
The change, effective since 1 October, means that where the prescription quantity is not available in an original pack size or multiple of pack sizes, the nearest number of full packs will be reimbursed – either rounded up or down, and rounded down when the quantity prescribed is exactly halfway.
Contractors do not need to endorse the prescription and they will automatically be paid for the relevant number of complete packs.
The new measure aligns with changes to the Human Medicines Regulations 2023, coming into effect on 11 October, that mandate full pack dispensing of all licensed medicines containing valproate.
The regulation changes follow recommendations made by the Independent Medicines and Medical Devices Safety Review, as well as the outcome of a recent public consultation on original pack dispensing and supply of medicines containing sodium valproate.
The measures have been introduced to help ensure that women and girls prescribed sodium valproate are informed about the risks of taking the medicine during pregnancy, since manufacturers’ original packs include specific warnings and pictograms on the labelling.
They also include a patient card, along with the statutory patient information leaflet (PIL), highlighting the risks of taking the medicine while pregnant.
Splitting packs meant that patients did not always have access to the safety information.
The General Pharmaceutical Council (GPhC) had previously raised concerns that women and girls prescribed sodium valproate were not always given sufficient guidance.
The GPhC cited instances of sodium valproate being dispensed by pharmacies in a white box with no safety warnings or PIL.
Despite the new rule, pharmacists will be able to make an exception based on an individual risk assessment to evaluate the patient’s need to be supplied the medicine in different packaging – for example in a monitored dosage system – and providing processes are in place to ensure a PIL is supplied.
The special container criteria outlined in Part II Clause 10B of the October 2023 Drug Tariff is to be updated according to the new rules.
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