Pharmacists are now legally required to dispense all medicines containing sodium valproate in the original manufacturer’s packaging, rounding up or down to the nearest quantity prescribed, the government has announced.
The move will prevent the drug being dispensed in unlabelled white boxes, without the statutory patient information leaflet (PIL) and associated warnings, helping to address concerns that some women remain unaware of the significant risks posed to their unborn baby should they fall pregnant while taking sodium valproate.
The change follows an “overall positive response” to the government’s proposals to make legislative amendments to the Human Medicines Regulations (HMR) 2012 around original pack dispensing of sodium valproate, the consultation for which ran between 1 November 2021 and 13 December 2021.
Currently, pharmacy staff are required to split medicine packs to dispense prescribed quantities where a prescription is not equal to a pack size.
In the case of valproate, if a GP prescribes multiples of 28 tablets for sodium valproate, while standard pack sizes are 30, 100 and 112 tablets, legislation states that pharmacists have to split the pack and use a plain white box. This means the medicine may be supplied in the absence of the PIL and warnings about pregnancy that come with the original packaging.
In November 2021, the government proposed two amendments to the HMR. First, to enable pharmacists, and pharmacy staff under the supervision of pharmacists, the flexibility to dispense up to 10% more or less of a medicine, compared with the quantity prescribed, if it means they can dispense it in the original pack. This will be introduced, but will not apply to controlled drugs.
Second, it proposed that medicines containing sodium valproate should always be dispensed to the nearest whole pack, by rounding the prescription either up or down.
Pharmacists will be able to make an exception to whole-pack dispensing of medicines containing sodium valproate on an individual patient basis, where a risk assessment is in place that refers to the need for different packaging, such as a monitored dosage system.
In its publication of the consultation outcome, published on 19 March 2023, the government said that 85% of respondents to the consultation either ‘agreed’ or ‘strongly agreed’ that whole-pack dispensing of medicines containing sodium valproate in the manufacturer’s original pack would ensure patients always received the safety information supplied on the label and in the PIL. Only 4% of respondents ‘disagreed’ or ‘strongly disagreed’.
In February 2023, at the launch of her report on her first 100 days in post, Henrietta Hughes, patient safety commissioner for England, pledged to work with partners across healthcare to “eliminate” dispensing of sodium valproate in unlabelled white boxes without warnings about pregnancy.
Commenting on the government’s response, Hughes said she welcomed the response to the consultation as it would help to “keep patients safe” and “release time to care”.
“I’ve listened to patients and amplified their voices into the heart of government, and I’m glad that they are now being heard,” she said.
“Patients have been campaigning for sodium valproate to be dispensed in original packaging for ten years, so I now urge the government to prioritise parliamentary time so it can be quickly implemented in law.”
Wing Tang, head of professional standards at the Royal Pharmaceutical Society, said enabling dispensing of valproate via the original pack would “improve patient safety”.
“We have called for the best use of the clinical expertise and professionalism of pharmacists to help manage the continuity of care for people prescribed any medicine, including valproate,” he added.
“We believe pharmacists should be empowered to make minor amendments without a protocol that enable different quantities to be supplied within 10% of the original prescription.
“We look forward to the implementation of the proposals.”
The government said that a “transitional provision” would be included so the flexibility to dispense up to 10% more or less of a medicine would not automatically apply in NHS pharmaceutical services in England, Northern Ireland and Wales, to enable these administrations to decide how they want these to apply in their respective NHS services, but will come into immediate effect in Scotland.
Whole-pack dispensing of medicines containing sodium valproate, however, will apply in all administrations as soon as the amendment to the HMR comes “into force”, it added.
However, the government said that administrations would need to consider how they will reimburse community pharmacies and dispensing doctors for the supply of whole packs of medicines containing sodium valproate.