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Pharmacists may have to supply sodium valproate in original pack

The MHRA is planning to consult on introducing a legal requirement for pharmacists to supply sodium valproate in its original pack in a bid to support its safe use, the DH said.

UPDATE: On November 1, 2021 the Department of Health and Social Care (DH) launched a consultation on original pack dispensing (OPD) and the supply of medicines containing sodium valproate.

Among its proposals to amend the Human Medicine Regulations 2012, the DH suggested that the supply of sodium valproate “must always be in original packaging regardless of the conditions we set around OPD”.

The DH is also considering giving pharmacists “flexibility to dispense more or less than the prescribed quantity” of the medication, within a 10% margin, so they can issue the prescription in the manufacturer’s original packs. This measure would not apply to controlled drugs and in cases where it would “negatively affect the patient’s clinical treatment regimen”, it stressed.

The consultation will run until December 13.

The Department of Health and Social Care (DH) published its response to the Independent Medicines and Medical Devices Safety Review yesterday (July 21).

Former health minister Jeremy Hunt commissioned Baroness Julia Cumberlege to lead on the review in February 2018, asking her to “consider whether any further action is needed relating to the complaints around Primodos, sodium valproate and vaginal mesh”.

“Actions” on safe use of valproate


The review does not contain a “strategic recommendation” on the use of sodium valproate (valproate), the DH said in its response, but it offers a “number of actions” for improvement related to its use.

Among the changes being considered, the Medicines and Healthcare products Regulatory Agency (MHRA) is “planning to consult on an amendment to the Human Medicines Regulations, which would require pharmacists to supply sodium valproate in the manufacturer’s original pack”.

“This will ensure that prescriptions for valproate are dispensed with a patient information leaflet (PIL) and information on risk minimisation measures,” the DH added.

The MHRA has also been reconsidering the use of valproate to treat bipolar disorders. “Clinical advice is that there are effective alternative treatment options for acute mania that are safer to use during pregnancy,” the DH continued.

“With respect to epilepsy, the MHRA will consider further whether the indications for paediatric use of valproate could be better specified in the product information to ensure the initiation of girls on valproate only occurs when strictly necessary,” the DH added.

Considerations for pharmacy professionals


In June, NHS England and NHS Improvement issued a letter to all women and girls aged 12-55 who are currently prescribed sodium valproate, raising some safety considerations.

Two days later, the General Pharmaceutical Council (GPhC) sent a reminder to all pharmacy professionals on how to safely supply valproate to women and girls.

It said that pharmacists must ensure that “the patient label is not placed over the warning labels or warning sticker on the box”.

“Women taking valproate have shared with us examples of where this has happened,” the GPhC noted.

It also asked pharmacy teams to ensure a patient card is provided every time valproate is dispensed and that, if repackaged, valproate should have a warning on the container supplied, along with a copy of the PIL.

“Valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place,” the GPhC warned.

On January 7, the MHRA published findings from a review of the safety of antiepileptic drug use during pregnancy, concluding that lamotrigine and levetiracetam were overall the safer of the reviewed antiepileptic drugs for use by pregnant patients.

What advice can pharmacists give to pregnant patients with epilepsy? Refresh your knowledge with our CPD article.

Do you think pharmacists should supply valproate in its original packaging?

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