2023-10-01 18:33:48
On 9 July 2023, we reported the news that the Human Medicines Regulations would be amended (by the addition of regulation 217B) to allow pharmacists to supply a different quantity of a prescription only medicine to the quantity prescribed (subject to a variation of 10%), enabling manufacturer’s original packs to be supplied. The details of the amendment are in our news item of that date. The amendment will come into force on 11 October 2023 except that it will not apply to NHS prescriptions in England and Wales until their respective NHS terms of service permit this. The reason is to allow time to work out how much pharmacy owners should be reimbursed when a different quantity is supplied.
A new regulation 217C of the Human Medicines Regulations will also come into force on 11 October 2023, requiring valproate products to be supplied in manufacturers’ orginial packs. Valproate products pose a significant risk of birth defects when taken by women in pregnancy, and there have been reports that when these products have been dispensed for girls and women of childbearing age, they have sometimes been supplied in packs that are not the manufacturer’s original packs so do not display the warnings that appear on original packs, and without a patient information leaflet that also give clear warnings about the risks of taking valproate.