In response to The Department of Health and Social Care’s and Medicines and Healthcare products Regulatory Agency’s public consultation on original pack dispensing and supply of medicines containing sodium valproate, the UK Government has confirmed it will make legislative changes to the Human Medicines Regulations (HMRs) giving pharmacists the flexibility to supply more or less of a medication than has been prescribed in order to dispense the medicine in its original pack.
The changes were announced on 19th March 2023 and will allow pharmacists to dispense up to 10 per cent more or less than has been prescribed in order to dispense medicines in the manufacturer’s original packs, “except where this would negatively affect the patient’s clinical treatment regimen”.
Original pack dispensing will not apply to controlled drugs.
The Government will also amend the HMRs to explicitly state that sodium valproate medicines must be dispensed “in whole packs to the nearest quantity prescribed (rounding either up or down)”. Pharmacists will be allowed to make exceptions to the whole-pack dispensing rules around sodium valproate “on an individual patient basis” if a risk assessment has been made that states the medicines should be supplied via alternative means such as an MDS tray, provided there are processes in place to ensure patients receive the PIL.
The policy intention is for both original pack dispensing and supply of complete packs of sodium valproate to apply to dispensing doctors. This does not need additional amendments to the HMRs. However, as with community pharmacies, to enable original pack dispensing will require an amendment to their NHS pharmaceutical terms of service.
Full details of the outcome of the public consultation are available on the GOV.UK website: https://www.gov.uk/government/consultations/original-pack-dispensing-and-supply-of-medicines-containing-sodium-valproate/original-pack-dispensing-and-supply-of-medicines-containing-sodium-valproate
