Original Pack Dispensing
Published on: 17th November 2023 | Updated on: 17th November 2023
Regulations on Original Pack Dispensing (OPD) and a requirement for sodium valproate and related products to be supplied in their original outer packaging (OP), subject to one exception, have been published. These are explained in our briefing.
Please note: OPD can only be utilised for private prescriptions until there have been changes made to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations.
Original Pack Dispensing
The regulations on OPD provide that a different quantity of the prescription-only medicine (POM) than that ordered on the prescription may be sold or supplied where:
- The quantity is no more than 10%, and no less than 10% of the prescribed quantity; and
- This enables the medicine to be dispensed in its original outer packaging, and
- The sale or supply is otherwise in accordance with the prescription.
As an example, a 30-tablet OP medicine may be dispensed against a prescription for 28, and a 28-tablet OP medicine may be dispensed against a prescription for 30.
Please note: this is a change to the Human Medicines Regulations and pharmacies can use original pack dispensing for private prescriptions. As yet, there have been no changes to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations, therefore original pack dispensing cannot be used for NHS prescritptions.
Changes to the Human Medicines Regulations 2023 came into effect on 11th October 2023 which provides new rules requiring pharmacists to dispense all licensed medicines containing valproate in the manufacturer’s original full pack.
When dispensing valproate products, the pharmacist must supply the product as a complete pack. This will require them to round up or down the quantity prescribed to ensure the patient receives their medicine in the manufacturer’s original packaging. Valproate-containing medicines must not be repackaged in plain dispensing packaging.
Based on an individual risk assessment, which assesses the needs of patients, pharmacists can make exceptions to these rules and supply medicines containing valproate in different packaging (for example in a monitored dosage system), provided processes are in place to ensure a PIL is supplied.
For reimbursement purposes, all licensed medicines containing sodium valproate, valproic acid and semisodium valproate were reclassified as special containers from 1st October 2023. Where the quantity on a prescription is not for a quantity in original pack size or multiple pack sizes, the nearest number of full packs will be reimbursed (either rounded up or down; rounded down when the quantity prescribed is exactly halfway between rounding up or down). Pharmacy teams do not need to endorse the prescription, you will be automatically paid for the relevant number of complete packs.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published new guidance for dispensers to support this change.
Q. Why have all sodium valproate-containing products been reclassified as complete pack special containers?
A. Whole-pack dispensing of medicines containing valproate has been introduced to support the Pregnancy Prevention Programme (PPP) and further decrease the number of babies who are born with serious complications. Sodium valproate a commonly used anti-epileptic (and in some cases the only effective treatment for some patients) is known to be associated with birth defects and neurodevelopmental disorders in children where sodium valproate is taken during pregnancy. To minimise the risk of unborn babies being exposed to the effects of this medication the PPP was introduced in 2018. This further measure of whole-pack dispensing has been introduced to ensure that those taking sodium valproate have access to information setting out the risks and need for a woman or girl of child-bearing potential to have a PPP in place before taking sodium valproate. This is because the manufacturer’s original packs include specific warnings and pictograms on the labelling, including a patient card, along with the statutory patient information leaflet (PIL), which highlights the risks of taking the medicine while pregnant.
Q. Can I dispense the exact prescribed quantity if this is different to the special container pack size?
A. Where the quantity ordered does not coincide with that of the special container pack size you are required to supply the nearest complete pack size. For example, where a prescription requests Sodium valproate 300mg modified-release tablets x 28 tablets, you should dispense the nearest complete pack size of 30 tablets. The pharmacy would be reimbursed accordingly as the complete pack of 30 will be treated as a special container by the NHSBSA.
For more information including reimbursement and FAQs read our news article: All valproate-containing products reclassified as special containers from October 2023