Pharmacists will be allowed to dispense medicines according to the amount contained in the original pack, even if this is slightly different to the amount prescribed, the government has said.

And medicines containing sodium valproate must be dispensed as a whole, original pack, following concerns that splitting packs meant that patients did not have access to safety information and were unaware of the risks of the drug on pregnancy.

The amendments are the outcome of a consultation into original pack dispensing and the supply of medicines containing sodium valproate, which ran between 1 November and 13 December 2021.

Following the consultation, the government has announced its intention to amend the Human Medicines Regulations Act 2012 with the proposed changes.

It will then be up to the administrations in England, Wales, and Northern Ireland to decide how the changes will be implemented and applied in each nation.

Under the amendments, pharmacists and pharmacy staff under the supervision of pharmacists will be allowed to dispense up to 10% more or less of a medicine than prescribed if it means they can dispense it in the original pack – known as original pack dispensing (OPD).

This will be at the judgement of the responsible pharmacist – for instance, in some cases, like when supplying steroids or antibiotics, the pharmacist may decide that the exact quantity may be supplied in order for the patient to complete the full course of treatment.

This aims to increase patient safety, by ensuring that patients have access to the safety information, and also saves pharmacy staff time that they would otherwise have spent splitting boxes and repackaging medicines.

It also increases compatibility with automated dispensing, as split packs must currently be processed manually.

In the case of medicines containing sodium valproate, pharmacists will have to supply the whole pack in the original packaging, to ensure that the patient has access to safety information and is informed about the risks of taking the drug.

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) said that they would not ask prescribers to prescribe consistent quantities, such as in units of 28 days, as this would reduce clinical freedom and add an extra burden on GPs. Instead, pharmacists will have the flexibility to supply the nearest quantity of medicines (up or down) that can be made up of complete packs.

There will be an exception to the sodium valproate amendment on an individual patient basis, where there is a risk assessment in place that refers to the need for different packaging such as a monitored dosage system. If this happens, processes must be in place to ensure that the patient still has access to the patient information leaflet (PIL).

The changes to OPD will apply immediately in Scotland, but there will be a transitional period in England, Northern Ireland and Wales, to enable each administration to decide how it wants these changes to apply to the NHS in each nation, including how pharmacists will be reimbursed.

The amendments to sodium valproate dispensing will apply across the whole of the UK as soon as they are made.