Following a consultation, the Government has put in place amendments to the Human Medicines Regulations 2012 (HMRs) to:
- require manufacturer’s original full pack dispensing of valproate-containing medicines
- enable pharmacists to supply up to 10% more than or less than the amount on a prescription of medicines other than those containing valproate, so that they can dispense a manufacturer’s original full pack instead of splitting the pack, known as original pack dispensing (OPD).
Original Pack Dispensing for medicines (excluding those containing valproate)
New legislation means pharmacists will have the flexibility to dispense up to 10% more or less than the quantity prescribed if that means they can dispense in the manufacturer’s original pack.
The aim of original pack dispensing is to increase patient safety by ensuring the medicine is provided with the patient information leaflet (PIL), which contains information about the safe and effective use of the product. Additionally, it supports efficiencies in pharmacies as it reduces the need to spend time repackaging medicines.
The flexibility to dispense up to 10% more or less than the quantity prescribed will not apply to:
- Controlled Drugs
- Medicine in a form that makes it impracticable to dispense the exact quantity ordered
- Medicine in a container that has an integral means of application, or from which it is not practicable to dispense an exact quantity
- Medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine such as inhalers or where the packaging is keeping the medicine sterile.
Using your professional judgement
Using your professional judgement, one of the standards for pharmacy professionals, is a critical part of using the flexibility the new legislation allows.
You must always your professional judgement in the best interest of the patients. You may also wish to record the reasons for your decisions.
Pharmacists should use their professional judgement to ensure that the patient is able follow the medication regimen as intended by the prescriber. In some instances, that may mean not dispensing in an original pack.
Transition period
The flexibility to sell or supply an original pack containing a quantity of medicine up to 10% more or less than the quantity prescribed will not automatically apply to NHS prescriptions dispensed by community pharmacies in England and Wales unless the relevant NHS terms of service expressly apply the amendments to the Human Medicines Regulations 2012. This will allow England and Wales to decide how they want to apply this in their respective NHS services. In Scotland, the original pack dispensing 10% flexibility comes into force with immediate effect.
Original pack dispensing of valproate-containing medicines
From the 11 October 2023, new rules on dispensing valproate-containing medicines came into force which require manufacturer’s original full pack dispensing of valproate-containing medicines. This is to ensure that women always receive information about the harms of valproate during pregnancy.
Further information is available on the MHRA website. MHRA have also published guidance on full pack dispensing of valproate-containing medicines.
What you need to know
- Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
- Pharmacists must either round up or down so that the patient receives their supply in the manufacturer’s original full pack and ensure that they receive an amount that is as close as possible to that prescribed.
- Valproate-containing medicines must not subsequently be re-packaged into plain dispensing packaging.
Exceptional circumstances
The manufacturer’s original full pack does not have to be supplied where:
- a risk assessment is in place that refers to the need for the patient to be sold or supplied valproate-containing medicines in different packaging from its manufacturer’s original full outer packaging (for example, in a monitored dosage system) and
- assuming that the product is authorised, there are processes in place to make sure that the patient receives the Patient Information Leaflet. That is not the case for unauthorised medicines, unless they are only unauthorised as a result of an assembly process.
Information and resource to help you
We have gathered together all of our resources and information about valproate on one page on our website so it is easier for you to stay up-to-date.