Original pack dispensing and supply of medicines containing sodium valproate

The Human Medicines Regulations 2012 sets out the situations and requirements for pharmacists selling or supplying prescription-only medicines. This consultation seeks views and comments on proposals to update the requirements in legislation to enable original pack dispensing (OPD) for pharmacists and to introduce requirements to ensure medicines that contain sodium valproate are always dispensed in the original manufacturer’s packaging.

The aims of the proposals behind enabling OPD and whole-pack dispensing of medicines containing sodium valproate, are to support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer’s packaging about the safe and effective use of a product. A further aim, for OPD, as part of England’s Community Pharmacy Contractual Framework 5-year deal, is to support efficiencies for pharmacies – this will free up pharmacists and their teams for other tasks such as providing clinical services to patients.

This consultation document is intended to provide members of the public with information about the proposed changes and an opportunity to comment. This consultation is being made available in England, Wales, Northern Ireland and Scotland and the proposed changes to the legislation would apply throughout the United Kingdom. One of the purposes of this consultation is to set out the circumstances in which a pharmacist may deviate from the quantity of medicine prescribed in order to provide patients with the manufacturer’s original pack including the patient information leaflet.

We are also consulting on the new requirement that will be placed on pharmacists to always supply medicines containing sodium valproate in the manufacturer’s original pack, and that subsequently the statutory information and associated risk minimisation materials are always provided to the patient.

Responses will be accepted via the survey over a course of 6 weeks from 1 November 2021. The consultation will close on 13 December 2021.

Responses to this consultation will be carefully considered and reviewed, and will feed into decisions that are made when considering drafting of secondary legislation and finalising any proposals.