Consultation outcome

Original pack dispensing and supply of medicines containing sodium valproate

From:: Department of Health and Social Care and Medicines and Healthcare products Regulatory Agency
Published: 1 November 2021
Last updated: 19 March 2023 — See all updates

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Original pack dispensing and medicines containing sodium valproate: consultation response

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Detail of outcome

The Department of Health and Social Care’s and Medicines and Healthcare products Regulatory Agency’s consultation on original pack dispensing and supply of medicines containing sodium valproate ran for a period of 6 weeks from 1 November to 13 December 2021.

Note: this policy has subsequently been renamed to ‘original pack dispensing and whole-pack dispensing of medicines containing sodium valproate’ to better reflect the proposed amendments to the Human Medicines Regulations 2012.

This document provides the government’s official answer to the more than 80 responses received from a wide range of stakeholders across the UK. We would like to thank the respondents whose contributions – in the form of responses, support and expertise – have helped to develop this policy.

There was significant support from respondents who felt the proposal for original pack dispensing would increase patient safety and efficiencies would be gained. Furthermore, there was overwhelming support for the introduction of whole-pack dispensing of medicines containing sodium valproate, as it was seen as a beneficial risk minimisation measure by providing additional patient safety.

However, on the basis of responses to the consultation around the impact to vulnerable patients, the government intends to include an exemption to whole-pack dispensing of medicines containing sodium valproate, on an individual patient basis, where:

a risk assessment is in place that refers to the need for different packaging
processes are in place to ensure the supply of patient information leaflets

The consultation response discusses our analysis and the intention to make amendments to the regulations. We have broadly outlined how the legislation could be progressed in the interests of supporting patient safety as swiftly as possible.

Detail of feedback received

A summary of public feedback received is included as part of the final consultation response.

Original consultation

Consultation description

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.

How to respond

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.

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