Organisation objective

• Governance
• Statutory item

Executive summary

This paper is for the Board’s information only to provide an overview of the electronic Prescribing and Medicine Administration (ePMA) Directions 2024 (Directions) issued to NHS England (NHSE) in May 2024 by the Secretary of State for Health and Social Care (SoS). These Directions have been issued under section 254(1) and 304(9), (10) and (12) of the Health and Social Care Act 2012 (the 2012 Act) and sections 13ZC and 272(7) and (8) of the National Health Service Act 2006 (the 2006 Act) [see footnote 1]. 

The purpose of the Directions (Purpose) is to enable the collection and analysis of patient level medicines data from secondary care [see footnote 2] electronic Prescribing and Medicines Administration (ePMA) systems for medicines prescribed and administered to patients in England.

Action required

The Board is asked to note the new Directions and the information provided in this Paper regarding their purpose, effect, and requirements.

Background

1. Under section 254 of the 2012 Act, the SoS may direct NHSE to establish and operate a system for the collection or analysis of information. These are functions exercisable in relation to the development or operation of information systems in connection with the provision of health services or of adult social care in England. Under section 13ZC of the 2006 Act, the SoS may give NHSE directions as to the exercise of any of its functions. The Directions are issued by the SoS to NHSE under these provisions and are functions which have been transferred to NHSE from NHS Digital (NHSD) under the Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023.

Purpose of the Directions

2. The purposes of the Directions are to enable the collection and analysis of patient level medicines data from secondary care [see footnote 3] ePMA systems for medicines prescribed and administered to patients in England.

3. From December 2024 NHS England will collect medicine data every week from each secondary care provider (typically hospitals) in England who use an ePMA system to record the medicines they give to patients. We are also collecting data backdated to 1 June 2018 (or from the point ePMA systems first started to be used if after this date). This collection will initially be from each hospital’s main ePMA system which covers the majority of their wards. We may extend the collection to other ePMA systems used in hospitals for different specialities such as cancer, dialysis, intensive care, maternity, and ophthalmology.

4. The core purposes of this data collection established by the Directions are:

• to provide a comprehensive and comparable national patient level data set about medicines use in secondary care which can be used for for planning, commissioning and research purposes;
• to enable the monitoring of medicines utilisation, weighing the cost and benefits of using treatments in comparison with with others (pharmacoeconomics [see footnote 4]), and research into the safety and effectiveness of medicines, with the aim of supporting improvements in patient outcomes;
• to support the monitoring and the use of antimicrobials, which are therapeutic substances used to prevent or treat infections, in line with the UK Government’s strategy regarding the tackling of antimicrobial resistance [see footnote 5]
• to improve consistency of medicines recording in secondary care settings, NHS England will assess each provider’s data coding and will send data quality reports back to each hospital about how well they are following the NHS standard for recording medicines and devices used in their computer systems. This standard is called the dictionary of medicines and devices (dm+d). These reports will not identify any individuals

Data Sharing

5. From December 2024, NHS England will share data with organisations who have a lawful basis and need to access secondary care medicine data to support improvements to health outcomes and sharing will be dependant upon Data Sharing Agreements established via the NHS England Data Access Request Service.

6. Data will generally only be shared for analysis through the Data Access Request Service and, subject to limited exceptions, through Secure Data Environments, including the NHS England Secure Data Environment, in line with NHS policy on Secure Data Environments. Instances of analysing or disseminating data outside of a secure data environment will be extremely limited. Any exceptions will require significant justification, such as where explicit consent from clinical trial participants has been obtained.

Effect and Requirements of the Direction

7. From the date of signature of the Directions, NHSE will have a legal duty to comply with the Directions, which will require it:

• to establish and operate such systems for the collection and analysis of information as are necessary to meet the above Purpose of the Directions; and
• to analyse the information collected, including linkage to other data lawfully held by NHSE, as NHSE determines is necessary, to achieve the above Purpose

8. These functions are to be exercised in accordance with the Requirements Specification attached to the Directions (as they may be updated from time to time). Also in accordance with the service levels, support and monitoring requirements, and the reporting and governance requirements notified by the SoS in writing to NHSE. The exercise by NHSE of the functions set out in the Directions is also subject to the statutory guidance issued by the SoS to NHSE under section 274A of the 2012 Act: NHS England’s protection of patient data, 23 May 2023 [see footnote 6] which is guidance that NHSE has a duty to have regard to when discharging its functions under these Directions.

Approval of acceptance of Directions and publication

9. The National Director of Transformation and National Medical Director approved acceptance of the Directions on behalf of the Accounting Officer as set out in the NHSE Scheme of Delegation.  The Directions have been published on the NHSE website [see footnote 7].

Annex 1

Secondary Care electronic Prescribing and Medicines Administration (ePMA) Directions 2024

Secondary-care-epma-directions-requirements-specification-v1.0

Footnotes

1. S.I. 2013/259 as amended by S.I. 2023/98
2. Secondary care refers to hospital (acute, mental health) and community care services settings – using ePMA systems.
3. Secondary care refers to hospital (acute, mental health) and community care services settings – using ePMA systems.
4. Pharmacoeconomics is the branch of health economics that focuses on weighing the costs and benefits of a particular intervention in comparison with an analogous alternative. This type of analysis is critical given the goal of maximizing value for patients, healthcare payers and society in light of increasingly scarce resources
5. Tackling antimicrobial resistance 2019–2024 – The UK’s five-year national action plan
6. https://www.gov.uk/government/publications/nhs-englands-protection-of-patient-data/nhs-englands-protection-of-patient-data
7. Secondary Care electronic Prescribing and Medicines Administration (ePMA) Directions – NHS England Digital

Publication reference:  Public Board paper (BM/24/33a(Pu))