NHSBSA Medicines Data Information System Specification

This specification sets out the requirements for the NHSBSA Medicine Data and should be read alongside the

• NHS Business Services Authority (NHSBSA) Medicines Data Directions 2019
• The NHS BSA Amendment Directions 2024

This specification:

• introduces the Medicines Data Programme;
• outlines the need to flow data about medicines dispensed or supplied, as held by NHS Business Services Authority (NHSBSA) into NHS Digital and the benefits expected; and
• describes how data will be collected, processed and disseminated

The NHS England Medicines Data programme has been commissioned to provide good quality medicines data and is crucial to the delivery of commitments laid out in the following;

• NHS Long Term Plan
• Next Steps on the Five Year Forward View
• Antimicrobial Resistance (AMR) Strategy
• Life Sciences Industrial Strategy
• World Health Organisation’s 2017 3rd global challenge, ‘Medication without Harm’

The purpose is to enable the collection and analysis of patient level medicines data, for medicines prescribed and dispensed or supplied to patients under services commissioned by NHS services, including such data held by the NHS Business Services Authority, to provide a comprehensive and comparable national patient level data set about medicines use for planning, commissioning and research purposes, for example;

• enable the monitoring of medicines utilisation, pharmacoeconomics, and research into the safety and effectiveness of medicines, including when linked with other datasets held by NHS England, with the aim of supporting improvements in patient outcomes; and
• support the monitoring and the use of medicines, including but not limited to, antimicrobials in line with the UK Government’s strategy regarding the tackling of antimicrobial resistance

The project will ensure the availability of a full set of data about medicines dispensed or supplied, as held by NHSBA. This data will be linked to other datasets to provide richer information and improve intelligence about medicines safety, effectiveness and outcomes.  It will be made available through the NHS Data Access Request (DARS) to a range of authorised organisations for secondary uses such as to inform and support prescribing behaviour, decision making and research. 

There is genuine and significant demand for this data from a range of organisations including NHS England, NHS Improvement, the National Institute for Health and Care Excellence, Clinical Commissioning Groups and Trusts, the Department of Health and Social Care, research bodies, charities and other health organisations.  These organisations are currently represented through a Medicines Data Advisory Group.    

As the data is not currently available it has been difficult for these organisations to identify the benefits they expect to realise by using it.  Quality benefits have been identified and are summarised below.  No monetised benefits have been identified at this stage. 

The existing Medicines Safety Dashboard which links limited dispensing and hospital episode data has identified monetised benefits as a result of de-prescribing of medication and avoided hospital stays.  It is reasonable to assume that the continued development of indicators will result in additional new monetised and qualitative benefits.

It is also expected that benefits will emerge in the following areas of work: 

• improved intelligence on the uptake of new innovative medicines
• support for pharmacovigilance (the collection, detection, assessment and monitoring) of medicine safety (serious and severe ADRs)
• linkage to future secondary care patient level medicines data to allow measurement of medicine use across patient journeys
• impact of admission on polypharmacy (the concurrent use of multiple medications by a patient) and re-admission
• improved intelligence around use of Sodium Valproate and other teratogenic medicines (which contain an agent that can disturb the development of the embryo or foetus) and maternity
• tracking patients and high-risk medicines post-discharge for example injectable anticoagulants which are used to reduce the ability of the blood to clot

NHS England will work to ensure emergent benefits are realised and recognised.  

To maximise benefit realisation, the project will promote usage of data through a multi-agency Medicines Data Advisory Group.  Data usage will be monitored through Clear Data Access Requests and the Data Access Request Service.  Benefits experts within the Medicines Data Programme will work with data users to understand and measure the benefits realised.

Expected benefits are summarised below:

Source

NHS Business Services Authority.

Category

Patient identifiable data (by NHS Number), refer to ‘Annex - dataset specification’ included in this document.

Frequency

Monthly.

The Department of Health and Social Care and NHSBSA were fully consulted about this data collection, as were prospective NHS England data users. It was not judged that consultation with representatives of those from whom the information will be collected, or others such as patient representative groups, was necessary due to it being a subset of data already collected by NHSBSA.

NHS England will consult with NHS BSA in relation to any changes to this Specification.

Legal basis for collection, analysis, publication and dissemination

Pursuant to sections 254(1) and 254(6) of the Act, NHS Digital is directed to establish and operate information systems for the collection and analysis of data about medicines dispensed or supplied from community settings, as currently held by NHSBSA, according to the NHSBSA Medicines Data Directions 2019

Collection

The data being collected is obtained from NHS Prescription Services (part of the NHSBSA).  It is an extract of information captured during processing to calculate remuneration and reimbursement payments to community dispensers.  The majority of the data is taken from paper FP10 prescription forms and Electronic Prescription Service messages and will, where available also include medicines issued directly to patients without a prescription under services commissioned by the NHS. For example, those medicines issued under the Pharmacy First and pharmacy contraception services.    

The data relates to medicines, which includes but is not limited to patient information, from the NHSBSA of all prescriptions issued by prescribers and dispensed or supplied in the community under services commissioned by the NHS. The majority of the data includes prescriptions for medicines that are dispensed or supplied by community pharmacies, appliance contractors and dispensing doctors and prescriptions submitted by prescribing doctors in England for medicines personally administered in England.  Included are prescriptions written in England and dispensed outside England, prescriptions written in Wales, Scotland, Northern Ireland and the Isle of Man but dispensed in England. Prescribers include, but not limited to GPs, hospital doctors, NHS dentists and non-medical prescribers for example nurse, pharmacists.

The collection will include data processed by NHSBSA since April 2015.  Patient level information will be included, as shown in the high level list of fields to be collected in Annex A.  Historic data held by NHSBSA since April 2015 will be included in the collection. A detailed list of the current data fields in the technical specification is available online on the data products page and will be updated as the extract expands within the spirit of the directions:

The following data is not collected by NHSBSA:

• items dispensed or supplied within secondary care;
• items on an issued prescription that has not been presented for dispensing;
• items on a prescription that has been presented for dispensing but not submitted to NHS Prescription Services by the dispenser.

Data will be collected monthly using MESH for secure data transfer, as illustrated in this diagram.  The data about medicines dispensed or supplied will become an Information Asset in NHS England (IAR0000747) and will be retained by NHS England in line with data retention policies.

The data will be made available within NHS England and also through NHS England’s Data Access Request Service (DARS) to, for example: ALBs, NHS providers and commissioners and the life sciences community, for analysis to build intelligence on the safety and effectiveness of medicines and the impact of medicine use on patient outcomes and experiences, including improvements to an existing medication safety dashboard. Analysis will support research and innovation and measure uptake as well as enhancing opportunities to link to other data sets to improve patient care. 

The medicines data can also be linked to other patient level data sets already held in NHS England to provide a better understanding of the likely outcomes of medicine use regarding benefits, effectiveness and risk.

Linked data will be used to:

• maintain and develop the current Medications Safety Dashboard
• enhance existing and develop new publications
• respond to requests for data and information

Other patient level data sets available for linkage with the medicines data include but are not limited to:

• Hospital Episode Statistics (linking prescribing data to hospital admissions), providing the opportunity to measure the impact of prescribing on hospital
• admissions (benefits and risks) including the further development of the existing Medications Safety Dashboard
• Maternity services dataset to provide a better understanding of the use and safety of medicines in pregnancy
• Mental health and psychological therapies data sets to provide an understanding of how medicines are used for patients with mental health conditions
• GP dataset (if/when available) to provide further information about why and when medicines are prescribed (indication/condition), monitoring of medicine use, length of treatment and outcomes
• corporate reference data to validate data and derive additional information not provided by NHSBSA

There are also opportunities to link this data to other data sets held by external bodies including Public Health England, Genomics England and other researchers.

Regular Dissemination/Sharing

There are no planned regular disseminations.

Data Access Request Service (DARS)

We treat the data we hold with great care. All data which is shared by NHS England is subject to robust rules relating to privacy, security and confidentiality and only the minimum amount of data necessary to achieve the relevant health and social care purpose will ever be shared. 

In most cases we share de-identified or anonymous data obtained for the purposes of the medications data.  We will only share personal data relating to patient level data about medicines dispensed or supplied where there is a lawful basis to do so. 

Requests for data will be managed through NHS England’s Data Access Request Service (DARS).  

Organisations are able to apply to the (DARS) and on approval, with the appropriate legal basis, have access to data obtained under the Direction. Any dissemination will be subject to the organisations applying to access the data having a lawful basis to process it, NHS England having a lawful basis to disclose it, successful applications being made to the NHS England Data Access Request Service (DARS) and the organisations entering into a data sharing agreement.

Data approved via the DARS agreements will be included in our Data Uses Registers.

Data about medicines dispensed or supplied can be accessed in the public domain at an aggregate level from the NHS BSA via their open data portal or official statistical publications.

Linked data publications and historic medicines publications prior to them being passed to the NHSBSA are available at Prescribing data.

The data are used to:

• analyse data in a more meaningful way;
• for analysis to build intelligence on the safety and effectiveness of medicines;
• and the impact of medicine use on patient outcomes and experiences.

Information will be published in line with England’s duty to publish under section 260(1) of the Health and Social Care Act 2012, unless it falls within section 260(2) of the Act. For the avoidance of doubt the following data is specifically excluded from publication:

• unique prescriber code
• Patient NHS Number

NHS England will use its existing systems and technology to deliver this collection.

Changes to this Specification will be managed by NHS England in conjunction with the Department of Health and Social Care to ensure such changes are aligned with the NHSBSA Medicine Data Directions 2019.

NHS England will also consult with NHS BSA with regard to any changes to the Specification