Electronic Yellow Card Reporting
Defines a method for data submission about suspected adverse drug reactions via the Yellow Card Scheme by populating the majority of the Yellow Card submission from the patient's electronic record.
About this standard
- Publisher
- NHS England
- Reference code
- DCB1582 Amd 16/2017
- Publication date
- 26/10/2017
- Publication version
- 3.0.0
- Status
- Active
Show definitions of statuses
Active. Active standards are stable, maintained and have been approved, assured or endorsed for use by qualified bodies.
Deprecated Deprecated standards are available for use and are maintained, but are being phased out, so new functionality will not be added.
Retired standards Retired standards are not being maintained or supported and should not be used.
- Standard type
- Information standards
Show definitions of standard types
Collections. A Collection is a systematic gathering of a specified selection of data or information for a particular stated purpose from existing records held within health and care systems and electronic devices.
Extractions. An extraction is a type of collection that is pulled from an operational system by the data controller and transmitted to the receiver without additional processing or transcription by the sender.
Information standards. Information standards are agreed ways of doing something, written down as a set of precise criteria so they can be used as rules, guidelines, or definitions.
Technical Standards and specifications. Technical standards and specifications specify how to make information available technically including how the data is structured and transported.
- Contact point
Link to standard
- Documentation
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- Applies to
- General Practices MUST follow this standard
- Other NHS providers, for example: acute trusts, community trusts and pharmacies MAY follow this standard
- Impacts on
- Implementation of this information standard impacts all health IT systems suppliers providing Yellow Card functionality in systems to the above providers; suppliers should work with their customers to determine necessary changes. Note that as part of the requirements under the NHS GP Systems of Choice Programme (GPSoC), all suppliers of primary care systems must integrate electronic Yellow Card facilities into their clinical software.
- Conformance date
- 01/12/2018
- Effective from
- 01/02/2018
Topics and care settings
- Topic
- Data definitions and terminologies
- Care setting
- Community health
- GP / Primary care
- Hospital
- Pharmacy
Dependencies and related standards
- Related standards
- Dictionary of medicines and devices (dm+d) SCCI0052
- SNOMED CT SCCI0034
- ICH E2B (R2) Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.33)
- Dictionary of medicines and devices (dm+d)
Review Information
- Scope
- NHS Services
- Sponsor
John Quinn, Medicines and Healthcare products Regulatory Agency
- Senior Responsible Officer
Mick Foy, Medicines and Healthcare products Regulatory Agency
- Business Lead
- Rebecca Owen, Medicines and Healthcare products Regulatory Agency
- Contributor
- Medicines and Healthcare products Regulatory Agency
- Approval date
- 12/10/2017
- Post Implementation review Date
- 01/12/2019
Legal basis and endorsements
- Legal authority
Section 250 of the Health and Social Care Act 2012
This information standard is published under section 250 of the Health and Social Care Act 2012
More information
This standard aims to facilitate IT systems to reduce the burden on clinicians.
The Medicines and Healthcare products Regulatory Agency (MHRA) collects reports of suspected adverse drug reactions (ADRs) via the Yellow Card Scheme. These reports provide a source of information on potential drug safety issues allowing the Agency to take regulatory action to protect public health.
Reports can be submitted in a number of ways and this standard is designed to make it easier, and therefore less burdensome, for healthcare professionals to produce and send reports by enabling direct reporting from the clinical system.
Integration of direct Yellow Card reporting into clinical systems makes it easy to complete and send a Yellow Card because much of the information needed can be automatically populated from patient records. At the same time, electronic reporting provides a secure, fast, and convenient method for submitting information about suspected adverse drug reactions.
About this change
This release introduces minor wording changes to enhance user understanding of system requirements and conformance criteria. In addition, clarification is given in respect of XML message and field validations. This should provide more clarity for system suppliers and reduce the risk of transcribing and translational errors by healthcare professionals. The opportunity has also been taken to provide updated details about the mapping of (a) SNOMED CT to MedDRA terms and (b) dm+d to the MHRA drugs dictionary.Page last updated: 19 June 2024