Electronic Yellow Card Reporting
Summary
- General Practices MUST follow this standard
- Other NHS providers, for example: acute trusts, community trusts and pharmacies MAY follow this standard
- Community health
- GP / Primary care
- Hospital
- Pharmacy
Documentation
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.