Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) collects reports of suspected adverse drug reactions (ADRs) via the Yellow Card Scheme. These provide a source of information on potential drug safety issues allowing the agency to take regulatory action to protect public health. Healthcare professionals report ADRs either by completing a paper form or a form on an external website/App.
The Information Standard Notice (ISN) for Electronic Yellow Card reporting defines a method for submitting the information electronically; this allows IT systems to reduce the burden on the clinician by populating the majority of the Yellow Card submission from the patient's electronic record.
Requirements
ID | Requirement | Level |
|---|---|---|
EYCR-001 | Implement and maintain Electronic Yellow Card reporting inline with DCB1582: Electronic Yellow Card Reporting. | MUST |
Compliance, Assurance & Testing
To achieve Electronic Yellow Care Reporting compliance, suppliers work closely with the programme to create and deploy test script scenarios to test whether the functionality has been implemented appropriately. The testing section within the requirements specification elaborates further on this.
For advice, access to testing resources, and support contact pharmacovigilance@mhra.gov.uk team.
Dependencies
There may be dependencies for implementing this Standard, however, there are no Interoperability Standards within the Capabilities and Standards model that are dependents.Roadmap
Items on the Roadmap which impact or relate to this Standard |
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