Standard ISB 1582
|Title||Electronic Yellow Card Reporting|
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.
This standard 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 patients electronic record.
The information standard incorporates the ICH E2B(R2) international standard format for reporting adverse drug reactions.
NHS organisations including any healthcare professional which contribute to the MHRA Yellow Card Scheme and their IT suppliers. GP Practices and system suppliers SHOULD follow this standard. Other health organisations and system suppliers MAY follow this standard.
The standard excludes medical device incident reporting, reporting of adverse events or reactions to blood or blood components, defective medicine reporting, and reporting of medication errors where no harm occurs.
The standard is intended to be used in, but is not limited to:
GP Surgeries / Primary care.
Community, day hospitals, day services, out patient clinics.
The patients home or any other remote setting (depending on the specific NHS organisations infrastructure and technological capability).
The scope of the standard is NHS in England. However, the remit of the MHRA and Yellow Card Scheme is UK wide therefore Scotland, Wales and Northern Ireland will be asked to adopt this standard.
|Sponsor Organisation||Medicines and Healthcare products Regulatory Agency|
|Current Release||Amd 28/2012|
|Date Published||Release Number||Release Title||Stage||Link to Documentation|
|10-Sep-2012||Amd 28/2012||Minor Amendments||Implementation||Documentation|
|31-Jan-2012||Amd 24/2011||Initial Standard||Retirement||Documentation|