The Information Standards Board for Health and Social Care (ISB) closed on 31 March 2014.

Responsibility for the recommendation for approval of information standards has transferred to the Standardisation Committee for Care Information (SCCI). For further details visit the Health and Social Care Information Centre (HSCIC) website.

The approved information standards in the standards library on this website remain current and will continue to be updated, to mark items as superseded, on approval of changes by SCCI.

skip to content | Skip to navigation

In this section

 
You are here: Home Library All Standards ISB 1582

Standard ISB 1582

Number ISB 1582
Title Electronic Yellow Card Reporting
Description

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.

Applies To

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.

Pharmacies.

Acute hospitals.

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.

Status Approved
Sponsor Alison Davis
Sponsor Organisation Medicines and Healthcare products Regulatory Agency
Owner Public Health
Current Release Amd 28/2012

Releases

Date Published Release Number Release Title Stage Link to Documentation
10-Sep-2012 Amd 28/2012 Minor Amendments Maintenance Documentation
31-Jan-2012 Amd 24/2011 Initial Standard Retirement Documentation