On 31 May 2006, the MHRA transferred its Yellow Card database from the Adverse Drug Reactions Online Information Tracking (ADROIT) system to the Sentinel database. 'Sentinel' is the name we have given the platform of IT systems focused on delivering the MHRA Information Management Strategy (IMS). The Sentinel Programme brings together new technologies and new database systems and new and improved ways of working. The intention underpinning all of these changes is to support the Agency in improving the quality and responsiveness of services provided to its stakeholders.
What does this mean for Yellow Cards?
From 31 May 2006, all Yellow Cards received by the MHRA, are being entered into the Sentinel system. All previous Yellow Cards have been transferred from the ADROIT database to Sentinel.
For the MHRA, the new system brings advantages in faster processing of the data and will facilitate monitoring the safety of medicines. The new system is also based on updated database technology and is more closely linked to other data in the Agency.
What does this mean for reporters to the Yellow Card Scheme?
All Yellow Card data will be captured electronically at one point. This will enable faster entry to the centralised report collections and thus, more rapid detection of possible drug safety issues. The MHRA will then contact you to acknowledge your report and may ask for further information if this is needed for evaluation of the report.
What happens with reports in areas where there is a Regional Monitoring Centre?
The Regional Monitoring Centres are now called Yellow Card Centres and their role focuses on follow-up of reports in their areas as this has been shown to improve follow-up rates. (Reporters may request follow up by MHRA if they would prefer this.)
The Yellow Card Centres will continue their valuable work in education, communication, and in promotion of adverse drug reaction reporting amongst local health professionals.
The five Regional Monitoring Centres are now called:
- Yellow Card Centre Northern and Yorkshire (formerly CSM Northern and Yorkshire)
- Yellow Card Centre West Midlands (formerly CSM West Midlands)
- Yellow Card Centre Mersey (formerly CSM Mersey)
- Yellow Card Centre Wales (formerly CSM Wales)
- Yellow Card Centre Scotland (formerly CSM Scotland)
You can find further information about the Yellow Card Scheme on the MHRA website at www.yellowcard.gov.uk.
To request further information about the Scheme, you can:
Telephone: The National Yellow Card Information Service 0800 731 6789 (manned during office hours only, answering machine at other times)
Write to: Pharmacovigilance Signal Management Group
Vigilance and Risk Management of Medicines
1 Nine Elms Lane
London SW8 5NQ
Editing, as I'd put Adroit is NOT called sentinel, instead of Adroit is NOW called sentinel... DOH.