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Development History

1. Background

In early 2008 during the development of a version of MiDatabank suitable for the Pharmaceutical Industry, facilities were implemented to enable the recording of Adverse Drug Reactions (ADRs), and the subsequent transmission of this data in e2B format to the Pharmacovigilance (PV) department of a company.

It was realised that the user-interface for recording ADRs and transmission of this data to PV was almost identical to that required for the recording of ADRs by hospital pharmacists and the transfer of this data to the host nations regulatory authority. CoAcS subsequently adapted the existing option for ADR submission into the hospital version of MiDatabank.

In November 2008 the MiDatabank User Group met to discuss and prioritise the development of features for the hospital version of MiDatabank. An item from the minutes of the meeting states:

-  Adding in the ability to generate a Commission on Human Medicines (CHM) yellow card report on the back of an Adverse Event enquiry would be helpful and will be investigated.

Following this meeting a proposal was generated by Christine Randall at the North West Medicines Information Centre at Liverpool, a Yellow Card Centre, and sent to the MHRA.

Proposal to incorparate Yellow Card reporting into the MiDatabank system

The response from Mick Foy, the Pharmacovigilance Signal Management Group Manager was extremely positive and included a request for the MHRA to work with CoAcS to ‘develop a true electronic report that comes direct to the database’.

2. Development of ADR Reporting User Interface and Data Structure (MHRA and CoAcS)

In May 2009 Mick Foy and Paul Barrow from the MHRA met with Keith Brown and Steven Moss from CoAcS.

It was agreed that CoAcS and the MHRA would collaborate to progress the development of ADRs submission in MiDatabank. The first version was to be a manual submission by pharmacists using a PDF sent by email, followed by an electronic submission using data in e2B format.

The development of MiDatabank continued with the integration of MedDRA and a dedicated ADR user-interface designed by CoAcS, that collected and validated data in accordance with the requirements of the MHRA.

In October 2009, the same individuals met again at the MHRA Headquarters in London.  The design was finalised and approved by the MHRA, and the MHRA logos were subsequently integrated into the PDF Yellow Card Report generated by MiDatabank.

The first beta version of MiDatabank 3 was finished in November 2009. This included the ADR reporting facility

In December 2009, the MHRA and CoAcS were invited to attend a UKMI Executive Meeting, in order to gain approval of the ADR features for use in MI centres in the UK, and to determine the next steps and to plan for the pilot of the ADR submission facility within the UKMI network of centres.

3. Pilot of ADR PDF/Email Submission

In February 2010, Simon Wills of the Wessex Regional Centre in collaboration with Stephen Moss of CoAcS, were successful in obtaining funding from the MHRA to look at using MiDatabank to increase yellow card reporting. The project involves 5 hospitals reporting actual ADRs:-

MHRA/UKMi MiDatabank Yellow Cards Project. Lead Researcher: Sandra Hicks
(Reprint from PIPELINE Issue 31 December 2010 © Pharmaceutical Information and Pharmacovigilance Association)

Reprint from PIPELINE Issue 31 December 2010
© Copyright Pharmaceutical Information and Pharmacovigilance Association.
Reprint from PIPELINE Issue 31 December 2010
© Copyright Pharmaceutical Information and Pharmacovigilance Association.

In January 2011, Simon Wills (UKMI), Keith Brown (CoAcS) and Richard Backhouse (CoAcS) attended the Vigilance Priorities Board meeting at the MHRA, chaired by the MHRA Chairman Kent Woods. The interim findings of the project were presented. At the time of the meeting, a total of 49 Yellow Cards had been reported between 1st September and 30th November 2009.  An approximate statistical extrapolation of the interim findings indicates that this could result in a 50% increase in national Yellow Cards, if all UKMI centres were using MiDatabank ADR reporting.

Further extending the use of MiDatabank to clinical pharmacists, and to private hospitals in the UK could result in a further substantial increase of ADR reporting to the MHRA.

4. Pilot of ADR Electronic Submission

Following the success of the UKMI project involving submission of ADRs by email/pdf, MiDatabank version 3.1 was extended in order to provide electronic submission of ADRs to the MHRA using E2B format. This version has been piloted by 14 centres between February 2011 and September 2011. By the end of the September all 14 centres had successfully send an electronic Yellow Card (eYC)

5. National roll-out of eYC

In September 2011, the Chief Executive of the MHRA, Professor Sir Kent Woods, presented the eYC project to the annual UKMI conference. The targets set in the eYC pilot have been achieved, and the UKMI Executive has given approval for the national roll-out of the eYC using MiDatabank version 3.1, starting at the end of October 2011.