Friday, May 24, 2024

New adverse reactions database to modernise safety monitoring

The Ministry of Health today announced work has been completed on a new state-of-the-art digital database to record details of all adverse reactions to medicines reported to the Centre for Adverse Reactions Monitoring (CARM).

The new database will be jointly run by CARM and Medsafe.

“This new digital technology presents the opportunity to transform our existing processes and improve the efficiency and effectiveness of medicine safety monitoring,” said Group Manager of Medsafe, Chris James.

The safety monitoring of the effects of medicines will continue to be conducted jointly by CARM and Medsafe.

“The CARM database has been foundational to the work of CARM and Medsafe, and in recognising the opportunity presented by technology advances and the aging nature of the CARM system, we have worked together with CARM to develop a new state of the art digital solution,” said Mr James.

Manager of Medsafe, Chris James.

With work now complete on the full database, Medsafe and CARM are preparing to transition the collection and storage of CARM reports to the new Medsafe database and retire the CARM system.

“These changes will improve the turnaround time for processing adverse reaction reports (ADRs) so that staff at Medsafe and CARM will be able to focus more time on analysing reports, which will contribute to improved signal detection and overall safety monitoring,” said the University of Otago’s Director of the New Zealand Pharmacovigilance Centre, Michael Tatley.

“It also frees CARM of administrative overhead activities, allowing their physicians to focus on the valuable role of medically assessing non-routine reports.”

An early version of the new system came online in December last year to support the processing of ADRs for COVID-19 and Mpox vaccines.

The system worked well for staff and since then, work has been ongoing to build and improve upon it, the Ministry said today.

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