New Zealand’s Centre for Adverse Reactions Monitoring is now transitioning to a new digital system for collecting and storing adverse drug reaction reports in the country, retiring its almost 60-year-old database.

The centre has worked with medicines regulator Medsafe in developing the new digital database, whose early version went online in December last year to support the processing of ADRs for COVID-19 and monkeypox vaccines. 

Following their transition to the new digital system, CARM and Medsafe will be implementing a couple of changes to the processing of ADRs: 

  • Medsafe will now host the new database; it will also be responsible for the initial processing of ADRs.

  • CARM experts will now focus on conducting medical assessments of non-routine reports; it will continue responding to reports if an alert has been entered in the National Medical Warning System.

  • The reporting of adverse reactions to medicines remains “no-fault.”

Meanwhile, CARM and Medsafe are also preserving “valuable” information in the current database, which includes details of clinical studies conducted and information received from other organisations. CARM will hold historical data in the old database and will share this with Medsafe “as required.”

WHY IT MATTERS

CARM was founded in 1965, along with its systems and database. Given the ageing nature of the database, CARM and Medsafe thought it was time to move forward and develop a new digital database, said Medsafe group manager Chris James. This technology, he added, will allow them to improve the efficiency and effectiveness of their safety monitoring of medicines. 

“These changes will improve the turnaround time for processing 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. It also frees CARM of administrative overhead activities, allowing their physicians to focus on the valuable role of medically assessing non-routine reports,” Michael Tatley, director of the New Zealand Pharmacovigilance Centre at the University of Otago, further said about the changes in the processing of ADRs.

THE LARGER TREND

In other related news, researchers from South Korea have recently come up with an AI model to predict adverse reactions between prescription drugs and the oral anti-COVID-19 medication Paxlovid. The prediction model called DeepDDI2 was reportedly able to compute for and process a total of 113 drug-drug interaction types. 

The United Kingdom is also using AI to predict adverse reactions to COVID-19 vaccines. In 2020, it contracted Genpact UK to develop the said technology.

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