Published: December 2012

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What Happens to your Adverse Reaction Reports?

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Prescriber Update 33(4): 35–36
December 2012

Healthcare professionals are advised that the routine sharing of adverse reaction report details between the Centre for Adverse Reactions Monitoring (CARM) and Medsafe started on 1 November 2012.

Pharmacovigilance in New Zealand is jointly conducted by CARM and Medsafe. In September this year, CARM and Medsafe wrote to stakeholders in New Zealand to inform them of this minor change¹. This change does not impact on the confidentiality and privacy of information included in adverse reaction reports.

Sharing of all report details between CARM and Medsafe has previously been on an ad hoc basis. However, as of 1 November 2012 this sharing of reports is now routine. Access to full report details is consistent with international practices as pharmacovigilance centres are usually situated within the Medicines Regulator.

CARM and Medsafe have concluded that routine sharing of all report details will further facilitate the monitoring of medicines and patient safety. This change will help CARM and Medsafe to identify medicines related safety issues in New Zealand and provide information to healthcare professionals in a more timely fashion.

CARM will continue to anonymise reports where possible. However, CARM and Medsafe emphasise that all details contained within reports remain confidential. There will be no change to the 'no blame' reporting of adverse reactions in New Zealand.

There are no changes to how to report adverse reactions in New Zealand. Healthcare professionals are encouraged to continue to report all suspected adverse reactions to CARM in the usual way. Further information about how to report adverse reactions is available on the CARM and Medsafe websites https://nzphvc.otago.ac.nz/report/ and www.medsafe.govt.nz.

CARM and Medsafe would like to thank healthcare professionals for their diligence in reporting adverse reactions and thereby contributing to pharmacovigilance in New Zealand.

References

1. The Centre for Adverse Reactions Monitoring and Medsafe. 2012. Announcement of processing adverse reaction reports received in New Zealand September 2012. URL: www.medsafe.govt.nz/profs/adverse/AnnounceProcessADRinNZ.pdf (accessed 28 November 2012).