Revised: 27 June 2019
Safety Information
Medicines
Monitoring
What is
?
How do I submit a report for a possible safety issue
listed on
?
What happens next?
Archived list of medicines
previously on
2011-2015
Outcome of medicines
previously on
2011-2015
What is ?
The scheme has been incorporated into Medsafe’s safety communications since 2016.
Monitoring communication safety concerns displaying the logo:
- highlight safety concerns identified from various sources, including suspected adverse medicine reactions reports sent to the Centre for Adverse Reactions Monitoring (CARM)
- encourage further reports to CARM and increase the information on these potential safety signals.
The scheme helps Medsafe and CARM to investigate these safety concerns and decide if any action needs to be taken. Safety concerns may be based on groups of reports to CARM or a single well-documented case.
The appearance of a possible safety issue to a medicine does not mean that Medsafe and CARM have concluded that this medicine causes the reaction.
Healthcare professionals do not need to stop prescribing these medicines. Please report any potential cases to CARM.
Patients with any concerns about medicines they are taking should talk to their doctor.
More information on Medsafe safety communications.
How do I submit a report for a possible safety issue listed on ?
Please send your report to CARM as for any suspected adverse reaction. This can be done even if the reaction happened some time ago. Please include as much information as possible as this helps the medical assessors at CARM to investigate whether the medicine caused the reaction.
Please continue to report all suspected reactions to all medicines to CARM. This helps us to identify new potential safety issues for further monitoring in this scheme.
Report a suspected adverse reaction to CARM.
What happens next?
Once you have submitted a report to CARM you will receive a reply thanking you for your report and providing you with some general information about the medicine and the reaction.
Safety concerns remain on for six months, but this may vary depending on the medicine and reaction.
Once the active monitoring period for a potential safety signal has ended Medsafe and CARM evaluate the signal and decide what actions, if any, need to be taken.
More information on how Medsafe investigates potential safety concerns.