Revised: 21 November 2023
Safety Information
Medsafe Safety Communications
What are Medsafe safety communications?
Monitoring communications
Alert communications
Medsafe communications issued in the last 12 months
Medsafe communications issued more than 12 months
ago
Further information
What are Medsafe safety communications?
These communications are intended to help consumers and healthcare professionals make informed decisions about their use of medicines and medical devices.
Medicines and medical devices provide important benefits for consumers but no product is completely safe. Whilst many risks are identified before the product is used in New Zealand some are identified later.
The known risks associated with medicines in New Zealand are outlined in the consumer medicine information (CMI) and the data sheet. The known risks for medical devices are generally outlined in the product information/user manual. Your healthcare professional can also provide help and assistance on how to use medicines or medical devices. Further information may be found on the product packaging or the company supplying the medicine or medical device may operate a helpline.
There are two types of Medsafe safety communications.
- Monitoring communications
- Alert communications
Anyone can subscribe to receive Medsafe safety communications.
How do I subscribe to receive Medsafe safety communications?
Monitoring Communications
These communications are intended to provide information to consumers and healthcare professionals about newly identified potential safety concerns.
In some cases, these communications are issued to request further information
from users. Safety concerns for medicines for which Medsafe is actively
seeking further reports display this symbol:
No actions are generally advised, other than to follow the instructions provided with the medicine or medical device. Consumers should NOT stop using a medicine or medical device following a monitoring communication. Healthcare professionals should not change a patient's treatment because of a monitoring communication.
Not all of these concerns will result in an action. This is because after an investigation, Medsafe may not consider that there is a link between the events and the medicine or medical device. Medsafe may reinvestigate the concern if more information is identified at a later date.
Alert Communications
Alert communications are issued once a review of the safety concern is complete. Alerts contain more information on the safety concern and provide specific advice on actions that may need to be taken by healthcare professionals and consumers.
Even though an alert has been issued it does not necessarily mean that a medicine or medical device is considered to be unsafe.
Safety concerns which identify defective medicines or medical devices supplied in the market may result in a recall action. This can include removal of the product from supply or undertaking corrective action. Recent recall actions initiated in New Zealand are published in the Medsafe Online Recalls Database (MORD).
Search the Medsafe Online Recall Database (MORD)
Medsafe Safety Communications Issued in the last 12 months
Medsafe safety communications issued more
than 12 months ago
Further Information
Further information on the development of the Medicines Monitoring scheme
and Medsafe's safety monitoring processes can be found in the following
links.
What is the Medicines Monitoring
scheme
?
How does Medsafe monitor medicine safety?
How does Medsafe monitor the safety and quality of medical devices?
Medsafe safety communications were initially developed as a joint project with the Australian Therapeutic Goods Administration (TGA) and called the trans-Tasman Early Warning System. Further information on this project can be found in the following links.
Consumer questions and answers on the early warning system
Healthcare professionals questions and answers on the early warning system
Audit of the first 12 months of the early warning system (PDF, 350KB, 14 pages)
Further information on the criteria used by Medsafe to decide when to publish a monitoring communication (PDF 224KB, 9 pages)
