Revised: 1 July 2014
Safety Information
Trans-Tasman Early Warning System
Consumer questions and answers
- What are safety concerns?
- My medicine or medical device is mentioned in a monitoring communication, what should I do?
- My medicine or medical device is mentioned in an alert communication, what should I do?
- How are safety concerns identified?
- What is Medsafe doing about these safety concerns?
- What actions can Medsafe take?
- Why is Medsafe publishing these safety concerns?
- What is an adverse event?
- What is a side effect?
- How can I find information on the known side effects of medicines and medical devices?
- How do I report a problem (adverse event)?
- What adverse events should I report?
- Where can I find information on reported adverse events?
- How does the early warning system communication differ from Medsafe recall communications?
- What medicines are included in the early warning system?
- What medical devices are included in the early warning system?
What are safety concerns?
A safety concern is any potential safety problem linked to a medicine or medical device (therapeutic product). Safety concerns include known safety problems, changes to known safety problems, new safety problems and coincidental events. At the time the safety concern is detected, Medsafe may not know if the concern is really caused by the medicine or medical device.
My medicine or medical device is mentioned in a monitoring communication, what should I do?
No actions are generally advised, other than to follow the instructions provided with the medicine or medical device. You should NOT stop using a medicine or medical device following a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional.
Monitoring communications highlight potential safety concerns identified by Medsafe and are intended to encourage further reporting and research to provide more information on these safety concerns.
If you have experienced one of these safety concerns please submit a report to the Centre for Adverse Reactions Monitoring (CARM). Your report will contribute to Medsafe and CARM's monitoring of these products.
Report a problem witha medicine or medical device
My medicine or medical device is mentioned in an alert communication, what should I do?
Medsafe advises all consumers to follow the advice provided in the alert communication. Consumers should NOT stop taking any medicine or stop using any medical device without first seeking the advice of their healthcare professional, unless this is advised in the alert communication.
Even though an alert has been issued, it does not necessarily mean that a medicine or medical device is considered to be unsafe.
How are safety concerns identified?
Medsafe uses many sources of information to identify safety concerns. These sources include adverse event notifications, published papers, information from sponsors, clinical studies, information from researchers, healthcare professionals, other regulatory authorities and government agencies.
What is Medsafe doing about these safety concerns?
Medsafe investigate safety concerns to determine if there is a link between the event and a medicine or medical device. Medsafe reviews the information available on the safety concern and also seeks advice from experts. These experts include the Medicines Adverse Reactions Committee for medicine safety concerns and the Australian Advisory Committee on the safety of Medical Devices for medical device safety concerns. Medsafe also works closely with other regulatory authorities.
If there is a demonstrated link between the medicine or medical device and the safety concern, Medsafe will consider the appropriate action(s) that need to be taken to improve the safe use of the medicine or medical device.
What actions can Medsafe take?
As a regulator, Medsafe has to consider the balance between the benefits offered by any medicine or medical device and the potential risks associated with its use for the population as a whole (or individual patient groups where the risks may be higher) before it makes a decision on the appropriate response. There are a range of actions that can follow when a potential safety concern is identified. These include:
- informing healthcare professionals and consumers through alerts and other communications such as articles in Prescriber Update
- requiring changes be made to the data sheet for medicines
- changing the conditions of use or narrowing the population in which it can be used
- change the legal status of a medicine, (eg, make a medicine only available with a doctor’s prescription)
- requesting the sponsor to complete a study to investigate the concern
- withdrawing or suspending the market approval for the medicine
- removal of a medical device from the market
- recalling the medicine or medical device.
In some cases, no action may also be recommended and Medsafe will continue to monitor the safety concern.
Why is Medsafe publishing these safety concerns?
The early warning system is designed to support better health outcomes by providing improved access to information on safety concerns. It is part of the work we do to monitor the safety of medicines and medical devices for consumers. The early warning system is part of Medsafe’s proactive approach to monitoring the safety of medicines and medical devices.
As demand for information about medicines and medical devices grows, publishing safety concerns online by a reputable government agency improves public access to this important information. Medsafe is committed to improving transparency to build trust and confidence in our work.
Further information on the criteria used by Medsafe to decide when to publish a monitoring communication (pdf 224KB, 9 pages).
What is an adverse event?
Adverse events are unwanted and sometimes harmful outcomes when taking a medicine or using a medical device. An adverse event does not mean that the medicine or medical device was the cause of the event. Adverse events include side effects (adverse effects)
What is a side effect?
Side effects are known unintended effects of a medicine or medical device.
How can I find information on the known side effects of medicines and medical devices?
Consumer medicine information (CMI) is available for some medicines. In New Zealand the CMI is provided on a voluntary basis by the sponsor. If no CMI is available, a data sheet for all prescription and pharmacist only medicines is published on the Medsafe website. Data sheets are designed for healthcare professionals. If you have problems understanding a data sheet, or need further information, your doctor, pharmacist or nurse can help you.
The instructions for use, or user manual for your medical device, is a useful source of information.
The product packaging may have additional information or the company supplying the medicine or medical device may operate a helpline.
How do I report a problem (adverse event)?
Medsafe relies on the public, healthcare professionals and industry to report safety problems with medical devices and medicines (through the Centre for Adverse Reactions Monitoring (CARM)) - this allows us to identify and respond to safety concerns.
If you are experiencing an adverse event or think you may be experiencing one, please seek advice from your healthcare professional as soon as possible. The adverse event should then be reported.
What adverse events should I report?
Please report any suspected adverse event. You don’t need to be certain that a medicine or medical device caused the event. You can report events even if you think they might already be known about. You can report events to all medicines including those bought in a supermarket or other retail outlet. All reports help Medsafe to investigate the safety of medicines and medical devices.
Where can I find information on adverse events reported in New Zealand?
The Suspected Medicines Adverse Reactions Search (SMARS) allows you to search information from adverse event reports that Medsafe has received (through the Centre for Adverse Reactions Monitoring) in relation to medicines used in New Zealand from 1 January 2000.
Medsafe and the Therapeutic Goods Administration (TGA) also publish summaries of medicine adverse events reported in Australia and New Zealand from 01 January 2000 in the Joint Adverse Event Notifications System (JAENS).
View the Suspected Medicines Adverse Reactions Search
How does the early warning system alert differ from Medsafe recall communications?
The early warning system alert advises consumers, healthcare professionals and industry about new safety information on medicines and medical devices following the outcome of an investigation. An alert does not necessarily mean that a product is considered to be unsafe.
A recall communication provides advice to consumers, healthcare professionals and industry about a defective medicine or medical device. Recall actions undertaken in the New Zealand market are usually due to unacceptable quality, safety, efficacy /performance or presentation.
A summary of recent recall actions initiated in New Zealand can be viewed in the publicly accessible and searchable database: Medsafe Online Recalls Database (MORD).
Further information on recalls
View the Medsafe online Recalls Database
What medicines are included in the early warning system?
All medicines approved for use in New Zealand are included. Information may be published about medicines and vaccines obtained by prescription or from a pharmacist as well as medicines purchased from a pharmacy, supermarket or other outlet. Alerts communications may be also issued for funded unapproved medicines.
What medical devices are included in the early warning system?
All medical devices used in New Zealand are included.
Further information on the definition of medical device in New Zealand.
