Revised: 1 July 2014
Safety Information
Trans-Tasman Early Warning System
Healthcare professional questions and answers
- What are safety concerns?
- What actions do I need to take when a medicine or medical device is mentioned in a monitoring communication?
- What actions do I need to take when a medicine or medical device is mentioned in an alert communication?
- How does Medsafe identify safety concerns?
- How does Medsafe investigate safety concerns?
- What actions can Medsafe take in response to a safety concern?
- Does Medsafe regulate 'off label' use?
- Why is Medsafe publishing these safety concerns?
- How does Medsafe decide to publish a monitoring communication or an alert communication?
- What is an adverse event?
- What is a side effect?
- How can I find more information?
- What is the difference between absolute risk and relative risk?
- 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 associated with 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.
What actions do I need to take when a medicine or medical device is mentioned in a monitoring communication?
Patients should not have their treatment changed because of a monitoring communication.
Monitoring communications highlight potential safety concerns identified, but not yet fully investigated by Medsafe and are intended to encourage further reporting and research to provide more information on these safety concerns.
If one of your patients experiences one of these safety concerns please submit a report to the Centre for Adverse Reactions Monitoring (CARM). Your report will contribute to Medsafe and CARMs monitoring of these products.
What actions do I need to take when a medicine or medical device is mentioned in an alert communication?
Medsafe provides advice for healthcare professionals in alert communications based on its investigation findings. Of course the advice provided does not take into account additional individual factors such as previous treatment, disease severity, alternative treatment options and patient preferences. It is not mandatory to follow this advice as Medsafe does not regulate healthcare professionals. Please consider this information as you would all clinical practice advice.
Even though an alert has been issued, it does not necessarily mean that a medicine or medical device is considered to be unsafe. As always, the balance of benefits and risks of a medicine or medical device should be discussed with the patient before starting or continuing treatment.
How does Medsafe identify safety concerns?
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.
How does Medsafe investigate safety concerns?
Medsafe investigates safety concerns to determine if there is a link (often called a causal association) between the event and a medicine or medical device. Medsafe identifies all the possible information available on the safety concern and reviews this information. Medsafe 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 in response to a safety concern?
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 through articles in Prescriber Update and other communications
- 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.
Does Medsafe regulate 'off label' use?
The term 'off label' refers to use of a medicine outside the specified indications or intended purpose for example:
- for an indication or intended use not mentioned in the data sheet or the package label
- in a different population to that intended (eg, children or pregnant women)
- at a different dose to that recommended
- via a different route of administration
If the recommended use of a medicine changes with the result that a patient is now taking the medicine 'off label' the patient should be informed. The patient and prescriber will need to make a joint decision on treatment options. In New Zealand there is no legal barrier to 'off label' medicine use providing that the Code of Health and Disability Services Consumers’ Rights 1996 is followed.
More information on the use of unapproved medicines and unapproved uses of medicines
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 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.
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 more information?
Data sheets for prescription and pharmacist only medicines are published on the Medsafe website. Data sheets provide information on the known effects of a medicine. Further information can be obtained from the New Zealand Formulary. The known risks for other types of medicines are generally outlined on the package labelling.
The instructions for use, or user manual for medical devices, are a useful source of information.
The company supplying the medicine or medical device may operate a helpline.
What is the difference between absolute risk and relative risk?
Absolute and relative risk are two different methods of explaining risk and can be used to describe the likelihood of a negative outcome to a therapeutic treatment.
Absolute risk is the risk of developing a safety problem over a time period. This can be expressed in different ways for example 1 in 10 risk is the same as 10% or 0.1.
Relative risk is used to compare risk in two groups for example users and non-users of a medicine.
If, for example, the absolute risk of haing a stroke in users of medicine X is 4 in 100, 4% or 0.04 whilst the absolute risk in non-users of medicine X is 2 in 100, 2 % or 0.02. Then the relative risk of having a stroke in users of medicine X compared to non-users of medicine X would be 200% or 2 times higher (that is the hazard ratio or odds ration would be 2)
If the absolute risk of having a stroke was significantly less in the above example, say 2 in 10,000 and the relative risk for users of medicine X was still 200%, than the absolute risk of having a stroke for users of medicine X was still 200%, thean the absolute risk of having a stroke for users of medicine X would still be quite low i.e. 4 in 10,000 or 0.04%
How do I report a problem (adverse event)?
Medsafe relies on, healthcare professionals, the public 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.
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. 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
View the Joint Adverse Events Notification System
How does the early warning system alert differ from Medsafe recall actions?
The early warning system alert advises healthcare professionals, consumers 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 healthcare professionals, consumers 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.
