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Early Warning System: consumer questions and answers

5 July 2013
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A safety concern is any potential safety problem linked to a medicine or medical device (therapeutic product). Safety concerns include known safety problems, changes in the reporting pattern of known problems, new problems and coincidental events. At the time the safety concern is detected, the TGA may not know if the concern is really caused by the medicine or medical device.

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 therapeutic product you are using, please contact your health professional.

Monitoring communications highlight potential safety concerns identified by the TGA 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 TGA. Your report will contribute to our monitoring of these products.

The TGA advises all consumers to follow the advice provided in the alert communication. Consumers should NOT stop using a medicine or medical device without first seeking the advice of their health professional; unless this is advised in the alert communication.

Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe.

The TGA uses many sources of information to identify safety concerns. These include adverse event notifications, published papers, sponsors and manufacturers, clinical studies, researchers and health professionals, and other regulatory authorities and government agencies.

The TGA investigates safety concerns to determine if there is a link between the concern and the therapeutic product. The TGA reviews information on the safety concern and may seek advice from experts, for example the Advisory Committee on the Safety of Medical Devices. The TGA also works closely with other regulatory authorities.

If there is a demonstrated link between the therapeutic product and a safety concern, the TGA will consider the appropriate action(s) that needs to be taken to improve the safe use of the medicine or medical device.

The TGA has to consider the balance between the benefits offered by a therapeutic product 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 an appropriate response. There is a range of actions that can follow when a potential safety concern is identified. These include:

  • informing health professionals and consumers through alerts and other communications such as articles in the Medicines Safety Update
  • requiring changes be made to the Product Information
  • changing the conditions of use or narrowing the population in which it can be used
  • changing the legal status of a medicine, for example making a medicine only available with a doctor's prescription
  • requesting the sponsor complete a study to investigate the concern
  • withdrawing or suspending the market approval for the medicine or medical device
  • recalling the medicine or medical device.

In some cases, no action may be recommended and the TGA will continue to monitor the safety concern.

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 the TGA does to monitor the safety of medicines and medical devices for consumers.

As demand for information about medicines and medical devices grows, along with Australia's ageing population, a reputable government agency publishing information on medicine and medical device safety concerns online improves public access to this important information. The TGA is committed to improving transparency to build trust and confidence in its work.

Further information on the Early Warning System, including the decision criteria used by the TGA to decide when to publish a communication, can be found at: Trans-Tasman Early Warning System: Processes in Australia and New Zealand.

Adverse events are unwanted and sometimes harmful outcomes from 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).

Side effects are known unintended effects of a medicine or medical device.

Information on known side effects is included in the Consumer Medicines Information (CMI), which is available for all prescription and pharmacist-only medicines in Australia. CMI provides information on the safe and effective use of a prescription or pharmacist-only medicine and is either included in the medicine pack or available in a separate leaflet from the pharmacist. You can also look up CMI information on the TGA website's CMI search facility.

The known risks for other types of medicines (including sunscreens, and many vitamin, mineral, herbal and homoeopathic products) and medical devices are generally outlined in the product information/instructions for use and/or labelling supplied with the therapeutic product. Your health professional can also provide help and assistance on how to use medicines or medical devices.

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 probability of a risk occurring and this may be expressed as a fraction or a percentage.

Relative risk is a proportional measure used to compare risk in two groups.

An example of absolute risk and relative risk in describing the difference between two treatments is available on the NPS MedicineWise website.

The TGA relies on the public, health professionals and industry to report problems with medicines or medical devices - this allows us to identify and respond to safety concerns. You can report problems to the TGA using one of the available reporting options outlined on the TGA website.

If you are experiencing an adverse event or think you may be experiencing one, please seek advice from a health professional as soon as possible. The adverse event should then be reported to the TGA.

The Database of Adverse Event Notifications (DAEN) allows you to search information from adverse event reports that the TGA has received in relation to medicines used in Australia from 1 January 1971 and in relation to medical devices used in Australia from 1 July 2012.

The TGA and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) also publish information from medicine and medical device adverse events reported in Australia and New Zealand in the Joint Adverse Event Notifications System (JAENS).

The Early Warning System alert communication advises consumers, health professionals and industry about new safety information on therapeutic products following the outcome of an investigation. An alert does not necessarily mean that a product is considered to be unsafe.

A recall action provides advice to consumers, health professionals and industry about a defective therapeutic product and the recall action undertaken in the Australian market. Recall actions are usually due to unacceptable quality, safety, efficacy/performance or presentation.

A summary of recent recall actions initiated in Australia can be viewed in the publicly accessible and searchable database: System for Australian Recall Actions (SARA).

Additional information on the Early Warning System, including the decision criteria used, content of communications, publication and update process of communications, can be found at Trans-Tasman Early Warning System: Processes in Australia and New Zealand.