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Early Warning System: health professional 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.

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 the TGA 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 TGA. Your report will contribute to the TGA's monitoring of these products.

The TGA provides up to date advice for health professionals on the safe use of medicines or medical devices in alert communications based on its investigation findings. Health professionals should use clinical judgement in applying this information to individual patients.

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 and individual patient factors, such as previous treatment, disease severity, alternative treatment options and patient preferences, should be considered.

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 (often called a causal association) between the event and a medicine or medical device. 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 medicine or medical device 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 TGA is responsible for ensuring that therapeutic products available for supply in Australia are safe and fit for their intended purpose (labelled use).

Use of a medicine or a medical device outside the specified indication/s or intended purpose for supply is often referred to as 'off label' use. For example, using a medicine or medical device:

  • for an indication or an intended purpose not specified in the product information or the package label
  • in a different population to that intended (e.g., children or pregnant women)
  • at a different dose to that recommended
  • via a different route of administration

If the recommended use of a medicine or medical device changes with the result that the medicine or medical device is being used 'off label' the patient should be informed. The patient and health professional will need to make a joint decision on treatment options.

Information on accessing unapproved therapeutic products is available on the TGA website.

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 TGA'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. 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.

Product Information (PI) for prescription and pharmist-only medicines is published on the TGA website. The PI provides a summary of the scientific information relevant to the safe and effective use of a prescription or pharmacist-only medicine.

The known risks for other types of medicines (including sunscreens, and many vitamins, 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.

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 for example users and non-users of a medicine. It is important when evaluating the significance of a relative risk to consider the context of the affected population (or denominator information).

For example, if the absolute risk of having 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 ratio 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 would still be quite low, i.e. 4 in 10,000 or 0.04%.

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.

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).

The Early Warning System process applies to all medicines and medical devices that have been entered on the Australian Register of Therapeutic Goods (ARTG).

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.