Reporting adverse drug reactions

Information for health professionals

24 September 2014

The TGA developed this brochure to encourage health professionals to report adverse events to medicines and vaccines.

When a medicine or vaccine is first registered and made available in Australia, information about its safety and efficacy is usually available only from clinical trials. Clinical trials provide information about many of the possible adverse effects of a medicine, but they do not detect all possible adverse effects of a medicine.

The TGA monitors the safety of medicines and vaccines to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials.
Suspected adverse events reported by health professionals provide important information for the TGA's safety monitoring program.

If you would like copies of the brochure please contact the TGA on 1800 044 114 or email your request to adr.reports@tga.gov.au.

Reporting adverse drug reactions

 Every report counts

Even a small number of adverse event reports can help the TGA to identify significant new safety issues, as in the case of lumiracoxib (Prexige).

In the year after lumiracoxib became widely available, the TGA began an urgent safety review after eight reports of it being associated with serious liver damage were received.

As a result we immediately cancelled lumiracoxib’s registration and regulators in other nations did the same.

Your role in reporting an adverse event

As a health professional, you can play an important role in the ongoing safety of medicines and vaccines in Australia by reporting events to the TGA.

When you submit a report you contribute to the ongoing collection of information that enables the TGA to ensure the safety, effectiveness and quality of medicines and vaccines.

Why we need your reports

Analysis of adverse event reports is one way that the TGA monitors the safety of therapeutic goods used in Australia.
There is the potential for an adverse event to occur with the use of any medicine or vaccine - whether it is supplied:

  • on prescription
  • over-the-counter
  • as a complementary medicine.

When a medicine or vaccine is first registered and made available in Australia, information about its safety and efficacy is usually available only from clinical trials.

Postmarket monitoring of the safety of medicines and vaccines contributes to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials.

What actions does the TGA take?

Each adverse event report the TGA receives is entered into a database, which is continually analysed by TGA staff to identify potential emerging problems for detailed investigation.

If the TGA identifies a safety concern relating to a medicine or vaccine, we can take regulatory action.
This can include:

  • disseminating information for consumers and health professionals regarding the problem
  • updating the Product Information with new adverse effects, precautions or warnings
  • requiring postmarketing studies
  • imposing limits on their use
  • investigating manufacturing sites
  • recalling products from the market
  • suspending or cancelling products.

Reports become available on the publicly accessible Database of Adverse Event Notifications.

What you should report

You can report suspected adverse events to any medicine or vaccine available in Australia, including prescription medicines, over-the-counter medicines and complementary medicines.

The TGA particularly requests reports of:

  • suspected adverse events involving new medicines
  • suspected drug interactions
  • unexpected adverse events (i.e. reactions that are not described in the Product Information)
  • serious adverse events, such as those suspected of causing:
    • inability to work
    • admission to hospital
    • prolongation of hospitalisation
    • increased investigation or treatment costs
    • danger to life
    • birth defects
    • death.

Even if you are unsure whether to report, you should report serious adverse events.

What to include in a report

Each report must include:

  • contact details for the reporter
  • a patient identifier (e.g. initials, but not the full name of the patient or doctor)
  • a description of the adverse event
  • details of the medicine(s) or vaccine(s) suspected of causing the adverse event.

Please include as many other details as possible.

You don’t need to be certain, just suspicious

You can report any suspected adverse event involving a medicine or vaccine, even if you think it might already be known about.

You don’t need to be absolutely certain that the medicine or vaccine caused the reaction - a suspicion is enough.

All reports can contribute to the TGA’s investigation of a potential problem.

How you can report

You can report:

  • online: www.tga.gov.au/hp/problem.htm
  • via telephone: 1800 044 114
  • by post to: Therapeutic Goods Administration, PO Box 100, Woden, ACT 2606, Australia (please include the type of report in the address block)
  • via email: adr.reports@tga.gov.au
  • via fax:  +61 2 6232 8392.

Information about how the TGA handles personal information under the Privacy Act 1988 can be found here.

The TGA thanks you for reporting suspected ADRs. These reports are an essential part of ensuring the safety of medicines in Australia.