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Adverse drug reactions: frequently asked questions

What is the Adverse Drug Reactions Unit (ADRU)?

The Adverse Drug Reactions Unit (ADRU <http://www.tga.gov.au/adr/index.htm>) is a business unit within the Therapeutic Goods Administration (TGA), Commonwealth Department of Health and Ageing. ADRU coordinates and monitors the reporting of suspected adverse reactions to medicines in Australia. ADRU also provides the secretariat for the Australian Adverse Drug Reactions Advisory Committee (ADRAC). The TGA is responsible for the regulation of medicines and medical devices in Australia.

What is the Adverse Drug Reactions Advisory Committee (ADRAC)?

The Adverse Drug Reactions Advisory Committee (ADRAC) <http://www.tga.gov.au/adr/adrac.htm> is a group of independent medical experts who provide advice regarding issues relating to the safety of medicines.

What is an adverse drug reaction?

The World Health Organization defines an adverse drug reaction as "A response to a drug which is noxious and unintended, and which occurs at doses normally used or tested in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function".

An adverse drug reaction is considered to be serious when it is suspected of causing death, danger to life, admission to hospital, prolongation of hospitalisation, absence from productive activity, increased investigational or treatment costs, or birth defects.

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Why monitor adverse drug reactions?

Before registration and marketing of a medicine in Australia, its safety and efficacy experience is based primarily on the use of the medicine in clinical trials. These trials mainly detect common adverse reactions. Some important reactions, such as those which take a long time to develop, or those which occur rarely, may not be detected in clinical trials. In addition, the controlled conditions under which medicines are used in clinical trials do not necessarily reflect the way they will be used in practice. So in order to gain a more comprehensive safety profile of a medicine, a continuous post-marketing monitoring system is essential.

How are adverse reactions monitored after a medicine has been marketed?

In Australia, adverse reaction reporting is coordinated by the Adverse Drug Reactions Unit (ADRU) at the Therapeutic Goods Administration (TGA).

The system for monitoring adverse reactions in Australia is by voluntary reporting by health professionals and consumers. When a health professional or consumer suspects an adverse reaction to a medicine has occurred, they can report it directly to the Adverse Drug Reactions Advisory Committee (ADRAC) using a "blue card" <http://www.tga.gov.au/adr/bluecard.htm>.

All reports are individually reviewed by medical and professional staff.

What information does ADRAC need in a report?

The Blue Card <http://www.tga.gov.au/adr/bluecard.htm> provides a good checklist for the information to include in a report. Only if all relevant data is provided can a complete assessment be made of the association between the medicine and the adverse reaction.

All reports should contain the following data:

The patient and reporter:

  • Patient information (initials/UR No, date of birth/age, sex)
  • Reporter information (name, address, phone number)

The reaction:

  • A description of the reaction
  • Date of onset of reaction
  • Details of any treatment of the reaction
  • Outcome of the reaction and date of the outcome

The medicine(s):

  • Any medicine(s) administered before the onset of the reaction - brand names preferred
  • Dates of starting and stopping the suspected medicine(s) and any other medicines
  • Doses and reasons for use for all medicines

The following additional data (if available) would be very useful:

  • Medical history
  • Relevant laboratory data (haematology, biochemistry, imaging, serology, biopsy, etc)
  • AUST L number for complementary medicines (this can be identified by the letters 'AUSTL' followed by some numbers and can be found on the bottle or packaging of the product)
  • Batch number for vaccines and for all cases of suspected quality control (manufacturing fault) problems
  • In cases where the outcome is fatal, the circumstances, date, mode, and cause of death. If a postmortem examination or coroner's enquiry was conducted, a copy of the post-mortem or coroner's report should be forwarded to ADRAC when available

If any of the above information is contained in existing documentation such as a discharge summary or specialist report, photocopies of those documents can be provided.

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Who can report adverse reactions?

Anyone can. Each year the Adverse Drug Reactions Advisory Committee (ADRAC) receives approximately 12,000 reports of suspected adverse drug reactions. About one-third of these come from General Practitioners, just under one-third from hospitals, about a quarter from pharmaceutical companies, and the remainder from specialists, community pharmacists and consumers. Consumers are encouraged to report through a health professional. Please note that anonymous reports are not accepted.

What happens to an adverse reaction report?

When reports are received, they are reviewed by professional and medical staff and entered into the national adverse reaction database. The data are then analysed to identify safety signals. A signal is a preliminary indication of a medicine-related safety issue and by itself does not indicate a causal association. When a signal is identified, a detailed evaluation is undertaken to establish whether a true causal association exists between the medicine and the adverse reaction.

What information is available from ADRAC?

The Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm>, a quarterly publication, provides useful information on adverse reactions, including important issues arising from reports submitted to ADRAC. The Bulletin is distributed to physicians, pharmacists and other health professionals and is available electronically.

Information in the form of summary reports and case summary reports are available on request from the Adverse Drug Reactions Unit at the TGA. Requests can be made by email to or by ringing the ADRAC enquiries line on 1800 044 114.

What are the limitations of adverse reaction information?

There are a number of limitations of a spontaneous reporting system which make it difficult to undertake epidemiological analyses of the data. The main restrictions are under-reporting and the lack of reliable exposure (usage) data, which make it difficult to calculate the incidence of adverse reactions. Furthermore, the information gained from an adverse reaction report is often incomplete.

What actions can be taken by the TGA?

Possible regulatory actions vary from continuing observation to cancelling the registration of the drug. Other possibilities include:

  • Informing health care professionals and consumers about the risks
  • Re-assessment of the benefit-risk profile of a medicine
  • Requiring product labelling changes (including the addition of contraindications, warnings, precautions and adverse reaction information to the Product Information and Consumer Medicines Information)
  • Requesting post-marketing studies

What actions cannot be taken by the TGA?

  • Legal action against health care professionals
  • Provision of medical advice

How can I obtain adverse reaction reporting guidelines?

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