Reporting medicine and vaccine adverse events

Everyone plays an important role in monitoring the safety of medicines, including vaccines, by reporting any suspected adverse events to the TGA.

An adverse event is any untoward medical occurrence in a patient administered a medicine and which does not necessarily have to have a causal relationship with this medicine. An adverse event can therefore be any unfavourable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicine, whether or not considered related to this medicine.

Why report adverse events to medicines and vaccines to the TGA?

When a medicine 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 because:

  • they usually do not continue for long enough to detect adverse events that take a long time to develop,
  • they do not include enough patients to detect adverse events that occur rarely, and
  • they do not include all of the different types of people who might eventually use the medicine and who might be more susceptible to some adverse events, such as older people, children, pregnant women, or people with other medical conditions.

The TGA, like other regulatory agencies around the world, monitors the safety of therapeutic goods 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 the public and health professionals provide important information for the TGA's safety monitoring program.

Who can report an adverse event?

Anyone can.

Each year the TGA receives more than 12,000 reports of suspected adverse events to medicines and vaccines. About 40% of these reports come via pharmaceutical companies, and the rest are reported directly to the TGA by general practitioners (about 15% of all reports), hospitals (20%) and specialists, community pharmacists, state and territory health departments and consumers.

The TGA asks for contact details from people making reports so that it can seek further information about suspected adverse events. The TGA does not accept anonymous reports.

The TGA encourages consumers to report suspected adverse events through a health professional so that it can seek further information if needed.

Which medicines and vaccines should I report?

The TGA requests reports of suspected adverse events to any medicine available in Australia, including:

  • Prescription medicines
  • Vaccines
  • Over-the-counter medicines that are purchased without a prescription
  • Complementary medicines, including
    • Herbal medicines
    • Naturopathic or homeopathic preparations
    • Nutritional supplements such as vitamins and minerals

Which events should I report?

You don't need to be certain, just suspicious!

It may be difficult to determine whether a particular medicine or vaccine caused an adverse event in an individual case, but all reports can help to build up a picture of the role of a product in causing an adverse event.

The TGA particularly requests reports of:

  • All suspected adverse events to new medicines or vaccines
  • All suspected interactions
  • Unexpected adverse events (ie, adverse events that do not appear in the product information)
  • Serious adverse events, such as those suspected of causing:
    • Death
    • Danger to life
    • Admission to hospital
    • Prolongation of hospitalisation
    • Absence from productive activity
    • Increased investigational or treatment costs
    • Birth defects

What information is required when reporting an adverse event?

When reporting an adverse event to a medicine or vaccine, reporters are asked to provide the following information:

  • A patient identifier (such as initials, hospital UR number, date of birth or age)
  • Contact details for the reporter (name, address, phone number)
  • A description of the event
  • Medicines or vaccines suspected of causing the event
  • Any other medicines the patient was taking or vaccines administered
  • Date of onset of the adverse event
  • Date of starting and stopping the suspected medicines
  • Date of starting and stopping any other medicines
  • Details of how the adverse event was treated
  • The outcome of the event, and the date of the outcome

If available, reporters are also asked to provide:

  • Information about the patient's medical history
  • Relevant laboratory data (haematology, biochemistry, imaging, serology, biopsy, etc.)
  • For complementary medicines, the AUST L number, which can be found on the medicine packaging
  • For vaccines and any problems thought to be related to a manufacturing fault, the batch number
  • In cases where the outcome is death, the circumstances, date and cause of death. If a postmortem examination or coroner's enquiry was conducted, a copy of the report is very useful.

Reporters can provide the above information in copies of any relevant documents, such as discharge summaries, specialist reports or laboratory results.

Why does the TGA ask for this information?

By providing all information relevant to a specific adverse event, you can help TGA staff to assess the possible role of the medicine or vaccine in causing the adverse event.

Providing as much information as possible will reduce the need for the TGA to follow up. However, it is important not to delay reporting an adverse event if some information is not available. If we require additional information, someone from the TGA will contact you.

The TGA asks for contact details from people making reports so that it can seek further information about suspected adverse events. The TGA does not accept anonymous reports.

Any information identifying the reporter or patient is kept confidential.

Privacy statement

Information in this report is collected to assist in the post market monitoring of the safety of therapeutic goods under the Therapeutic Goods Act 1989 (the Act). All reports are assessed and entered into the Therapeutic Goods Administration's (TGA's) Australian Adverse Drug Reactions System (the ADRS).

The TGA collects personal information in this report to:

  • Assess the safety of medicines and vaccines under the Act.
  • Contact the reporter of the adverse event if further information is required.
  • Contact representatives of entities that supply therapeutic goods, to discuss reported adverse events.
  • Check that the same information has not been received multiple times for the same adverse event.

At times, this information is collected from someone other than the individual to whom the personal information relates. This can occur when an adverse event is reported to a person or an entity other than the TGA (such as a health professional or a hospital), and that person or entity passes the information on to the TGA.

Personal information collected in this report may be disclosed by consent or where the disclosure is required by, or authorised under, a law (for example, under section 61 of the Act). Where a report relates to vaccine events, personal information about the reporter or the patient may be disclosed to State and Territory health agencies under subsection 61(3) of the Act.

What happens to reports

Each report that the TGA receives is entered into the Australian Adverse Drugs Reactions System (the ADRS).

Information recorded in the database includes the adverse event, the medicines or vaccines involved, and other relevant information, such as relevant medical history, laboratory results and how the adverse event was treated.

Reports are entered into the ADRS on average within 2 working days of receipt. A letter of acknowledgement is sent to the reporter. Each report is given a unique identifying number, and reporters are encouraged to submit any further information about the case, quoting the identifying number, so that it can be added to the report.

In some cases, TGA staff request further information from the reporter if it could assist in assessing the possible role of the medicine or vaccine in the reported adverse event, or if the report is of a event of special interest to the TGA.

The information in the ADRS is regularly analysed by TGA staff to identify safety signals. A safety signal is a 'flag' for a possible safety concern. When the TGA identifies a signal, it undertakes a detailed evaluation to establish the possible role of the medicine or vaccine in causing the adverse event. Analysis of adverse event reports is one way that the TGA monitors the safety of medicines and vaccines used in Australia.

Three months after a report has been entered into the ADRS, data are transferred to the publicly accessible Database of Adverse Event Notifications. The three month time lag enables TGA staff to check and analyse the information in the ADRS.

The TGA cannot give medical advice and strongly encourages consumers to talk with a health professional if they think they might be experiencing an adverse event.

Actions the TGA can take in response to a safety concern

If the TGA identifies a safety concern relating to a medicine or vaccine, it can take regulatory action to ensure that the product continues to have acceptable safety, efficacy and quality for its intended use. The TGA also seeks to ensure that health professionals and the public are aware of the safety concern and any changes to the availability and recommended use of the medicine or vaccine.

Actions the TGA can take in response to a safety concern include:

  • informing health professionals and consumers through alerts and articles in Medicines Safety Update
  • requiring changes to product labelling, or adding warnings, precautions and adverse event information to the Product Information and Consumer Medicines Information
  • cancelling the registration of the product, or limiting the population in which it can be used
  • requiring the sponsor to undertake post-marketing studies to investigate the safety concern if more information is needed before a judgment can be made about the need for further action.

Data collected through adverse event reporting

Specified kinds of information about reported adverse events can be released to the public by the Secretary under subsection 61(5C) of the Act. The information includes such details as the medicine reported to have been involved in an adverse event, and statistics such as the number of cases of reported adverse events relating to a medicine for any particular period of time. This information does not include any "personal information" within the meaning of the Privacy Act 1988 - that is, information from which an individual's identity might be apparent or reasonably ascertainable.

Reports of adverse events received by the TGA are added to the Database of Adverse Event Notifications.

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