Database of Adverse Event Notifications: consumer questions and answers
29 November 2012
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More information is available from:
- What is the Database of Adverse Event Notifications (DAEN)?
It is an online database that you can use to find information about adverse events (also known as adverse reactions) to medicines that have been reported to the TGA. It includes information about medicines:
- prescribed or dispensed by a health professional, with a prescription
- purchased from a supermarket, pharmacy or another outlet without a prescription.
- Where does the information in the Database come from?
Information in the Database comes from reports made to the TGA by patients, consumers, health professionals and sponsors of medicines. These reports cover the years 1971 to up to 3 months prior to the date of access. The TGA uses this time to investigate each adverse event report.
- What does the TGA do with the information in the Database?
The TGA uses the information in the Database to help evaluate the benefits and risks of medicines and to monitor their safety once they are made available in the marketplace.
- Can someone who has reported an adverse event to the TGA be identified in the Database?
People who experience an adverse event reported to the TGA cannot be identified in the Database, or in adverse event reports made to the TGA. All personal information reported to the TGA, and included in the Database, is de-identified in line with the Privacy Act and National Privacy Principles.
- Why is the TGA publishing the Database?
The Database was created to support better health outcomes by providing access to information we gather while monitoring medicine safety in Australia. It is part of the work we do to monitor the safety of medicines for consumers.
As demand for information about medicines grows, along with our ageing population, publishing information on medicine safety 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.
Adverse event information reported to international regulatory agencies is also available online. This includes information from the US FDA, Health Canada, the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency and others.
- How do I use the Database?
Detailed information about how to use the Database can be found at Instructions for searching the Database of Adverse Event Notifications. Put simply, you can search the Database for a medicine's trade name or active ingredient. Once you have typed in 3 letters a list will appear. Then just click on the medicines you are interested in, select a date range and press 'Search'.
- Will the Database help me work out whether a medicine is safe to take?
No, the Database of Adverse Event Notifications (DAEN) cannot be used to evaluate whether a medicine is safe or not. It is not a substitute for professional medical advice.
The TGA cannot give medical advice and strongly encourages seeking the advice of a health professional if you or someone in your care suspect/s you are experiencing an adverse event with a medicine.
- If I find the medicine I'm looking for in the Database, does this mean that the medicine is dangerous and I should stop taking it?
No. Do not make changes to your medication regime based on information in the Database. Always seek the advice of a health professional before making any change to your medication.
If a medicine is authorised for use by the TGA, it means that the benefits are considered to outweigh its risks, if used as authorised. The benefit-risk balance is determined after a careful assessment of the benefits and side effects of the medicine. It is then up to a prescriber, patient or consumer to then decide if they wish to prescribe or take the medicine.
For things to consider when interpreting search results, see About the Database of Adverse Event Notifications: limitations of the data and search results.
- Why does the Database use medical terms that I don't understand?
Some of the more technical medical terms are from the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is an internationally used set of terms relating to medical conditions, medicines and medical devices.
MedDRA includes standardised terms for symptoms, signs, diseases, syndromes and diagnoses and medication errors. For example, neoplasms describes any type of growth, including cancer, no matter where it appears in the body.
The TGA uses these terms because they are the international standard in medicine terminology. These terms are used internationally by other medicines regulators. Their use allows the Database to be used to share information on medicines worldwide, improving medicine safety globally. Other terms used in the database include:
- Trade name - this is the brand name of the medicine
- Active ingredient - this is what makes the medicine work
- Not suspected - this medicine was taken at the time of the adverse event, but it is not suspected to be related to the adverse event.
- Suspected - the TGA thinks there is a possibility that the medicine caused the adverse event
- Interaction - an interaction between two or more medicines is suspected to have caused the adverse event; this is usually based on a history in the literature of interactions between the medicines concerned.
- What type of information is available in the search results?
Your search generates two types of report:
- The medicine summary - this report groups reported adverse events associated with a particular medicine together. It enables an assessment of the most commonly reported adverse events for particular medicines.
- The list of reports - this report contains more detailed information than the medicine summary. It lists the data for adverse events reported for particular medicines case-by-case, in chronological order. The details of each (de-identified) adverse event case are listed in the order of the date the report was entered into the Database.
See Database of Adverse Event Notifications: about the search results for more information.
- When I ran the same search on different days I got a different result. Why is that?
The Database is a 'living' database that is constantly updated and maintained to ensure it reflects the latest adverse event information. The number of adverse event cases can decrease from one month to the next for one or both of the following reasons:
- The TGA receives a follow-up report of an existing individual adverse event case. Sometimes these follow-up reports provide new information on the reported medicine, reported active ingredient or reported suspected side effect; and
- The TGA identifies that more than one report has been submitted about a particular patient, perhaps from a person's pharmacist and their doctor. When duplicate reports are identified, they are combined into a single report.
The database is then updated with this new or changed information.
- What is an adverse event? Is it different to a side effect?
Adverse events are unwanted and sometimes harmful outcomes. An adverse event may or may not be related to a medicine, and it is not the same as a side effect. Side effects are the known unintended effects of a medicine or treatment. More information about understanding the effects of medicines is available from NPS MedicineWise.
- How can I find information on the known side effects associated with a medicine?
Consumer Medicines Information (CMI) is available for all prescription and pharmacist-only medicines in Australia and is either included in the medicine pack or available in a separate leaflet from the pharmacist. CMI provides information on the safe and effective use of a prescription or pharmacist-only medicine. Information on known side effects is included in the CMI. You can also look up CMI information on the TGA website's CMI search facility.
- Why are adverse events monitored?
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 of a medicine because:
- they usually do not continue for long enough to detect reactions that take a long time to develop,
- they may not include enough patients to detect reactions that occur very rarely, and
- they may not include all of the different types of people who might eventually use the medicine and who might be more susceptible to some reactions, such as older people, children, pregnant women, or people with other medical conditions.
The TGA, like other medicines' regulatory agencies around the world, monitors the safety of medicines 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.
- How can I find more information on adverse events following immunisation?
The National Centre for Immunisation Research & Surveillance (NCIRS) in collaboration with the TGA prepares annual reports on adverse events following immunisation. These reports contain information on the rate at which an adverse event following vaccination is reported. They also contain information about serious adverse events and deaths that are reported to have occurred following a vaccine.
- What should I do if I or someone I know experiences an adverse event?
If you suspect that you are experiencing an adverse event you should consult a healthcare professional. You or the health professional can then report the event to the TGA. Detailed information on how and what to report is available on the TGA website.
- What adverse events should I report?
You should report any suspected adverse event, even if you think it might already be known about. You don't need to be absolutely certain that the medicine caused the reaction - a suspicion is enough. All reports contribute to the TGA's investigation of medicine safety.
Content last updated: Thursday, 29 November 2012
Content last reviewed: Thursday, 29 November 2012
Web page last updated: Tuesday, 18 December 2012