Joint Adverse Event Notifications System: Consumer Questions and Answers
It is an online system that you can use to find information about suspected adverse events (also known as adverse reactions) to medicines that have been reported to the TGA and Medsafe. 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 JAENS come from?
Information in JAENS comes from reports made to the TGA and to the Centre for Adverse Reactions Monitoring (CARM) part of the New Zealand Pharmacovigilance Centre by patients, consumers, health professionals and sponsors of medicines. These reports cover the years 2000 up to 3 months prior to the date of access. The TGA, Medsafe and CARM use this time to investigate each adverse event report.
Note: Australian adverse event reports starting from 1971 up to 3 months prior to the date of access are available in the Database of Adverse Event Notifications (DAEN) on the TGA website.
New Zealand adverse event reports from 2000 up to 3 months prior to the date of access are also available in the Suspected Medicine Adverse Reaction Search (SMARS) on the Medsafe website.
What does the TGA and Medsafe do with the information in JAENS?
The TGA and Medsafe use the information in JAENS to help evaluate the benefits and risks of medicines and to monitor their safety in general use.
Can someone who has reported an adverse event be identified in JAENS?
People who experience an adverse event reported to the TGA and CARM cannot be identified in JAENS, or in adverse event reports made to the TGA or Medsafe. All personal information reported, and included in JAENS, is de-identified in line with the relevant privacy legislation and National Privacy Principles in the country (Australia or New Zealand) where the report was made.
Why are the TGA and Medsafe publishing JAENS?
The Australian and New Zealand Governments have agreed to proceed with a joint scheme for regulation of therapeutic goods (ie medicines, medical devices, etc).
The publication of a Joint Adverse Event Notifications System is part of the transition process to a joint regulator, Australia New Zealand Therapeutic Products Agency (ANZTPA).
JAENS was created to support better health outcomes by providing access to information we gather while monitoring medicine safety in Australia and New Zealand. 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 and Medsafe are committed to improving transparency to build trust and confidence in our 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 JAENS?
Detailed information about how to use JAENS can be found here. Put simply, you can search JAENS for a medicine’s trade name or active ingredient. Once you have typed in three letters a list will appear. Then just click on the medicines you are interested in, select and a date range and press ‘Search’.
Will JAENS help me work out whether a medicine is safe to take?
No, JAENS cannot be used to evaluate whether a medicine is safe or not. It is not a substitute for professional medical advice.
If you or someone in your care suspect/s you are experiencing an adverse event with a medicine you should consult a health professional.
If I find the medicine I’m looking for in JAENS, 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 JAENS. Always seek the advice of a health professional before making any change to your medication.
If a medicine is authorised for use in Australia or New Zealand, 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 Joint Adverse Event Notifications System: limitations of the data and search results.
Why does JAENS 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.
JAENS use these terms because they are the international standard in medicine terminology. These terms are used by other medicines regulators. Their use allows JAENS to be used to share information on medicines worldwide, improving medicine safety globally. Other terms used in JAENS 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 or CARM 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 JAENS.
See Joint Adverse Event Notifications System: about the search results for more information.
When I ran the same search on different days I got a different result. Why is that?
JAENS is a 'living' system 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 or CARM 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 or CARM 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.
JAENS 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?
In Australia, Consumer Medicines Information (CMI) is available for all prescription and pharmacist-only medicines and is either included in the medicine pack or available in a separate leaflet from the pharmacist. In New Zealand, CMI is available for most prescription and pharmacist-only medicines 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.
In Australia, you can also look up CMI information on the TGA website’s CMI search facility.
In New Zealand, you can also look up CMI information on the Medsafe website’s CMI search facility.
Why are adverse events monitored?
When a medicine is first registered and made available in Australia or New Zealand, 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 and Medsafe, 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 and Medsafe’s safety monitoring program.
How can I find more information on adverse events following immunisation?
In Australia, 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.
In New Zealand, independent information about immunisation is provided by the Immunisation Advisory Centre.
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.
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 investigation of medicine safety.