An important aspect to good medication management is the reporting of adverse drug reactions. MIMS assists healthcare professionals in Australia to report these reactions by providing the TGA’s Adverse Drug Reaction Reporting Form within the MIMS electronic products.
Therapeutic Goods Administration (TGA), Australia
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.
To understand more about how this process works and how you can contribute go to:
TGA Database of Adverse Event Notifications
Released 1 August 2012
Consumers, health professionals and industry can now access online information about adverse events to medicines that have been reported to the Therapeutic Goods Administration (TGA) since 1971.
The TGA and the New Zealand regulator, Medsafe, have worked together on the development of two publicly accessible databases that provide information on adverse events reported to each organisation. This project is part of the staged implementation of the move to becoming the Australia New Zealand Therapeutic Products Agency.
In 2011, the Therapeutic Goods Administration (TGA) received over 14,000 adverse event reports for medicines. These reports came from a wide range of sources, including from members of the public, GPs, other health professionals and from the therapeutic goods industry.
The Database of Adverse Event Notifications (DAEN) allows you to search these reports:
US Food and Drug Administration (FDA)
Within the Center for Drug Evaluation and Research (CDER), the Division of Medication Error Prevention and Analysis (DMEPA) reviews medication error reports on marketed human drugs including prescription drugs, generic drugs, and over-the-counter drugs. The DMEPA uses the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) definition of a medication error. Specifically, a medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."
For more information on the FDA go to:
European Medicines Agency
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
The Agency constantly monitors the safety of medicines through a pharmacovigilance network, and takes appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised. The Agency has commenced the publication of suspected side effect reports for medicines authorised in the European Economic Area. The reports come from the EU medicines safety database, EudraVigilance, and are one of the ways in which the EMA monitors the ongoing risk vs reward of medicines. The data can be viewed by age group, sex, type of suspected side effect and by outcome.
For more information go to: