Greenbaum Deborah, Cheung Stephanie, Turner Claire, Mackinnon Fiona, Larter Claire
Pharmacovigilance Branch, Therapeutic Goods Administration, Canberra.
Aust Prescr. 2024 Dec;47(6):186-191. doi: 10.18773/austprescr.2024.056.
Reporting adverse events (adverse drug reactions) associated with medicines and vaccines assists with identifying previously unrecognised side effects and other safety concerns. Reporting adverse events to the Therapeutic Goods Administration is mandatory for sponsors (pharmaceutical companies), and strongly encouraged but voluntary for healthcare professionals and consumers. Adverse events should be reported even when causality is uncertain, as reports may contribute to identification of a safety signal for new or uncommon events. Suspected adverse events associated with new medicines and vaccines (registered in the last 5 years), and medicines included in the Black Triangle Scheme, should be prioritised for reporting. For other medicines, serious adverse events and unexpected adverse events should be prioritised. The Therapeutic Goods Administration analyses adverse event reporting data and uses signal detection methods to identify and evaluate emerging safety signals, which may lead to regulatory actions and communication to address safety issues.
报告与药品和疫苗相关的不良事件（药物不良反应）有助于识别先前未被认识到的副作用及其他安全问题。对于申办者（制药公司）而言，向治疗用品管理局报告不良事件是强制性的，而对于医疗保健专业人员和消费者则强烈鼓励但属自愿行为。即使因果关系不确定，也应报告不良事件，因为报告可能有助于识别新的或罕见事件的安全信号。与新药品和疫苗（过去5年内注册）以及列入黑三角计划的药品相关的疑似不良事件应优先报告。对于其他药品，应优先报告严重不良事件和意外不良事件。治疗用品管理局分析不良事件报告数据，并使用信号检测方法来识别和评估新出现的安全信号，这可能会导致监管行动并进行沟通以解决安全问题。
