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Is your organisation ‘Black Triangle’ ready?
In 2017, The Therapeutics Goods Administration (TGA) sought comment on their proposal to implement a range of enhancements to their existing Medicines Vigilance Framework. In this article, we take a look at what the new ‘Black Triangle’ Scheme means and how it will impact the healthcare industry.
New enhanced medicines vigilance
According to the TGA, the intent of the Black Triangle Scheme is to provide a simple means for practitioners and patients to identify certain types of new prescription medicines, and to encourage the reporting of adverse events associated with their use.
Rolling out in February 2018, the new enhancements include:
- A ‘Black Triangle’ Scheme, similar to those currently in place in the United States and Europe, designed to alert both healthcare professionals and patient consumers that a particular medicine is newly available and to report adverse events associated with the medicine. These triangles will start to appear on the PI and CMI documents for new medicines and those with ‘high risk’ profiles.
- Product Information (PI) reformat in association with medicine sponsors, to ensure that important prescribing information (e.g., indications, contraindications, precautions, adverse events etc.) is easily accessible to the prescriber
- Pharmacovigilance (PV) inspection program which will allow the TGA to proactively ensure sponsoring companies have appropriate pharmacovigilance in place and are compliant with their legal responsibilities e.g., reporting of serious adverse events
- Risk Management Plan (RMP) designed to enhance compliance monitoring and keep track of any changes to existing medicines that may introduce a new safety concern e.g., new indications or patient populations such as children or the elderly
On top of this, the new scheme is set to improve the collection and use of data to better support compliance and monitoring and offer a new IT system for the Adverse Events Management System (ADRS). At the same time, it will open new international information sharing with the WHO to strengthen Australia’s contribution to global pharmacovigilance efforts
What does this mean for healthcare professionals?
Whilst many of the core changes will have a direct impact on pharmaceutical manufacturers, there will be an inevitable flow onto healthcare professionals.
Patients and their advocates will be expected to continue to take a more proactive approach to the medicines. As an example, in 2016, concerned parents called for clearer warnings about medication side effects when a correlation was noted in association with an asthma medicine and neuropsychiatric adverse events.
MedicalDirector has one of the most comprehensive and up to date sources of PI and CMI documents in Australia, curated from three separate sources. So irrespective of whether you’re using AusDI, MedicalDirector Clinical or MedicalDirector Helix, you can be confident that you’re providing your patients with the information they need about their medicines.
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