more_vert
I WRITE in response to Barbara Mintzes’ and Ian Boyd’s opinion piece published in InSight+ on 14 November 2022.
The Therapeutic Goods Administration (TGA) welcomes feedback and is committed to continuously improving processes and communications. However, the article demonstrates a lack of understanding about contemporary pharmacovigilance practices applied by the TGA and refers to out-of-date information, particularly relating to safety communication.
Managing medicines safety requires adaptation of our response to the particular pharmacovigilance issue at hand. There are often good reasons why an action taken in other countries, including the application of Boxed Warnings, is not appropriate or effective in the Australian context. This is especially the case when the clinical use of the particular medicine is different here or other risk minimisation activities may already be in place.
One of the TGA’s primary safety activities is ensuring Product Information for prescribers and other health professionals is kept up-to-date. In the past 18 months, we have identified the need for over 277 safety-related updates to Product Information documents and the relevant changes to the Product Information have been made. Additionally, more than 117 safety-related updates have been made to Consumer Medicine Information leaflets in 2022 alone. These numbers are in addition to the many safety updates that are self-generated by sponsors.
In this context, Dear Healthcare Professional Letters are communications sent by medicine sponsors to health care professionals that notify them of a safety-related change to Product Information. They are just one tool in a kit of safety communication resources.
The TGA has made a number of enhancements relating to safety communication and transparency. Since the beginning of 2021, we have published over 30 Medicines Safety Update articles and about 80 coronavirus disease 2019 (COVID-19) vaccine safety reports. Additionally, we now regularly publish a collated update of recent safety-related changes to Product Information. This is designedpharmacovigilance system to be easier for health professionals to review. The number of changes featured within these updates far exceeds the aggregate numbers quoted in the article by Mintzes and Boyd. For example, the update for September/October 2022 alone contained 78 safety updates.
The TGA is focused on ensuring that our communications are well targeted, and we will continue to work with health professional peak bodies, craft groups and other stakeholders to deliver timely, reliable and valuable safety information to appropriate audiences.
The InSight+ article contends that the quality of the pharmacovigilance system can be inferred by the proportion of reports from health professionals. Medicine sponsors are required by law to report serious medicine adverse events and significant safety issues within mandated time frames. Therefore, it is not surprising that a large proportion of reports received are from sponsors. These reports should certainly not be discounted as low quality. Increasing numbers of adverse event reports (regardless of source) and regulatory actions taken in response to new safety information show that our pharmacovigilance system is working. Our experience with COVID-19 vaccine monitoring demonstrates a culture of increasing reporting by health care professionals and consumers in Australia.
We continue to work closely with health professional groups to improve awareness and ease of reporting. This includes investigating the ability for general practitioners to report adverse events from the software they use during patient consultations, which will greatly reduce the time and effort involved.
InSight+ readers can have confidence in Australia’s and our ongoing commitment to effective communication.
Adjunct Professor John Skerritt is the Deputy Secretary of the Department of Health and Aged Care and Head of the TGA.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
Subscribe to the free InSight+ weekly newsletter here. It is available to all readers, not just registered medical practitioners.
If you would like to submit an article for consideration, send a Word version to mjainsight-editor@ampco.com.au.
Loading ...
The TGA a over 90% funded by the very pharmaceutical companies they are meant to monitor. This is a complete conflict of interest and should never have been allowed to happen. There have been more injuries from these recent Covid 19 injections in the last 2 years than from all the combined ‘vaccines’ ever, yet still they have not stopped them or investigated the deaths and injuries. Absolutely no trust or faith in their integrity and intent of keeping the people of Australia safe from pharmaceutical companies who seek to make millions without care to the recipients of it’s products.
Can I ask how the Pharmacy Guild bypasses TGA recommendations? I don’t understand how an S4 drug can be “prescribed” by a pharmacist. Surely by making it S4 the TGA has decided over the counter supply is not safe. Can you please explain how this works? Because if State governments can essentially override the TGA’s recommendation surely a plank of our governance and safety has fallen. It’s a genuine question. Especially with increasing monitoring of GP prescribing.
As of today’s look at the TGA website, all Covid vaccines remain ‘provisionally approved’. I’m not sure this is “effective communication” to the general public, when anti-vaxxers and assorted loonies stress the risks more than the benefits.
In particular, coming from a body which initially warned doctors not to advertise Covid vaccines, any regulator’s reticence about the vaccines can be inferred to be an acknowledgement of their risks. Standard websites for commercial goods rate products, and many give a ‘recommended’ status, e.g. a Heart Foundation tick or a star rating on food products.
Globally there have been over 6 million Covid deaths, and the evidence of net benefit of vaccines is clear. We’ve had them for 2 years in Australia. When will TGA drop the ‘provisional’ and just say ‘approved’? Or even better, ‘strongly recommended’?
When will the TGA do the basic due diligence of analysing the contents of the vials, given the number of doctors and scientists doing their own investigations and reporting strange, unexplained structures and phenomena?
Evey time that a prescribed medicine is stopped before the patient has used all of the supply, our electronic clinical record system should ask us for the reason. If we record that the reason was any kind of adverse effect, whether it caused symptoms or not (e.g. biochemical disturbance), our software should automatically send an adverse drug reaction report to the TGA.