Asia-Pacific Roundup: Australia’s TGA adds adverse event search feature in response to feedback

Australia’s Therapeutic Goods Administration (TGA) has added sponsor search capabilities to its Adverse Event Management System (AEMS) web portal. The changes follow a consultation that identified a need to improve an inefficient process for TGA and sponsors and delays in access to information.

Sponsors can search for reports using the updated AEMS web portal, filter results using multiple data attributes, and download de-identified Public Case Detail and Case Line Listing reports for inclusion into their pharmacovigilance systems. The search feature is designed to allow sponsors to access adverse event data without contacting TGA.

“Sponsors can now log into the AEMS portal using their AEMS/TGA Business Services accounts and view, search, filter and extract data on adverse event reports submitted since 2018,” TGA wrote. “Through this new functionality sponsors have greater and faster access to adverse event data to support their pharmacovigilance obligations and analysis of safety signals.”

The function covers adverse events submitted by parties other than the sponsor organization, containing the same active ingredient as their products but where the trade name was not specified, and with a decision of “rejected” or “withdrawn.” TGA has updated its AEMS guidance with information about the new search capabilities. The text describes how to perform and refine searches and generate reports.

Under the old system, sponsors accessed data by manually searching the public Database of Adverse Event Notifications (DAEN) - Medicines and sending email requests to TGA. During the consultation, which ran in early 2022, TGA called both methods “inefficient” and said they delay access to safety information.

The inefficiencies led TGA to propose updating AEMS to allow sponsors to view and export relevant de-identified medicine adverse event data from TGA systems using their existing sponsor authentication processes. Before implementing the feature, TGA sought feedback on the type of data sponsors wanted to view and extract from AEMS, their preferred formats, and the use of international adverse event standards.

In submitted comments, AbbVie said it searches DAEN for basic information and directly contacts TGA for public case details weekly. Like Novartis and Teva, who also responded to the consultation, AbbVie imports the data into its pharmacovigilance system and uses it to supplement reporting and inform internal safety monitoring.

The respondents would use the proposed AEMS search capabilities slightly differently. AbbVie and Teva told TGA they would use the proposed search function to view tailored AEMS data, with AbbVie requesting access to information such as age, ethnicity and date of death in addition to what is included in DAEN.

Novartis told TGA it would not use the proposed functionality to view tailored AEMS data but did want to extract relevant individual case safety reports (ICSRs) directly into its pharmacovigilance system. The Swiss firm requested an extraction system that complies with E2B, an International Conference on Harmonisation (ICH) standard, and is “tested before moving to production.” All three sponsors want to receive ICSRs directly via their EDI Gateway in the E2B R3. Novartis called the process “much simpler.”

Having added the search feature, TGA is “considering other improvements to how we receive and share medicine adverse event data in the future, including the voluntary adoption of the ICH E2B(R3) standard.”

TGA Notice, Consultation Responses

Medsafe opts against class-wide action on interleukin inhibitors after monitoring safety

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) opted not to apply a class-wide warning about the possible risk of pancreatitis when taking interleukin inhibitors.

Medsafe began monitoring the safety of the class of medicines in May 2023 in response to discussions at its Medicines Adverse Reaction Committee (MARC) meeting. The class of medicines is used to treat conditions such as asthma, plaque psoriasis and rheumatoid arthritis.

MARC found a lack of strong evidence of an association between interleukin inhibitors and pancreatitis but was concerned enough to recommend that Medsafe encourage reporting the potential adverse event. The monitoring period ran from 10 May to 1 November.

At that time, Medsafe received one report of pancreatitis with the interleukin inhibitor tocilizumab, a drug that Roche sells as Actemra. There were no reports of pancreatitis related to the other approved interleukin inhibitors. The finding led Medsafe to work with Roche to update the datasheet for Actemra to include pancreatitis as a postmarket adverse reaction.

“However, there is insufficient evidence to confirm a risk of pancreatitis as a class effect for interleukin inhibitors. No further action is required at this time. The benefit-risk balance for interleukin inhibitors remains positive,” Medsafe wrote.

Medsafe Notice

ResMed updates Australian safety information for PAP masks in light of magnet risk

The medical device company ResMed is updating the Australian safety information and warnings for some positive airway pressure (PAP) masks to address the risk that magnets in devices will interfere with other medical technologies.

Certain PAP masks sold by ResMed and its main competitor, Philips, feature magnets to hold the devices in place. In September 2022, Philips issued a recall notice in the United States about the potential for magnets in its masks to “affect the functioning of or cause movement of certain implanted metallic medical devices.” The notice applied to more than 17 million masks.

The magnets in 12 products in ResMed’s AirFit and AirTouch lines have triggered a regulatory notice in Australia. TGA published the notice to share details of ResMed’s updated safety information and warnings. The changes apply to people with active medical implants such as pacemakers and metallic objects, including stents.

“The risk is that the magnetic field may cause active implantable devices to malfunction or result in movement of other implantable devices which has the potential to lead to serious injury or death,” TGA wrote.

If a user of the masks, or one of their household members or caregivers, has one of the implants, they should keep the magnets at least 15 cm away from the active or metallic device and ask ResMed about using an alternative mask. Users without access to alternative masks should talk to their physician.

TGA Notice

Singapore’s HSA issues alert after potent and banned substances tied to adverse events

Singapore’s Health Sciences Authority (HSA) issued an alert because two consumers suffered adverse effects after using products that contained potent or banned ingredients. The consumers bought the products online.

HSA’s notice applies to a cream marketed as a steroid-free treatment for eczema and a slimming product sold as herbal and natural. The person who used the eczema cream had a skin reaction, leading HSA to test the product. HSA found arsenic, a toxic heavy metal, and betamethasone, a potent steroid, in the formulation.

The other investigation centered on a patient who experienced vomiting and headache after taking a slimming product. HSA found that the product contained the weight-loss medicine orlistat and the laxative sennosides. Tests of another supplement revealed that it contained the banned substances sibutramine and benzyl sibutramine, as well as an antidepressant and an antihistamine. In contrast, a “slimming pill” contained the banned substance sibutramine.

“Be wary of products that promise miraculous recovery from chronic medical conditions, or claim to ‘contain 100% all-natural herbs/ingredients’ or ‘has no side effects,’” HSA wrote. “Such products may contain undeclared ingredients that may harm your health.”

HSA Notice

Asia-Pacific Roundup: Australia’s TGA adds adverse event search feature in response to feedback

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