Calls for online register to raise drug reaction reporting

Could a new digital reporting tool help tackle under-reporting of adverse drug reactions (ADRs)?
 
A team of researchers from the University of South Australia (UniSA) believe so, launching a study exploring patient and healthcare professionals’ views on the development of a tool to improve patient ADR reporting to the Therapeutic Goods Administration (TGA).
 
This comes following recent findings from a separate UniSA study showing that of the three quarters of Australians who have experienced an ADR to a medication, less than half have reported it to health authorities such as the TGA.
 
Dr Eyob Alemayehu Gebreyohannes is a research fellow at UniSA’s Quality Use of Medicines and Pharmacy Research Centre, and lead author of the new research aimed at gauging interest on development and use of a reporting tool.
 
He told newsGP there is a ‘huge gap’ of awareness regarding ADR reporting by the public or consumers in general, which his research team is hoping to fill.
 
‘This will be a good opportunity for GPs to educate about reporting to not only other healthcare professionals, but also reporting it to the regulators,’ Dr Gebreyohannes said.
 
‘We already know that adverse drug events are under-reported in Australia as well as globally, so what we are doing as part of a larger project, is working on a digital tool or platform to help improve the reporting rate.’
 
As part of that larger project, the team conducted a series of interviews, focus groups, and co-design workshops with 39 participants, comprising of patients (54%), healthcare professionals including GPs, pharmacists and nurses (41%), and the TGA (5%).
 
‘We’ve gathered insight to identify whether they support the development of the consumer-focused digital tool to report adverse drug events to the TGA,’ Dr Gebreyohannes said.
 
‘And what we found is this is supported by all key stakeholder groups, including GPs.’
 
Results related to ADR reporting included areas of difficulty recognising ADRs and health literacy, awareness and visibility, professionals’ views on patient reporting, benefit to the reporter, identifying those worth reporting, and concern about reporting.
 
The previous UniSA study found 39% of people did not think their ADR was serious enough to report, despite more than half knowing they could.
 
For the new study, surveyed patient participants reported varying perspectives toward an automated submission of reports to their GP.
 
While some proposed that crucial information should be automatically forwarded to their GP, others viewed this as a potential obstacle to reporting ADRs.
 
For example, one participant said, ‘critical information should go to the treating GP or specialist, so the person who’s having the side effects can have a conversation that’s informed and make sure there’s not something missing’.
 
Another participant felt that ‘not every side effect is worth me reporting to my GP, so I feel like an automatic report would be really unnecessary, and that’s my choice … If I opened the app and said this report would automatically generate a report to your GP, I would just not do it’.
 
So, could the new tool help GPs?
 
Bond University Professor of General Practice and RACGP Expert Committee – Quality Care Chair Mark Morgan, believes the proposed model would make it easier to report ADRs.
 
‘It is an informative study about patient and health provider attitudes to digital self-reporting of ADR to the TGA … with some interesting ideas about how to build confidence and trust in the system,’ he told newsGP.
 
‘My own preference would be for passive automated de-identified monitoring for ADRs in addition to reporting systems. I would like to see primary care data automatically analysed for events occurring after starting medications.
 
‘On a large enough scale, we would be able to pick up rare and common adverse events without relying on patients or doctors to actively make reports.’
 
Professor Morgan previously pointed out that less onus should be placed on doctors to report, as every action ‘takes away another action that might be more important’.
 
Meanwhile, Dr Gebreyohannes said the ‘crucial role’ of GPs in educating patients about reporting ADRs was discussed during their engagement with GPs and other stakeholders.
 
‘GPs can help educate patients and inform them there is a direct reporting system to the TGA,’ he said.
 
‘It should be important for GPs to educate patients about why we need to report to the regulators, the reasons for reporting, how they can make this report to the TGA, and what they expect after reporting.’
 
Study participants also highlighted the value of endorsements from government and professional institutions such as general practices and pharmacies, specifically the inclusion of official logos of the institutes and direct links from official government websites, as a means to ‘bolster public trust in utilising a digital platform’ for reporting ADRs.
 
With the first phase of the project complete, the second is to use the survey data to identify the key elements in designing the tool and where things should be addressed to ensure implementation.
 
Dr Gebreyohannes said this is currently at the design stage with a prototype expected within a year.
 
‘Once we have that, with the help of GPs, consumers and other key stakeholder groups, we’ll work to ensure it’s something that is easy to use and that collects important variables that helps the TGA to work on safety information on medicine,’ he said.
 
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