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Patients under-reporting adverse drug reactions: Study


Morgan Liotta


20/09/2024 2:11:54 PM

Despite many Australians knowing they can report ADRs, notification rates are low, especially when using digital reporting tools.

Woman looking at phone while holding medication
Although more than half of survey respondents knew they could report an adverse drug reaction, 39% did not think it was serious enough to report.

Around 75% of Australians have experienced an adverse drug reaction (ADR) to a medication, but less than half have reported it to health authorities.
 
That is according to fresh research from the University of South Australia (UniSA), published in the European Journal of Clinical Pharmacology.
 
Surveying 544 Australian adults taking one or more medicines, the study aims to better understand the current knowledge and willingness of reporting ADRs, and the reasons for reporting or not, particularly since the introduction of digital reporting technologies.
 
It found only 36% of those who experienced an ADR reported it, despite 58% of respondents knowing that they could report these to either the Therapeutic Goods Administration (TGA), state or territory government health departments, or healthcare professionals.
 
The main reason (39%) for not reporting was believing the ADR was not serious enough.
 
Professor Mark Morgan, Chair of the RACGP Expert Committee – Quality Care, told newsGP there are multiple methods of collecting ADR information, but any safety system that depends on event reporting by patients or doctors ‘runs the risk’ of missing ADRs.
 
‘Easier methods of reporting can certainly help, [for example], some of the recent innovations that send a text message following immunisation to ask whether or not there have been adverse effects are helpful,’ Professor Morgan said.
 
‘Adverse reactions from medicines might be harder to recognise because they take time to develop and may also not be easy to attribute to a particular medicine. This is why automated systems that use big data approaches to look for adverse changes in pathology results following initiation of a medicine should be piloted.’
 
And while Professor Morgan sees the value in digital reporting technologies, he said these should not place unnecessary onus on GPs and other healthcare professionals, whom already have a role in incorporating patient counselling about adverse reactions when prescribing and dispensing.
 
‘I hesitate [to suggest] that doctors should do more – every action by a doctor takes away another action that might be more important,’ he said.
 
‘The role of dispensing is meant to incorporate patient counselling about adverse reactions, but it is unclear how often the counselling at the time of dispensing happens.’
 
Among those who did report ADRs, 58% were unaware they could use digital tools, with the authors saying their findings highlight the need for greater awareness of digital self-reporting of ADRs.
 
Lead author Mohammed Dedefo, said this gap in knowledge is contributing to under-reporting, and potentially increased harm.
 
‘Strengthening the vigilance around medication-related harm is essential to monitor the safety of medicines in hospitals and other settings,’ he said.
 
The use of digital tools for ADR reporting helps regulatory and health authorities more closely assess specific medications to detect any negative patterns, according to the UniSA researchers, who are also developing NHMRC-funded digital tools to make it easier for patients to report ADRs and help reduce health costs.
 
It is estimated 2–4% of all hospital admissions in Australia each year are due to medication-related harm, costing the healthcare system $1.4 billion annually.
 
Developed by the TGA, Australia’s current reporting system may not be well known to most patients, the study authors suggest, and mainly used by healthcare professionals and pharmaceutical companies.
 
The UniSA survey questions introduced TGA reporting then asked if people were aware of this option for reporting.
 
‘I wonder if the responses would have been lower to an open unprompted question asking people to list where they thought you could report ADRs,’ Professor Morgan said.

Prof-Mark-Morgan-article.jpgIncorporating counselling about adverse reactions when prescribing medications should be routine for GPs, says Professor of General Practice, Mark Morgan.
 
Noting that international studies show that digital tools can double the incidence of ADR reporting, the authors say that integrating digital reporting options into widely used healthcare apps and patient portals would help to increase reporting rates.
 
Professor Morgan agrees there should be systems ‘to compare information internationally’ and ongoing safety monitoring of patients should be in place.
 
‘There is a need to use de-identified primary care data sets to monitor for possible side effects in the days, weeks and months after starting a new medication,’ he said.
 
‘De-identified general practice records can identify “reason for visit”, new diagnoses and recorded “reasons for cessation”.
 
‘Taken together, these data could form the basis of an automated post-marketing surveillance system to dovetail with convenient self-reported digital ADRs.
 
‘Automated post-marketing surveillance systems would certainly pick up on rare but devastating impacts. This is needed because the small numbers of people that new medicines are tested on in clinical trials means that rarer side effects will be missed.
 
‘Also, in the real-world use, outside of clinical trials, there are people with multimorbidity who might experience different ADRs.’
 
A large proportion of study survey respondents labelled a lack of awareness, privacy and security concerns as barriers to ADR reporting using digital tools. The authors therefore say that addressing these factors are ‘crucial’ to encourage the use of digital tools for ADR reporting.
 
‘Future research should focus on evaluating consumer interest in using digital tools for ADR reporting and assessing the impact of digital tools on the rate and quality of ADR reporting,’ they state.
 
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newsGP weekly poll On average, how many patients do not show up for their appointment at your general practice each week?

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