Alexandra Coutinho
Communications Officer and Editor-in-Chief, Uppsala Reports, UMC
While underreporting remains a persistent global challenge, innovative approaches are showing promise in different regions
While medicines and vaccines help treat, manage, and prevent disease, their clear benefits come with the risk of experiencing adverse reactions. Harm from medication use is one of the top 10 causes of death in the developed world. In Europe, recent studies estimate that it accounts for 5% of hospital admissions and is the fifth-leading cause of hospital deaths. In Europe, a 2012 European Commission report estimated that it costs the region around EUR 79 billion annually.
The above statistics emphasise the role of pharmacovigilance in ensuring that medicines and vaccines are safe. However, pharmacovigilance depends heavily on voluntary adverse event reporting to collect safety data, but this method is limited by significant underreporting. Uppsala Monitoring Centre recommends that a healthy national pharmacovigilance system should receive 200 reports of medication-related harm per 1 million inhabitants annually, yet many countries still fall short of this goal. In fact, global historical data suggest that only 2-4% of non-serious cases and 10% of serious cases are reported by healthcare professionals every year.
Underreporting remains a formidable challenge to global pharmacovigilance despite efforts to address the issue, as evidenced by over four decades of research examining its persistence. This body of research reveals a complex interplay of factors that requires comprehensive, multi-level interventions rather than isolated solutions.
Several factors contribute to the persistence of underreporting: reporter behaviours, attitudes and knowledge, the complexity of reporting procedures and access to reporting systems, and social and cultural barriers.
A 1976 landmark study by the pioneer of the Yellow Card scheme, Bill Inman, proposed a model that characterised behaviours affecting reporting by healthcare professionals into seven groups, the so-called “seven deadly sins”. These were ignorance (“I am unsure how to report”), diffidence (“I may appear foolish about reporting a suspected adverse reaction”), fear (“I may expose myself to legal liability by reporting”), lethargy (“I am too busy to report”), guilt (“I am reluctant to admit I may have caused harm”), ambition (“I would rather collect cases and publish them”) and complacency (“Only safe drugs are marketed”).
The original model remains relevant even 50 years later, though later studies have identified ignorance and lethargy as the deadliest sins. These are exacerbated by complex reporting procedures and systems, as well as the culture and perceived role of healthcare professionals in society, which varies from country to country.
Similarly, patient reporting suffers due to a lack of knowledge about the reporting system: how to report, what to report, and to whom, as well as misconceptions about adverse events (such as that they are expected consequences of taking medicines, or that reporting them will label the patient as “difficult” in the eyes of their doctors). Many patients also face technological barriers, such as limited internet access or digital literacy, which makes it difficult to use online reporting forms and websites.
In Uganda, Makerere University researcher Henry Zakumumpa found that HIV patients deliberately underreported serious adverse reactions to the HIV drug dolutegravir, as they believed it to be the most effective HIV medication and worried they would be switched to a less effective alternative if they reported.
Instead of being discouraged by the challenge, some countries are finding practical ways to improve reporting. They're tailoring solutions to fit their own healthcare systems and regulations, focusing on the specific reasons why underreporting happens. These solutions vary in approach, from digital improvements to reporting systems, to ongoing education, better integration of reporting into clinical practice, and legislative measures. The impact of these incentives has been notable.
In Australia, a pilot project led by Professor Ronald Castelino and colleagues at the University of Sydney developed an automated adverse event reporting system integrated into electronic medical records (EMRs) at Blacktown Hospital. This innovation removed two major barriers – time and lack of incentive – by capturing adverse reactions during routine clinical documentation. The result was a dramatic increase in reports, from just 13 in 2021 to over 1,500 within three years. Plans are underway to expand this system statewide, with hopes that future EMR upgrades will embed automated reporting as standard practice.
“A phone app may improve ADR reporting temporarily, but it’s not going to be a sustainable option… taking it out of the clinician’s hands and tackling the time barrier was the best action”
Many countries are increasingly turning to device and app-based solutions to remove friction from the reporting process. Researcher Henry Zakumumpa points to Uganda as an example, where mobile and email based reporting was introduced to improve accessibility and patient engagement. These solutions are backed by patient training and peer-led models to help them recognise and report adverse reactions. Caregivers are also encouraged to report on behalf of patients, and hotlines advertised in hospitals and pharmacies offer additional avenues for public reporting. These efforts have led to a noticeable increase in the volume of reports submitted to the national pharmacovigilance centre, although challenges remain around the completeness and quality of the data received.
The results from Uganda’s efforts clearly demonstrate the impact of more accessible reporting. To this end, UMC, in collaboration with WHO, have developed a customisable web app, VigiMobile, to simplify and strengthen adverse event reporting globally. VigiMobile enables healthcare professionals and patients to submit reports directly from mobile devices, even in low-connectivity settings.
In West and Central African countries, existing public health infrastructure has been harnessed to both educate and make adverse event reporting more accessible to healthcare professionals and patients. “We leverage the disease surveillance programme to improve pharmacovigilance reporting. Disease surveillance focal persons at the district level, who regularly visit health workers to search for measles, polio and yellow fever cases, now also ask if any adverse events have been reported. This stimulates the system and reminds doctors to look out for adverse reactions,” says Edinam Agbenu, vaccine safety officer at the WHO Regional Office for Africa.
Legislation has also made a significant impact on reporting for both types of reporters. In Europe, pharmacovigilance legislation introduced in 2012 required countries to support direct patient reporting to national authorities through education and accessible tools like online platforms. Countries such as Lithuania, which had no patient reporting system prior to 2012, recorded the sharpest rise in submissions. The SCOPE Joint Action, a collaborative EU initiative, further boosted reporting through social media campaigns – one of which reached 2.3 million people and led to an 11% increase in reports in 2017.
Despite these advances, no single intervention can fully address the complex web of factors driving underreporting. Studies consistently show that multi-modal strategies combining education, system redesign, legislative support, and digital tools are most effective.
Education stands out as a cornerstone. Outreach workshops, training sessions, and reminder tools have been shown to increase reporting, though their effects often wane within six months. This underscores the need for consistent and repeated education, which is why campaigns like #MedSafetyWeek are so important.
Now in its 10th year, Medicines Safety Week has become a global platform for raising awareness, empowering patients, and reinforcing the importance of pharmacovigilance. By spotlighting different groups of reporters and demystifying the reporting process, it helps embed a culture of safety in clinical practice. Its annual recurrence ensures that pharmacovigilance remains top-of-mind – not just for one week, but throughout the year.
As we celebrate a decade of the #MedSafetyWeek campaign, it’s clear that the path forward lies in collaboration, innovation, and education. Underreporting may be a persistent challenge, but it is one that can be overcome with the right tools and commitment.
READ MORE:
“Beyond numbers: Quality in ADR reporting”, Drug Safety Matters podcast
“A week in the name of medicines safety – part 1”, Drug Safety Matters podcast
Alexandra Coutinho
Communications Officer and Editor-in-Chief, Uppsala Reports, UMC
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