Patients feel it first: Strengthening medicine safety through patient reporting

Most people will take medicines at some point in their lives, and older people are more likely to take several at once. Each year, our pharmacy team at Adelaide University, Australia, is invited to give public talks on medicine safety, many of them hosted by groups for older adults like the University of the Third Age (U3A): A national, community-based network for older adults.

When the conversation turns to side effects, we hear the same story every year. People describe experiencing adverse drug reactions (ADRs) but never report them, asking: ‘Why weren’t we told to report them?’ and ‘Isn’t there a simpler way to report side effects?’

These questions cut to the heart of medicine safety. Patients are the first to feel the effects of medicines, living with them day to day. Minor symptoms – fatigue, dizziness, palpitations, mood changes – can be the earliest warning signs that a medicine is not working as expected. Reported and collected, these experiences reveal patterns that can trigger investigation and timely action. Ignored or unreported, critical safety information can remain hidden for years. However, patients lack the knowledge that reporting systems even exist, let alone find them easy to navigate if they have a side effect to report.

For example, in 2018, Australia’s regulatory authority, known as the Therapeutic Goods Administration (TGA), introduced the Black Triangle Scheme to prompt reporting for newly approved medicines and medicines used in new ways. Medicines included in the scheme carry a black triangle symbol (▼) in their product and consumer medicine information materials. Our unpublished research found that only half of healthcare professionals – and just one in ten consumers – knew about the scheme. Participants said the symbol was often overlooked due to its design and placement within medicine leaflets. Once explained, most recognised its value, highlighting that the problem is not a willingness to report, but knowing when and how to do so.

Even with multiple reporting options, such as a free pharmacist-staffed phone line and an online adverse event management system, awareness and overall reporting rates remain low. Campaigns and workshops help, but their effects fade over time. Availability alone does not create use. What is needed is a system that makes reporting an expected, routine part of taking medicines.

Our recent work has focused on addressing this gap using a consumer-centred digital approach to create a reporting platform for patients that will fit naturally into everyday healthcare. Over the past three years, our international research team from Australia, the Netherlands, the United Kingdom, and the United States has worked with consumers, health professionals, and medicine regulators to understand what would make ADR reporting easier, more relevant, and more likely to happen.

Using this knowledge, as well as interviews, focus groups, and co-design workshops, we, together with the TGA, worked with consumers to shape every aspect of the platform – from language and layout, to colours, icons, and font size. The result is ReMedi, a free, web-based ADR reporting platform designed with and for the patient, which complements the Australian pharmacovigilance landscape and aligns with TGA reporting pathways.

ReMedi is specifically designed to directly support medicine users – the consumers – allowing them to report ADRs to health professionals and the TGA. Preference testing with 200 consumers informed version 1.0, to be tested in South Australia this year, with a further 800 consumers to be recruited through pharmacies and primary care clinics. In the long term, the goal is to embed ReMedi into routine care, introduced at the point of prescribing or dispensing, and reinforced through visible prompts in pharmacies and clinics, for example, using posters, dispensing labels, and digital links.

ReMedi is also designed to support consumers beyond reporting. At present, users can generate and download a PDF report, but there is no built-in option to share it directly with their healthcare providers. A future update will incorporate seamless in-system sharing.

Our aim is simple: make ADR reporting a normal part of everyday medicine use, not an optional extra.

Patients’ experiences are the first warning signs that something is wrong, but alone, each observation can be easily overlooked. However, when promptly collected, analysed, and acted upon, these individual experiences signal the path to safer medicines, turning personal encounters into a protective force for all.