Lost in fine print: how patient information leaflets are failing patients

One night in March 2025, Kate got a call from the hospital around 1 am to say her son was being moved from the ward into the intensive care unit. “[I thought] they were going to go, yeah, we just moved him as a precaution,” she says. “But they said: ‘We’re trying everything we can at this stage’.”

Her son Riley, aged 19 years, had gone into A&E earlier that day with bad stomach pain and vomiting after more than a week of feeling unwell with the flu. His housemate at university had pushed him to call 111, who told him to go to A&E. “We just thought he had norovirus,” Kate adds.

Within hours of Kate receiving the call, Riley’s heart rate had spiked, and he’d begun to hallucinate. By the time he was sedated and blue-lighted to the specialist liver unit at King’s College Hospital in London, his liver, kidneys and heart were failing. He was soon put at the top of the liver transplant list.

It was only when a security guard was sent to break into his university room — after he’d been placed into a medically induced coma — that the cause became clear: hepatotoxicity^​1​ owing to paracetamol overdose. On his bedside table were empty boxes of cold and flu tablets and paracetamol. Riley’s parents later learned he’d been taking both medicines throughout his illness, every two to four hours — “topping up” as he began to feel worse, without realising he was doubling his paracetamol intake.

Riley is one of around 100,000 people admitted to A&E in the UK each year with paracetamol overdose^​2​ — the leading cause of acute liver failure in the UK^​3​ — and among 50,000 people admitted to hospital.

What drives that number is something Giorgia De Paoli, a forensic toxicologist, pharmacist and lecturer at the University of Dundee, has been investigating for years alongside colleagues^​2​.

“The main factors are linked to education… and health literacy,” she says. “[People] have challenges when it comes to understanding health information. This could sometimes be linked to calculating the dosage […] don’t forget these are people in pain.”

De Paoli also highlights that many patients misinterpret 24-hour dosing limits, assuming that after midnight, a new day has started and they can take more medication, when the 24-hour limit actually runs from their last dose.

“I think the public widely perceive paracetamol as a safe medicine because of how accessible it is,” notes Puja Nathwani, prescribing infrastructure lead pharmacist for Brent Integrated Care Partnership.

“It has created a false sense of security. It is not unusual to see patients who are taking multiple over-the-counter products that contain paracetamol and essentially double dosing.”

For Riley, his parents believe he simply wasn’t in a fit state to take in all the information on either medicine box or understand the consequences of taking too much paracetamol because he was so ill. When you’re in pain, “your brain doesn’t function; you just want it to stop”, De Paoli says.

“This shouldn’t happen with a medicine that we should be using for its benefits.”

Do labels fall short?

Patients being unable to read or understand the information that comes with their medicines is clearly a safety risk. A 2023 report by the Kent Surrey Sussex Academic Health Science Network found that nearly one-third (32%, n=743) of patients fully understand the patient information leaflet (PIL) provided with their medicine, while over half (55%, n=1,124) reported issues with readability^​4​.

Leanne May, a community pharmacist and associate professor in pharmacy practice at Kingston University, believes there is a gap between medicine information being provided and that information doing its job. “What concerns me is that we often assume that because information has been provided, it has been understood,” she says.

“In reality, many people do not read PILs in full, may struggle to interpret the language used, or may not recognise the significance of safety warnings. This can be particularly important with paracetamol, which is widely available and generally perceived as safe, despite the serious consequences that can result from taking too much.”

Kate recognises this in Riley’s case. “The wording on [the packet] says ‘contains paracetamol,’” she says. “But what does that mean? Unless you know you can’t take two paracetamol doses together… it doesn’t actually tell you anything. I think that’s incredibly dangerous.”

Even though compliant with statutory requirements (see Box), May believes the presence of paracetamol itself isn’t always prominent enough on packaging for patients to immediately recognise, particularly in combination products where branding tends to focus on symptom relief.

“Patients often identify products by their intended use rather than their ingredients, so… paracetamol can be easily missed,” May says.

“The information patients need is often buried in dense text that can be difficult to understand, especially for people with learning disabilities, cognitive impairments, low health literacy, or anyone who is unwell, stressed or overwhelmed.”

For Ghalib Khan, founder and chief executive of Written Medicine, which makes information about prescribed medicines more accessible for patients with language and communication barriers, the issue runs deeper than any single label. “Medicines information is designed better for clinicians than it is for patients,” he says. “It often feels like one scientist writing for another scientist.”

Nathwani adds that labels should be regarded as a “critical patient safety intervention rather than simply a regulatory requirement,” especially when it comes to improving health literacy. The medicines Riley overdosed on carried exactly the warning and PIL that the regulations require.

However, information built to satisfy a regulator and a clinician may not be the same as information a 19-year-old can actually use. “When you’re really poorly… alone… and you have no idea what time or day it is, how can you be [safely] administering paracetamol or whatever you’re taking?” Kate says.

The case for going digital

There are efforts underway to improve PILs and the way patient information is presented. In March 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) launched its ‘Improving patient information’ project, working with stakeholders across the UK health system to identify what’s stopping medicines information being accessible, trusted and “fit for the future”.

As Smita Robinson, head of the product information quality unit at the MHRA, wrote in The Pharmaceutical Journal in July 2026, the regulator’s commissioned research found that while some patients still value paper leaflets, many want more “clear, practical guidance” that helps them make informed choices and use their medicine safely. PILs have been a legal requirement since 1999, but Robinson acknowledges that the safeguards haven’t been enough.

“Leaflets can be overwhelming, hard to navigate or simply not suited to the moment when a patient actually has a question,” she added.

Part of the case for going digital is timescales. Updating a paper leaflet can take six to nine months or longer, meaning a patient can be handed information that’s already out of date before they’ve opened the box. Malcolm Harrison, chief executive of the Company Chemists’ Association (CCA), has seen the consequences firsthand.

“We see quite a lot of medicines safety notices based around incorrect or outdated information on the PIL,” he tells The Pharmaceutical Journal. “Some require batch recalls. Whereas if it was… digital, you’d be able to just update it.”

In June 2026, one such case forced a recall of flucloxacillin capsules made by Flamingo Pharma UK, after some packs were found to contain the PIL for a different antibiotic entirely (i.e. amoxicillin). The capsules themselves were unaffected, but the packs had to be pulled from pharmacies regardless.

Running alongside the MHRA’s work is the CCA’s Medicines Supply Resilience Group, which was set up in 2024 to introduce electronic PILs (ePILs) as part of a wider push to strengthen the medicines supply chain. Its briefing argues moving to ePILs offers “considerable potential benefits” for patient safety, the supply chain and the environment, and aligns with the NHS ten-year plan’s shift from ‘analogue to digital’.

Going electronic, though, isn’t simply about moving the same block of text to a screen. “What we’re not talking about is just having a scan of a paper thing,” says Harrison. “We need to understand… what questions patients are going to have and how can we quickly… get the information they need.”

He argues that done properly, a digital leaflet could look nothing like its paper equivalent — accessed through an app, built around diagrams, images or short videos, rather than dense text. “In today’s modern age, that’s just not how people consume information,” Harrison adds.

Screen limitations

May also cautions against assuming this solves the problem. Moving information “from paper to screen will not in itself prevent harm,” she says, particularly as digital accessibility assumes both digital access and literacy. A 2025 report by PAGB^​5​, which is the trade body for consumer healthcare products, found that 56% of people with no formal qualifications feel confident to judge whether health information online is accurate, compared with 72% of those educated to undergraduate level.

The divide is sharper still for people with a learning disability. Lindsey Allen, programme lead for health inequalities at the British Institute of Learning Disabilities (BILD), says that “the move towards ePILs could create significant barriers”, highlighting that this group is “known to experience digital exclusion”.

Kate Brackley, learning disability advisor at BILD, agrees: “Due to my eye problems, it’s difficult for me to see the label on medication. What would really help me would be an easy read information sheet… printed out — not on the computer or my phone.”

Harrison shares this concern, even while making the case for ePILs. “Having the information on a digital platform opens up a lot of avenues of how it can be tailored to accommodate different people’s needs,” he continues.

It’s a balance worth making for around 1.5 million people in the UK with a learning disability^​6​, who are also more likely to have associated health conditions such as epilepsy, obesity or mental health problems^​7​. “These people are more likely to use healthcare services than the general population,” Khan says, whose own son has Down’s syndrome. “Yet these patients are the least served.”

“Poorly understood medicines information can contribute to medication errors, non-adherence and avoidable harm,” Khan adds. The results of a 2022 study revealed that adverse drug reactions directly caused or contributed to 16.5% of medical admissions examined over one month, though it didn’t look at how much of that was down to unclear information specifically^​8​.

Khan’s benchmark for what should change is deliberately simple. “The average reading age in the UK is eight or nine — but patient information is commonly written at too high a level. The essential instruction should be clear enough for a five-year-old to understand it,” he says.  

That belief led Khan to set up Written Medicine 14 years ago. The organisation produces multilingual and pictogram-supported pharmacy labels for all medicines, and has developed QR-linked digital content for around 400 medicines.

For the hormone replacement therapy patch Evorel — for example — a QR code on the pharmacy label links to audio instructions and short illustrated or video guidance. Depending on the patient’s needs, the audio instructions can be provided in English or another language, which is something the ePILs project is also exploring.

Both Khan and May also believe the moment of dispensing matters as much as the format. “Small interventions can make a difference,” May notes. “It only takes a few seconds to give the right advice.”

Beyond the leaflet

Khan’s Written Medicine model shows what’s possible. While both May and Nathwani welcome the MHRA and CCA’s work, Nathwani believes that “change needs to be system-wide” with coordinated leadership focused on clearer front-of-pack warnings, visual cues to flag duplicate ingredients, public education on paracetamol in combination medicines and closer scrutiny of how combination products are displayed at retail.

May adds that, for people with learning disabilities, accessibility to information “needs to be built in from the outset, rather than adapted as an afterthought”.

Asked what comes next for the ePILs project, Harrison says they are working closely with the MHRA “to enhance the work they’re doing”, adding that “the next step is […] to see where the opportunities are and if there are any gaps, what we can do to try and fill them”.

Whether these projects succeed rests on whether the information they design reaches patients in a useful state. Riley’s liver recovered without a transplant, and he’s back working at his local pub and “loving life,” as Kate puts it — but it took weeks for him to learn how to walk, breathe and swallow properly again. The family are fundraising for the hospital that saved him, taking on the 50k Gower Peninsula Ultra Challenge and hoping to raise awareness of paracetamol safety along the way. “It’s not about scaremongering… it’s about educating people,” says Kate. “You can still take it — just be sensible and make sure you know what you’re doing with it.”

“People have to remember that it’s medication at the end of the day,” adds Riley’s stepdad, Chris. “The difficulty is making people aware of how it becomes dangerous rather than the fact that it is. Hiding it in a little bit of paper inside the pamphlet is close to useless.”