hen Reena, a 45-year-old from southern India, picked up her new prescription for hypertension, she encountered something that is all too common: an accordion-folded piece of paper buried in the medicine box. Printed in small English text, packed with unfamiliar medical terms, and almost unreadable without glasses, the leaflet seemed more intimidating than helpful. Like many patients, she glanced at it briefly before sliding it back into the box, unread and unused.

That leaflet, however, was designed to be much more. It was a Patient Information Leaflet, or PIL—a document intended to protect Reena by explaining:

• What does the medicine do?
• How do I use it?
• What side effects should I expect? and
• What should I do in an emergency?

Unfortunately, her relative unfamiliarity with English as a second language and the leaflet’s use of complex English medical terminology made it practically inaccessible to her—just as it is for millions of patients around the world. For example:

• Samuel (Nigeria): Took antibiotics incorrectly because the leaflet wasn’t in his language.
• Elena (Italy): Stopped her antidepressant due to a side effect she didn’t expect—because it was buried in the text.
• Peter (UK): Was hospitalized after following outdated dosage instructions.
• Amina (Egypt): Couldn’t open or hold the leaflet due to Parkinson’s disease.

Also referred to as medicine labeling, PILs are vital tools designed to inform and empower patients regarding the safe and effective use of medicinal products. However, in their current form, PILs often fall short of achieving their intended purpose, particularly in terms of accessibility, usability, and timely dissemination of safety information. With growing global emphasis on patient-centric care and digital transformation, there is an urgent need to revisit how medicine information is delivered to the end user. This article explores the regulatory underpinnings and limitations of the traditional PIL format, and proposes a forward-looking, digital alternative using QR code-enabled audiovisual materials.

The Patient Information Leaflet (PIL), while essential in concept, has remained largely unchanged in execution for decades. It is mandated by many regulatory authorities as a cornerstone of safe medicine use. The European Medicines Agency (EMA), under Article 62 of Directive 2001/83/EC, permits the inclusion of QR codes on packaging to enhance patient access to information. The US FDA supports the use of QR codes to link patients to Medication Guides and safety updates. The World Health Organization (WHO) encourages the adoption of digital health tools that improve access to essential medicine information. In India, Schedule D (II), Section 6 of the Drugs and Cosmetics Act, 1940 and Rules, 1945 outlines the required structure and content of package inserts.

Despite these frameworks, the way we deliver this information has not kept pace with the digital transformation of healthcare or the evolving expectations of today’s connected patients.

Often, PILs are written in technical jargon that serves compliance rather than comprehension. Fonts are small, layouts are dense, and translations are limited. Even in countries with high literacy rates, many patients discard the leaflet or rely solely on what they recall from the pharmacist’s brief explanation. Worse still, in countries where medicines are dispensed without boxes, such as tablets cut and wrapped in a strip, the leaflet is often never seen at all.

There’s also a question of PIL information being current. When safety updates are issued, such as when a rare side effect is discovered or a new usage instruction is needed, it can take months for the updated leaflet to make its way into circulation. By then, patient safety may already be at risk.

All this raises a simple but critical question: Are we communicating the best way we can?

A Digital Alternative: The Power of the Scan

Imagine a different experience.

Instead of unfolding a paper insert, Reena sees a clear, prominent QR code printed directly on the medicine strip. She scans it on a smartphone. Instantly, a video plays in Tamil (her mother tongue), with clear visuals and a calm voice explaining what the medicine is for, how to take it, what side effects to watch for, and what to do if something goes wrong.

It is more than a translation: It is visual storytelling. It includes animations that illustrate how the drug works in the body. It offers subtitle options, voiceovers in multiple languages, and even the ability to slow down playback for older adults. The same QR code also links to other resources, such as safety updates, the manufacturer’s helpline, or even a message encouraging patients to speak with their physician.

This is not futuristic science fiction. The technology is already here and widely accessible. Most patients today own or have access to a smartphone. QR codes are familiar. Videos can be hosted securely and updated in real time. In fact, several organizations have already begun testing this approach. For instance, Public Health England used QR codes to share patient information leaflets digitally during the COVID-19 pandemic, reducing contamination risks and improving access to updated material. Similarly, digital health initiatives in countries like Myanmar leveraged QR codes to provide health updates and medication guidance via smartphones. For patients with low literacy or visual impairments, the ability to hear and see the information can make a significant difference in comprehension and safety. Additionally, a comprehensive 2024 review published by the Human Factors and Ergonomics Society analyzed 30 studies and found that QR codes significantly improved patient engagement, medication safety, and communication between providers and patients.

Beyond patient comprehension, this shift could deliver something equally profound: a new tool for pharmacovigilance.

When this type of educational content is hosted on a public platform—whether on a company’s website, app, or even on YouTube—it opens up new avenues for listening AND interaction. Patients begin to comment:

These are more than questions: They are data points from real-world signals that, when monitored responsibly, can support post-marketing safety surveillance. Pharmacovigilance, long reliant on spontaneous reporting, could now receive insights straight from the voices of patients.

Is the Regulatory Landscape Ready?

Encouragingly, yes.

As already stated above, several major regulators have long supported innovations that increase access to medicine information in local languages.

While printed leaflets remain mandatory in most regions, there is no reason digital versions cannot complement and extend their reach. Several pilot programs in both developed and developing nations are already testing QR-enabled medicine packs with positive results.

This is not merely about regulatory alignment. It is about serving patients better—faster, more affordably, and more meaningfully.

The Environmental and Operational Edge

Digital PILs bring a secondary benefit that’s no less important: sustainability.

By eliminating the need for physical reprints with every update, companies can reduce waste. Packaging becomes lighter, logistics more streamlined. The environmental savings may be small per product but exponential on a larger scale. For organizations committed to climate-conscious operations and ethical accountability through net-zero ambitions and ESG (environmental, social, and governance) reporting, this digital shift would directly support their environmental and governance goals.

Moreover, the cost of designing a high-quality digital video in multiple languages is often less than the recurring cost of printing and distributing paper PILs over a product’s lifecycle.

A Practical Path Forward

Transitioning to digital PILs need not be abrupt or disruptive. Marketing Authorization Holders can begin by:

• Creating short, validated audiovisual materials in key languages
• Printing QR codes on both primary and secondary packaging
• Hosting content on secure, accessible platforms
• Working with regulators to approve supplementary digital formats
• Monitoring usage data and feedback to refine and improve content.

Importantly, patients must be involved in the design of the digital PILs. Videos should be user-tested for clarity, simplicity, and cultural appropriateness. Healthcare professionals can also be engaged to offer feedback from the frontlines and promote digital PILs.

Rewriting the Future

Providing patient information is not just a regulatory box to check—it is a lifeline. It is the bridge between a prescription and its proper use, between a side effect and timely help, between confusion and confidence.

Modernizing how we present this information does more than improve compliance. It empowers lives. It gives people like Reena the clarity they deserve. And it builds toward a future where no one is left to guess how to use their own medicine.

Let us move from a folded piece of paper to a dynamic, inclusive experience that writes the next chapter of patient safety—one scan at a time.