Electronic Product Information (ePI) – digitalising medicine information for patients

To ensure patients and healthcare professionals (HCPs) have the information they need to take or prescribe medicines safely and effectively, all medicine packs are required to include a patient information leaflet (PIL).

Electronic Product Information (ePI) – the electronic version of the PIL – has the potential to transform the way product information is made available, and benefit patients, healthcare systems and the planet.¹

How? Well, ePI enables patients, carers and HCPs to access information electronically online, by scanning a code on a pack, and avoids the need for a paper leaflet. ePI is a digital-first solution that exemplifies our commitment to delivering more sustainable science – for the health of people, society and the planet.

Easier access to information on medicines

The use of digital technologies in healthcare is already widespread², and represents a significant opportunity to improve the delivery of patient care and health literacy. The transition to ePI enables faster access to the latest product information, potentially improving patient safety. ePI also enables improved accessibility to information on medicines for patients, carers and healthcare professionals (HCPs), by offering adaptable font sizes, multiple languages and searchable content. For those with audio or visual impairments, the opportunity to integrate ePI with existing accessibility software to ensure they can access the information is a huge benefit.

Accelerating medicine availability

By avoiding the need to produce a pack with a printed leaflet, transitioning to digital information can accelerate bringing new medicines to patients following their approval. For example, for recent launches in Singapore, new medicines were brought to patients on average up to three months earlier.³ The transition to ePI can also reduce time needed to develop, and continuously update, printed leaflets with each medicine pack, ensuring patients always have access to the most up-to-date information about their medicines.

Environmental sustainability

There are also environmental benefits to the digital transition. Every year, approximately 100 billion product information leaflets are printed worldwide¹, and billions are discarded without being read. We estimate that by transitioning to ePI across all of our medicines, we could potentially save 500,000 trees, 50,000 tonnes of carbon dioxide (CO2) equivalent and 1.6 billion liters of water per year.⁴ Moreover, a global transition to ePI could significantly reduce the environmental footprint of medicine supply chains across industry, potentially reducing CO2 equivalent emissions by 3.3 million tonnes annually.⁵

Our ePI ambition in practice

We aim to introduce ePI across all our medicines and in all markets, while ensuring flexibility to enable access to product information through alternative solutions where patients need them.

Our introduction of ePI, which is already underway across many countries, is dependent upon local regulations as well as other factors. Some countries require paper formats to co-exist alongside digital information for a period of time, while others already allow for a fully digitalised platform.

• Australia: All of our oral and non-parenteral products have transitioned to ePI and pharmacists provide support for patients who still require a paper Product Information (PI) leaflet. Discussions are underway on implementing ePI for injectables administered by physicians.
  
  
• Japan: We completed our transition to ePI for all our medicines at the end of 2022, enabling our manufacturing site in Maihara to save 30 million sheets of paper over one year⁶, well ahead of the Pharmaceuticals and Medical Devices Agency (PMDA) transition deadline of mid-2023.
  
  
• Baltics: A successful pilot in which PI was hosted on the Health Authority website has been extended for a further three years. Work is now underway to expand the implementation of ePI across a broader range of products, while wider discussions continue across the EU.
  
  
• Canada: With support from Health Canada and in alignment with their requirements, we have introduced phased ePI pilots for products across our therapy areas, with further expansion of the programme underway.
  
  
• Portugal: We launched a pilot in 2023 for hospital products only. There are plans for the pilot to expand to a broader range of hospital products.
  
  
• Singapore: We have transitioned around 70% of the volume of our medicines to ePI, where a QR code provides access to a digital platform. The transition continues for other medicines and from 2024, ePI is now hosted on an AstraZeneca digital portal. This progress is in line with the e-labelling guidance by the Health Sciences Authority (HSA) alongside its goal of establishing a “Smart Nation” with voluntary e-labels.
  
  
• Spain: In 2023, an initial ePI pilot was launched for hospital-use medicines. Discussions are underway to extend the pilot and explore the implementation of a hybrid model across all medicines (adding a QR code and keeping the paper leaflet).

Supporting the transition to ePI

To unlock an equitable transition to ePI, we’re working with governments, regulators, HCPs and patients to address challenges and maximise the potential benefits of ePI across our markets.

We're actively collaborating with pharmacies, patients, and healthcare practitioners to shape our strategy to ensure no patient is left behind. In Sweden for example, we ran a patient survey to collect insights on patient preferences for ePI, and are implementing these findings into our work moving forward.

We're also ensuring transparent and sector-wide engagement by fostering collaboration with regulatory bodies and industry partners. For example, in Brazil , we lead the Trade Association Interfarma alongside Sanofi, through which we are partnering with local health authority ANVISA to facilitate the transition to ePI across the country.

In the future, as technical capabilities evolve, enhanced versions of ePI could be integrated alongside other digital patient information systems to potentially bring even greater benefits to patients. Building a solid foundation for the transition to ePI today, will enable us to maximise sustainable science benefits of the digital transition.