Around the Globe: ASEAN

Accelerating Adoption of eLabeling in Singapore: One Company’s Journey
Anna Litsiou, Priti Shah
AstraZeneca UK
Lee Mei Liew, Pearle Liew, Sau Wei Wong
AstraZeneca Singapore
E

lectronic labeling (eLabeling hereafter), or the utilization of digital labels on packaging, is an example of digital transformation for medicinal products gaining international momentum.

eLabeling benefits both users and the environment. For patients, caregivers, and healthcare professionals (HCPs), timely communication of approved and accurate product information from a trusted source has the potential to build confidence.

Digital features like patient’s preferred language choice, utilization of structured information, and additional accessibility options could increase health literacy. Special features for the elderly and patients with specific needs which require enhanced audio or visual, zoom or text, components can potentially improve readership and support patient compliance significantly.

From the environmental perspective, eLabeling efforts enhance sustainability driven by waste elimination, traceability, and quicker label production while mitigating drug shortages.

Several international regulatory agencies, such as those of Australia, Japan, and Singapore, are well advanced in implementing eLabeling, while others are shaping the regulatory environment through pilots.

This article explores Singapore’s journey in implementing eLabeling for product information through a case study examining the factors contributing to one company’s success.

Singapore Implementation of eLabeling: Smart Nation Approach

Singapore has undergone a digital revolution and transformation through the launch and release of Smart Nation in November 2014. In 2019, Singapore’s Health Sciences Authority (HSA) embraced this Smart Nation ambition with their advanced proposal for eLabeling implementation for prescription (Rx) products, initially through a 20-month pilot trial project before full implementation in 2021. This pilot was a concerted effort of HSA, industry stakeholders, and HCPs. HSA and/or participating companies sought feedback from HCPs during the pilot trial.

This pilot focused on assessing the reliability and feasibility of disseminating accurate and updated electronic Product Information (ePI) in an efficient, timely, eco-friendly manner, while increasing understanding of the user experience, with an end goal of developing and releasing final guidelines and an implementation roadmap for eLabeling.

After receiving positive feedback on this pilot from the Singapore Association of Pharmaceutical Industries, industry stakeholders, and HCPs, HSA officially launched voluntary eLabeling for prescription (Rx) products only and published the first Guidance for Electronic Labelling for Therapeutic Products in 2021. This guidance focuses on eLabeling formats and accessibility recommendations and on ensuring that new product information updates are applied within 30 days from their approval.

In this voluntary initiative, companies could disseminate the approved product information in an electronic format via a machine-readable code (e.g., QR code) or URL (shortlink preferred) on the product carton, both linking to a secure, online third-party hosting platform. Distribution was possible with or without including printed paper copies in the product packs.

The platform hosting the approved product information must comply with local guidelines relating to advertisement and promotion of prescription products, ensuring the medicine’s safety and efficacy.

Roadmap to eLabeling Implementation: One Company’s Perspective

In 2017, prior to the introduction of this HSA eLabeling pilot trial, one global biopharmaceutical company embarked on its own project to become an early adopter of eLabeling in Singapore. Driven toward sustainability and enhancing the patient journey by enabling access to up-to-date, real-time prescribing information, eLabeling became a key strategic priority for this organization.

This organization identified five key areas (Figure 1) to enable their internal eLabeling pilot for the first set of products, which began in 2020. To date, more than 70% of the marketed products from five different manufacturing sites have successfully implemented eLabeling through this pilot in Singapore.

Example PROM assessment schedule for first 12 months of advanced cancer trial, as presented in the FDA draft guidance
Figure 1.

Local Legislation

Development of local legislation is essential to provide a clear operational expectation of the health authority’s requirements. As a result, an industry eLabeling working group was established to regularly engage with HSA. This working group provided the necessary momentum and partnership to co-create the local legislation and respective operating environment with HSA by incorporating the experience and post-implementation feedback after the pilot. The guidance provided sufficient detail to the regulatory framework and afforded flexibility to industry in its implementation. This early engagement enabled industry stakeholders to be an integral part of the solution towards eLabeling and accelerated our efforts towards eLabeling adoption—a ”win-win” for all.

Digital Readiness

The hosting platform was not on the health authority site. Selecting the hosting platform posed another major challenge for this organization. Such platforms can be hosted by either a company or a third party. In this instance, a third-party platform was chosen due to its availability. The company considered the cost, development, maintenance, ease of use, and readiness, as well as the GxP components vital to meeting both internal and external eLabeling requirements, of this platform. After this platform was validated and processes were established, the organization created, reviewed, and refined standard operating procedures to ensure GxP compliance.

The pilot system included processes for generating QR codes and for creating URLs and establishing the corresponding website. These features were key for the ePI platform’s readiness to allow timely accessibility to end users such as HCPs.

Governance

This pilot implementation involved many aspects and parties. Therefore, the project team conducted a robust impact assessment designed to implement the changes effectively, mitigate identified risks, and drive successful eLabeling adoption with cross-functional alignment.

Key impact assessments included regulatory and product impact assessment. The regulatory perspective primarily considered the ability to comply with ”must have” local requirements for eLabeling implementation. From the product perspective, manufacturing sites conducted feasibility tests on the products to ascertain whether packaging changes were required to accomodate ePI implementation. Internal processes were developed per each impact/risk assessment. This was arguably the most extensive part of this company’s eLabeling journey, particularly when/where there was no previous process to follow. Internal procedure development followed an iterative cycle across different products and was resource intensive.

The involvement of the local cross-functional team (regulatory, commercial, medical, and supply chain) was key to discuss, agree upon, and align with the product selection. Respective alignments and agreements between regional and global teams were also sought.

Manufacturing site collaboration was considered crucial for the success of this pilot because these sites were the enablers for the adoption of ePI on physical packs and packages. They also worked to ensure alignment with timing in the global supply chain for continuous product supply.

Other key discussion aspects included dosage forms, the number of products, and their impact on the supply in terms of time and minimizing the product shortage risk. All prescription products were eligible for this pilot, which demonstrates the flexibility of the pilot’s requirements.

Parallel discussions with commercial and medical teams also ensured that patients continued to receive their medicines without interruption throughout the pilot.

Manufacturing Site Readiness

Even though this pilot included a small number of products, manufacturing site readiness at a global and local level was key. Multiple discussions were held with manufacturing sites to determine production numbers, readiness, and feasibility. Artwork updates and packaging feasibility were assessed for the selected products using risk-assessment tools. Timelines were also part of the feasibility study and were discussed with operations and commercial functions. A plan for close follow-up and cross-functional communication was established for the target implementation and shipment. This applied locally and globally and ensured seamless supply and timely mitigation of risks.

Prescriber Readiness

Ahead of the pilot initiation, the company assessed HCPs’ preferences and readiness for eLabeling, considered a key link to patient access to product information, through a survey. Key survey findings incorporated in the pilot were: a) most HCPs supported the eLabeling initiative because it provides up-to-date product information and real-time access during treatment compared to the conventional method of receiving paper copies of product information in the packs; and b) QR code (quick response code) was the most preferred option to access this ePI.

When this pilot was initiated in 2020, the company disseminated external communication letters to HCPs prior to the distribution of products with ePI features. This early engagement with HCPs and continuous communication through this pilot enabled immediate feedback and accommodated adjustments, facilitating a more comprehensive and inclusive solution early in the project.

Key Recommendations

Through the experience from the development and implementation of the Singapore eLabeling pilot and its own successful implementation, the company makes these eLabeling implementation recommendations shown below:
Area
Recommendations
Regulatory Framework
  • Regulatory harmonization and common standards to support semi-/fully-structured ePI avoiding fragmentation and create legal certainty supporting digital opportunities amongst stakeholders
  • Policy advocacy strategy roadmap on evidence generation, leveraging available resources and support, and active participation through local trade association and consultation of draft guidance
  • Pilot utilization and adoption of phased approach to fine tune regulatory framework
Communication
  • Stakeholder mapping: Industry, patient organization, healthcare professionals and health authority
  • Regular and close communication with HA representatives, and relevant internal and external stakeholders as fundamental to the process
  • Clear communication and sector-wide education ensuring ePI becomes the trusted and accepted source of regulator approved information
  • Best practice sharing (leverage on the best practices, shape the local environment)
Implementation Strategy
  • Clear project management and execution road map
  • Collaboration of stakeholders
  • Address readiness and feasibility through surveys externally and internally
ePI System
  • A validated and secured hosting platform with QR generation, and landing website capabilities while user friendly
  • GXP compliance (e.g., change control management, risk assessment, trainings, documentation, etc.)
  • A single access point and direct access to the authorised Product Information from the (secondary) packaging using only one code to ensure clarity
  • Patient- and people-centric ePI implementation that drives an equitable solution
  • Multilingual and disabilities enabled.
Area – Regulatory Framework
Recommendations:
  • Regulatory harmonization and common standards to support semi-/fully-structured ePI avoiding fragmentation and create legal certainty supporting digital opportunities amongst stakeholders
  • Policy advocacy strategy roadmap on evidence generation, leveraging available resources and support, and active participation through local trade association and consultation of draft guidance
  • Pilot utilization and adoption of phased approach to fine tune regulatory framework
Area – Communication
Recommendations:
  • Stakeholder mapping: Industry, patient organization, healthcare professionals and health authority
  • Regular and close communication with HA representatives, and relevant internal and external stakeholders as fundamental to the process
  • Clear communication and sector-wide education ensuring ePI becomes the trusted and accepted source of regulator approved information
  • Best practice sharing (leverage on the best practices, shape the local environment)
Area – Implementation Strategy
Recommendations:
  • Clear project management and execution road map
  • Collaboration of stakeholders
  • Address readiness and feasibility through surveys externally and internally
Area – ePI System
Recommendations:
  • A validated and secured hosting platform with QR generation, and landing website capabilities while user friendly
  • GXP compliance (e.g., change control management, risk assessment, trainings, documentation, etc.)
  • A single access point and direct access to the authorised Product Information from the (secondary) packaging using only one code to ensure clarity
  • Patient- and people-centric ePI implementation that drives an equitable solution
  • Multilingual and disabilities enabled.
In summary, this company’s pilot in Singapore has shown that replacing paper PI with ePI can enable earlier treatment access, avoid product wastage and shortage, reduce the environmental footprint of the healthcare supply chain, and mitigate any unintended consequences of including paper PI in the packs. This can only be achieved in a flexible regulatory environment, through transformative pilot projects and a deliberate collaborative approach among all stakeholders.

From the environmental perspective, eLabeling enhances sustainability by eliminating product waste and enhancing product traceability and quicker label production while mitigating drug shortages. This Singapore eLabeling pilot initiative saves the annual consumption of 350 trees by eliminating the estimated 20 tons of paper needed to produce paper leaflets; it takes approximately 17 trees to produce one ton of paper. It has also inspired subsequent eLabeling pilots in company locations across several continents.

As part of overall digital innovation in healthcare development, eLabeling delivers patient-centric, transformative, and sustainable healthcare solutions, with a reduced carbon footprint, that have a positive impact on people, society, and the planet. Other advanced digital features can be further explored and developed to allow even better eLabeling user experiences. Embracing these pilots and digital transformation paves the way for the future.

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