E-labeling to improve patient safety
Electronic labeling or e-labeling (also known as digital labeling) can improve patient safety. Medical product information is designed with the intent to ensure prescription and nonprescription healthcare products are used in an effective and safe manner. This information is a culmination of clinical development data and post-marketing lessons and data, translated into descriptive text for healthcare professionals (HCPs) and in some cases specifically for the patient. It plays a pivotal role in ensuring patient’s understanding of their treatments while also supporting HCPs in their decision-making.
To make this information even more effective, new, digital-enabled tools for delivery of labeling that facilitate access, understanding, and usability are key components in enabling more effective use of available treatments and helping raise overall health literacy. E-labeling is the dissemination of approved product information for medicinal products including those in a dynamic digital format.
E-labeling makes information readily accessible to HCPs, patients, and regulatory agencies. This accessibility can improve patient safety by providing accurate and up-to-date information about medications. HCPs can use this information to identify and mitigate potential risks associated with the use of medicines, vaccines, and diagnostics, ultimately improving patient outcomes.
Aside from improving patient safety, e-labeling offers numerous benefits, including improved accessibility, real-time updates on product information, cost savings, improved compliance with regulatory requirements, enhanced patient engagement, and environmental sustainability.
The global biopharmaceutical industry’s commitment to innovation and patient safety is aligned with the implementation of pioneering solutions to improve speed in information sharing and educating patients and HCPs. Not only is this a response to the need for more interconnectivity between stakeholders in the health systems, but also a way of simplifying and accelerating regulatory information management and process while helping to reach environmental sustainability goals.
In a paper published by Richard Simon Binos et al. entitled “Advancements in regulatory agility, regional collaboration, and digital transformation: Insights from APAC,” it was found that eight out 12 Asia-Pacific countries have been implementing e-labeling. These countries are Japan, Singapore, Taiwan, Thailand, China, Indonesia, Malaysia, and South Korea. The Philippines can also pilot its implementation as a joint effort by the Philippine Food and Drug Administration and the biopharmaceutical industry.
The complexity of industry’s globalized supply chains had also been put to the test during the COVID-19 pandemic, which provided a case study on how e-labeling could be leveraged. E-labeling will increasingly play a role in facilitating fast deployment of product information and enhancing health literacy and patient adherence. One of the most important advantages offered by e-labeling is accessibility to the most up-to-date product information approved and validated by the local national regulatory agency virtually in real time and in the corresponding local language. Alerts about major changes to the product information can be added and highlighted, raising awareness and protecting patients more effectively. This will go a long way in protecting patient safety.
E-labeling promotes better patient and HCP understanding. Poor understanding and adherence to product information has been directly linked to poor health outcomes and increased costs for already burdened healthcare systems. It can be used to help improve patient understanding, ultimately leading to increased adherence and better use of the medicines, vaccines, and diagnostics.
As e-labeling is dynamic, in the sense that it can be adjusted to each user’s preference using authoritative information, it could enhance health literacy by changing how a patient is able to interact with product information through a variety of ways.
E-labeling ensures the availability of both HCP and patient-type-centric information. It provides a wide range of regulatory-approved translations (where available), in the language preferred by the patient or HCP. It can leverage new formats such as audio, and/or visual. Patients already consult a significant amount of health-related information online, using different kinds of electronic devices. E-labeling provides patients the opportunity of doing so through a trusted channel.
Meanwhile, e-labeling provides the ability to search label content to easily find information, especially relevant for the partially sighted or patients with any sort of visual impairment. Font size can be customized to improve readability. E-labeling makes it easy to share approved information with wider audiences. It also facilitates sharing of comprehensible information between patients, their families, and caregivers.
E-labeling can also strengthen health systems by improving supply chain resilience and efficiency. Platforms that allow for streamlined ways of sharing new product information will lead to an acceleration and simplification of processes for post-approval changes to label information. In addition, it offers the opportunity to share labeling between countries when appropriate. This will have a positive effect in better managing drug shortages and further strengthening global pharmaceutical supply chains. The use of e-labeling also cuts out a substantial lead time for leaflet printing and packaging, granting patient faster access to new medicines, vaccines, and diagnostics.
As illustrated by the COVID-19 pandemic, labeling flexibility is particularly important when increased demand, disruptions in transport, and other factors impact the normal flow of products. With this, e-labeling can have a positive impact on the availability of up-to-date national regulatory agency-approved product information that will result in improved health outcomes for the people.
Teodoro B. Padilla is the executive director of Pharmaceutical and Healthcare Association of the Philippines (PHAP). PHAP represents the biopharmaceutical medicines and vaccines industry in the country. Its members are in the forefront of research and development efforts for COVID-19 and other diseases that affect Filipinos.
