Paper labels and informational inserts can be unwieldy, bulky, and challenging to manage. Ever-changing regulations and new research often make the information on them out of date almost as soon as a new drug hits the market.
Outsourcing-Pharma (OSP) recently discussed the future of e-labeling with Sivakumar Thiagarajan (ST), vice president of R&D for clinical, regulatory and safety at Indegene (an Indian life-sciences firm serving pharma companies). The discussion touched upon the headaches tied with physical labels, and how electronic labels might help ease the pain.
OSP: Could you please tell us a little bit about the challenges and problems associated with paper labels and inserts?
ST: Challenges faced with physical label are due to its inflexible approach and non-scalable processes. Pharmaceutical companies encounter multiple problems to track and implement frequent label updates in order to provide accurate information to the patients and healthcare professionals; removal of labels from market becomes even more challenging in case of a product recall.
There are content inconsistencies across markets due to the region-specific regulations, along with an increased cost associated with physical labels. The physical nature of labels causes delay in dissemination of safety information to both healthcare professionals/patients.
Often due to limited size of the paper, a lot of text is cramped by using small font size resulting in impaired readability. In addition, physical labels do not provide any personalized information, hence patient has to search for the relevant text.
OSP: Why do you think the industry has relied on the paper and physical information?
ST: Paper labels are mandatory and the undisputed way to deliver information. However, with advancement in technology the pharma industry is looking at distributing the labels electronically and overcoming the existing limitations.
Internet has become widely available in recent years except in some remote areas where the connectivity can still be an issue. In the current scenario, a sub-set of the patient population is not equipped with mobile phone and/or are not tech savvy. The present regulations do not mandate use of electronic labels and is optional.
As a result, both physical and electronic labels will co-exist in the foreseeable future. Regulators and pharma companies will have to focus on both so that the updated information reaches every end-user possibly in real time.
OSP: Similarly, why do you think e-labeling solutions have not taken off more rapidly and widespread than they have?
ST: Transition from physical label to electronic format is not as fast paced as one would expect. The following are some of the reasons:
- Currently paper label/physical information is mandatory and e-labels are optional
- A sub-set of the patient population is not equipped with mobile phone and/or are not tech savvy resulting in the co-existence of both the physical and e-labels in the interim.
- Regulatory reluctance to adopt new technology as they may be unsure how the new technology would help them to monitor and track compliance across regions.
- There is a lack of proper equipment and technology support as well as lack of ownership for hosting and controlling information on the database, especially in developing countries.
- Harmonization of labeling information is not planned systematically to comply with local regulations.
- Another challenge is effective collaboration between regulators and manufacturers to design a robust process for implementation of e-labeling.
- And finally, there is an ongoing disagreement whether the labeling content will be hosted on company’s website, health authority website or if it will be accessed from a third-party website.
OSP: Could you please tell us a little bit about the history of electronic labeling—how it came about, how it has evolved, and what types of technology have been used since it arrived on the scene?
ST: Electronic labeling started way back in 1999 when FDA started receiving labeling documents in Portable Document Format (PDF) and later on adopted a new technology called extensible markup language (XML). The pivotal event was in 2003, when US FDA published regulations (the electronic labeling rule), specifying the content of labeling to be submitted electronically.
Major pharma players have started adapting Structured Product Labeling (SPL) and are developing automated system using SPL for processing and managing labels. The electronic version of the package insert (PI) and patient information leaflet (PIL), is distributed via electronic means, such as through a machine-readable QR code, barcode or URL on the product carton; the QR code is linked to a web page that can be updated to include additional information. Companies are using XML technology to share information easily with partners, suppliers, and end-users.
OSP: What are the benefits of e-labeling for the pharma company?
ST: Electronic labeling can benefit pharmaceutical companies by improving compliance tracking, and providing updated information to the end user in real time. E-labels being customizable helps pharmaceutical companies to provide personalized product information based on the needs of the patients and healthcare professionals; they also increase efficiency, reduce environmental impact, and are cost-effective.
OSP: What are the benefits of e-labeling for the patient?
ST: Patients can access personalized updated information in real-time depending on their medical conditions. The information will be made available in the language of choice and in the form of videos, e.g. demonstration of how to self-administer a particular medication.
Also, individuals with impaired vision will have an advantage of changing the font type and size of the letters displayed on the screen. This label will have a search function, which facilitates easy access to information.
The information disseminated by electronic label will be more presentable and user-friendly thus helping them to understand the treatment regimen better which in turn will improve the standard of care.
OSP: Are there benefits for any other stakeholders you’d like to mention?
ST: Healthcare professionals (HCP) will also benefit by accessing the updated personalized information depending upon the patient condition faster, e.g., if they are looking for drug to drug interaction for a particular drug, search function will help them to access relevant information, thereby reducing human errors and benefiting patient care.
OSP: What challenges and opportunities exist with e-labeling regarding regulatory requirements/compliance?
ST: The main challenge could be regulatory reluctance to adopt new technology as they may be unsure about its benefits while monitoring and tracking compliance across regions. Another challenge is the lack of harmonization across regions.
There are no clear regulations and guidelines regarding e-labeling from any of the health authority, which further makes it difficult for pharma companies to implement this process. On the other hand, e-labeling brings in an opportunity for pharmaceutical industry to efficiently track country-wise compliance and will help in establishing a centralized labeling repository which can be accessed with ease.
Adopting e-labeling will provide detailed and personalized information on a product with improved traceability of products and a positive environmental impact.
OSP: Is there a difference in the market attitudes toward and acceptance of e-labeling in different parts of the world? If so, could you please talk about these differences, and possibly explain why the gaps?
ST: Different parts of the world are at different stages of e labeling. Talking about global markets, US FDA has released guidance on electronic labeling. Approved labels are available on DaliyMed (official website). Canada is already undergoing transition to accept XML format of product label which will later on become a mandatory requirement after the successful transition.
However, on the other side of Atlantic things are slightly ahead. European Medicines Agency (EMA) issued guidelines to implement electronic product information (ePI). This is adapted for electronic handling and allows dissemination via the world wide web, e platforms, and print.
Additionally, several health authorities in emerging markets are discussing the possibilities of implementing e-labeling. Regions like Australia, Singapore, China, Malaysia, etc. have adopted structured text for labeling, according to defined standards.
The market attitude differs due to the local regulations of a particular country. Adopting electronic labeling would require amendment of countries regulations which would place additional responsibilities on regulators and drug manufacturers; also, to date no health authority has accepted e-labels as an alternative to physical labels.
OSP: Could you please talk about TransCelerate’s involvement in the global discussion around e-labeling?
ST: TransCelerate BioPharma Inc. (USA), a non-profit organization is collaborating with pharmaceutical companies globally to create solutions and address barriers that are inhibiting them to deliver efficient patient care. They are also trying to create awareness and facilitate e-labels initiative in patient centric approach; the organization is collaborating with health authorities to evolve regulatory requirements.
OSP: What sorts of industry attitudes and market conditions need to change for e-labeling to become more widely adopted?
ST: Appropriate implementation of e-labeling requires extensive collaboration and co-ordination between different agencies like regulatory, safety, device and pharmaceutical companies. Another challenge is establishment of robust process between regulators and manufacturer for regularly updating and maintaining label text. There needs to be a transition period during which involved agencies can work together to bring this process into reality.
Pharmaceutical companies also need to maintain SOPs for managing both physical and electronic labels together during the transition phase. They should coordinate with local health authorities and arrive at mutually agreed expectation for updating both simultaneously during this time. Once these processes are well established paper label could be phased out at a pilot scale in suitable markets.
OSP: Do you have anything to add about e-labeling that we didn’t touch upon in the above questions?
ST: There is a compelling need to automate labeling process in order to ensure content consistency across markets. To bring this technology into reality, a robust content management powered by Artificial Intelligence (AI) is warranted. Integrated content model needs to be developed to ensure consistency across the labels in various markets by minimizing errors.
AI along with Natural Language Processing (NLP) business rules can be coupled with local country requirements to manage drug label with minimal human intervention. In addition, personalization of labels needs strong data analytics and robust business rules, so that correct information is accessed by the individual without any difficulty. Content mapping will help to automate the flow of information from multiple data sources to the respective product labels.
One of Indegene’s technology initiatives is the intelligent content enabled labeling solution, which is an integrated end-to-end solution to manage labeling content. This platform uses AI/ML technologies such as NLP/NLU to effectively and efficiently convert labeling documents into a digital format based on semantics. These semantic units, called components, can be assembled together based on the endpoint requirements.
Users are able to define relationships among components to enable automation of content re-use and re-purpose. This automation helps to cut down the lead time significantly while ensuring better compliance and consistency. The platform is able to easily deliver labeling content in any format (xml, json, html), ensuring wider and more effective delivery of Labeling Content. This ensures that updates to labeling documents can be made faster and more accurately and that this information can be disseminated to HCPs and patients effectively and efficiently using a variety of channels (such as emails, websites, NLMs and mobile apps).
Every region will need a customized solution to make this a success. If implemented properly, this technology can start a new era in labeling which will directly improve regulatory framework and patient care.