The primary purpose of labeling in life sciences is to ensure there is effective identification of the product, its origins, any appropriate instructions and precautions, and understanding of their proper usage. While there is a significant effort in life science companies to ensure compliance to local requirements, there continues to be a challenge in the consistency in outputs, traceability of decisions, and effectiveness of the language for healthcare professionals and patients alike.
The industry has started to take action to automate the cumbersome and highly manual process while it continues to strive toward digitized and electronically accessible labeling information. A number of changes have started to take place due to policy updates, industry initiatives, and advocacy demands demonstrating that improvements are starting to take shape.
Vladimir Penkrat who heads Regulatory Affairs at Indegene along with Dr Sonica Batra who heads Regulatory Operations at Indegene recently sat down with an audience of industry leaders to discuss experiences and best practices to drive toward a future ready labeling operation.
Challenges related to labeling are not new in the industry. More than 50% of medication errors occur due to drug labeling. Between January 2017 and September 2021, most recalls were of pharmaceutical drugs, accounting for 85.2% of all recalls. Each year, 134 million adverse events occur in hospitals due to medication errors that resulted in 2.6 million deaths.
To improve accuracy and timeliness of label information there are legislations that are triggers for change for example, there is ongoing work to improve communication with patients through electronic product information (ePI). ePI is the EU common standard developed with the goal of expanding public access to accurate and up-to-date information on medicines, labeling, and package leaflets. This includes a pilot program in Belgium and Luxembourg that is being run in collaboration with the pharmaceutical industry and regulatory authorities. This program aims to create new electronic labeling for human prescription drugs, known as Electronic media in prescription drug labeling. ePI is also anticipated to improve patient safety and health systems’ resilience. This is because electronic labels can be easily updated with the latest information, and healthcare professionals and patients can easily access them. They can also be used to create unique identification codes, which can help combat counterfeit products.
To digitize and standardize label information similar to the European Medicines Agency (EMA) initiative in ePI, some health authorities are accepting label information by applying Structured Product Labelling which is a document Extensible Markup Language (XML) standard approved by Health Level Seven (HL7) and adopted by the FDA to allow for more standardized exchange of product and facility information. The benefit of these data centric constructs allow for a standard to be formulated so that data exchange can be more effective.
As Health Authorities around the world are constantly updating their guidelines and regulations, it is becoming imperative for companies to keep up. Additionally, the industry is under increasing pressure to improve efficiency and reduce costs, while also maintaining the highest standards of quality. The future of labeling in the life sciences industry is likely to be shaped by several factors, including advances in technology, changes in regulations, and the evolving needs of customers. Some of the key demands that are likely to emerge include:
The need of the hour demands a global labeling organization that makes use of technology to improve the ability to track and manage label updates both centrally and for each market, while the industry turns the focus toward effective label language and improved access to good label information for patients and HCPs. Digital labeling is demonstrating strides. For example, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website allows for barcode access to the contents of the package insert with a smartphone and will eliminate paper versions of package inserts by April of 2023.
While the industry continues to improve label operations, there is an increasing focus on patient needs to ensure that labeling information and communication is future ready. This means taking steps to ensure readability of patient information as well as reducing the number of labeling templates.
In order for an organization to take initiative in this area, improvements in organizational resources are to be made with clearly defined responsibilities and communication pathways. Once you have clarified this, the creation of effective processes and optimal use of technology come together to enable a future ready labeling business.
A five steps framework for process redesign can be applied. It can identify the key areas where improvements can be made in labeling processes. This includes identifying failure points around people, process, and technology, and then mapping the labeling process to identify opportunities for automation.
*Find more details for each step in the presentation embedded in this blog post.
Once these opportunities have been identified, companies can prioritize their target needs and refine their objectives to execute a plan. This includes evaluating relevant opportunities across the industry and executing a labeling technology roadmap for change.
Ultimately, the goal of implementing change initiatives in the labeling business allows for an effective roadmap toward digital approaches to reduce medication errors and improve the patient experience.
Digital labeling solutions are designed to improve the efficiency and effectiveness of the labeling process. One can avoid challenges by focusing on the following objectives:
In conclusion, digital labeling is becoming increasingly important in the life sciences industry, allowing companies to comply with changing regulations and improve efficiency. Companies need to be aware of the challenges, future demands, and industry initiatives driving this change and take action accordingly. This includes process mapping, investigation, technology assessment, implementation, and objectives to outcomes. With the help of digital labeling, companies can ensure compliance, reduce costs, and improve quality control, ultimately helping them to stay competitive in the industry.
As you explore the benefits and challenges of digital labeling in the life sciences industry, we encourage you to connect with our subject matter experts. They can help you with your specific challenges and develop a plan to move successfully ahead with digital labeling. Do not hesitate to reach out and schedule a consultation today.