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The Future of Labels: Embracing Digital Technology for Enhanced Efficiency

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Mike Baird
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Embracing Digital Transformation: The Future of Pharmaceutical Labeling

Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.

Now, well over a century later, a new vision for labeling is taking shape – and in some jurisdictions, it is already a reality. Through technologies like Near Field Communication (NFC) tags and GS1 barcodes in or on packaging, pharmaceutical companies have powerful tools to enhance product traceability, safety, and patient engagement. They also foster better and more-informed communication among stakeholders.

The age of e-labeling

In the European Union (EU) regulatory context, e-labeling is often referred to as electronic product information (ePI). Typically, where e-labeling has been introduced, stakeholders can access product information online via a 2D barcode scanned with a mobile device and app. This brings the person to relevant digital product information, such as a package leaflet, the Summary of Product Characteristics (SmPC), or other product-related information.

5 Advantages of e-Labeling

1. Leverages existing digital documentation

Electronic submissions to regulatory agencies today are the norm, and most documents begin life in a digital format. These approved electronic documents can be easily leveraged for e-labeling and healthcare apps.

2. Real-time updates

Updating information to include new information about a product (e.g. side effects) takes place in real time for immediate distribution. In the case of Japan, which, after a two-year transition period, implemented e-labeling in 2023, e-labeling is stored in an official online repository on the Pharmaceuticals and Medical Devices Agency (PMDA) website. Furthermore, e-labeling can be distributed immediately after marketing approval, reducing production and distribution cycles.

3. Enhances compliance

• E-labeling is easier to distribute across different regulatory jurisdictions than physical labeling.
• E-labeling can be better stored and tracked in workflows. It also meets the need among regulatory bodies for highly searchable formats, allowing better oversight.
• E-labeling can be bundled with other records (electronic healthcare records, patient records, etc.).

4. Cost-effective and environmentally friendly

• Saves paper
• Reduces carbon footprint due to reduced physical manufacturing and distribution
• Avoids cautionary overproduction of labeling
• Overcomes space limitations that prevent instructions on environmentally friendly disposal of medications and packaging

5. Personalization and customization

Technologies today mean that electronic product information can be shared efficiently across diverse systems, devices and – through personalization and customization – stakeholder groups in different regulatory jurisdictions.

  • Readability: E-labeling allows for easy language versions or simpler layouts without the space limits of physical packaging.
  • Accessibility: E-labeling and other enabling technologies allow expanded access to information. For example, information can be presented in multilingual versions in regions, even for smaller language groups (e.g. Inuktut languages in Canada). Along with limited Braille on packaging, text-to-audio capabilities can be used to read out product information aloud online. Patients can magnify text for better reading in internet browsers.
  • Personalized patient support: More-detailed information can be provided, tailored to specific disease and patient groups, and to different medical specialists. Technologies are readily available that allow efficient delivery of customized information, including wearable devices, smartphones and apps, as well as online platforms with personalized records. We now have the capability to bundle information optimally for stakeholders within apps, including electronic health records (EHRs), electronic medical records (EMRs), personal records, and more.

Enabling technologies for labeling

The sharing of information is being simplified by the phasing-in of the Fast Healthcare Interoperability Resources (FHIR) format. This is based on structured content and application programming interfaces (APIs), which allow systems to “talk” with each other. FHIR is revolutionizing data sharing at all levels: patient, practitioner, caregiver, regulatory, healthcare organization and insurer, and beyond. It creates a basis for smart devices to deliver, bundle and share information. (See here for FHIR: Transforming Product Labeling.)

GS1 barcodes, RFID and NFC

The term barcode today goes beyond earlier linear 1D scan codes with bars and spaces to also include 2D QR codes and 2D Data Matrix codes (the difference is in appearance and the amount of data they can store). Barcodes are playing a crucial role in preventing drug counterfeiting by making products traceable through unique identifiers. This generally includes product code, serial number, batch or lot number, and expiry date. In the EU and US, it is a 2D Data Matrix code. The gold standard is the GS1 standard, administered by the not-for-profit organization of the same name.

Like 2D barcodes, NFC tags offer the advantage of being easily scanned by consumer mobile devices. Embedded in packaging, these tags can be read effortlessly at very close-range using smartphones, taking the consumer to the information they require. Additionally, pharmaceutical companies utilize Radio Frequency Identification (RFID) tags in their supply chains to enable real-time inventory tracking, product authentication, and enhanced supply chain visibility.

These technologies collectively help pharmaceutical companies comply with regulatory requirements for supply chain safety and product authenticity, such as the Drug Supply Chain Security Act (DSCSA) in the U.S. and the Falsified Medicines Directive (FMD) in the EU.

Labeling Challenges

Pharmaceutical labeling is undergoing enormous change – regulatory, technologically, and in its patient-centricity. This presents challenges in terms of compliance and accuracy. First and foremost, e-labeling requirements still differ throughout the world, despite an overall trend toward harmonization of regulations for product labeling. More detail, greater customization, and regulatory change itself are making labeling compliance more complex and difficult.

• Workloads are increasing due to more information
• Physical and e-labeling formats (and other information) must be consistent and compliant.
• As well as verifying text and graphical elements, companies must verify and grade the readability of barcodes. In an e-labeling environment, a non-readable barcode would lead to a product recall.
• Workflows need to be adapted to the digital environment, and training is required (e.g. for transitioning to FHIR).

How TVT can help you meet these challenges

Barcode Verification:

Reliable barcode grading tools are indispensable for ensuring readability. Factors such as insufficient contrast, crowding (insufficient quiet zones around the barcode) and magnification may lead to reading issues. Your barcodes must also comply with the GS1 specifications.

TVT Barcode module detects and grades barcodes on a pass/fail result. This is based on ISO 15415, 15416 and the GS1 General Specifications, and it will grade both 1D and 2D barcodes, automatically detecting these in your digital document prior to printing. The advantage is that it allows you to resolve any issues prior to printing, saving time and streamlining approvals and turnarounds.

Electrionic labeling:

TVT has been designed for regulated industries, and to meet the new challenges of compliance in an e-labeling environment For example, TVT 12 supports FHIR and XML documents, as well as HTML for your online content, including embedded website images. After you have uploaded an approved original document in any format (e.g. Word or PDF) and a copy (e.g. PDF labeling artwork document), TVT will quickly compare the two documents for deviations. Online product information can also reviewed by TVT. Simply copy/paste the URL of the HTML version into TVT and compare the content on this page to the original approved copy. Any deviations from the approved document will be immediately highlighted. You can annotate the document for changes; an audit trail records all steps and actions. TVT can also be integrated into any digital workflow system – preparing you in the best possible way to manage your e-labeling and dual (physical and online) labeling needs.

Mike Baird, Director of Product Management, discusses how TVT has been designed for regulated industries, and to meet the new challenges of compliance in an e-labeling environment.

Find out more about how you can inspect and verify your barcode with TVT, or download and read our Barcode Compliance Guide.

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

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Mike Baird

Director of Product Management, Schlafender Hase

Mike is the Director of Product Management for Schlafender Hase.

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Embracing Digital Transformation: The Future of Pharmaceutical Labeling

Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.

Now, well over a century later, a new vision for labeling is taking shape – and in some jurisdictions, it is already a reality. Through technologies like Near Field Communication (NFC) tags and GS1 barcodes in or on packaging, pharmaceutical companies have powerful tools to enhance product traceability, safety, and patient engagement. They also foster better and more-informed communication among stakeholders.

The age of e-labeling

In the European Union (EU) regulatory context, e-labeling is often referred to as electronic product information (ePI). Typically, where e-labeling has been introduced, stakeholders can access product information online via a 2D barcode scanned with a mobile device and app. This brings the person to relevant digital product information, such as a package leaflet, the Summary of Product Characteristics (SmPC), or other product-related information.

5 Advantages of e-Labeling

1. Leverages existing digital documentation

Electronic submissions to regulatory agencies today are the norm, and most documents begin life in a digital format. These approved electronic documents can be easily leveraged for e-labeling and healthcare apps.

2. Real-time updates

Updating information to include new information about a product (e.g. side effects) takes place in real time for immediate distribution. In the case of Japan, which, after a two-year transition period, implemented e-labeling in 2023, e-labeling is stored in an official online repository on the Pharmaceuticals and Medical Devices Agency (PMDA) website. Furthermore, e-labeling can be distributed immediately after marketing approval, reducing production and distribution cycles.

3. Enhances compliance

• E-labeling is easier to distribute across different regulatory jurisdictions than physical labeling.
• E-labeling can be better stored and tracked in workflows. It also meets the need among regulatory bodies for highly searchable formats, allowing better oversight.
• E-labeling can be bundled with other records (electronic healthcare records, patient records, etc.).

4. Cost-effective and environmentally friendly

• Saves paper
• Reduces carbon footprint due to reduced physical manufacturing and distribution
• Avoids cautionary overproduction of labeling
• Overcomes space limitations that prevent instructions on environmentally friendly disposal of medications and packaging

5. Personalization and customization

Technologies today mean that electronic product information can be shared efficiently across diverse systems, devices and – through personalization and customization – stakeholder groups in different regulatory jurisdictions.

  • Readability: E-labeling allows for easy language versions or simpler layouts without the space limits of physical packaging.
  • Accessibility: E-labeling and other enabling technologies allow expanded access to information. For example, information can be presented in multilingual versions in regions, even for smaller language groups (e.g. Inuktut languages in Canada). Along with limited Braille on packaging, text-to-audio capabilities can be used to read out product information aloud online. Patients can magnify text for better reading in internet browsers.
  • Personalized patient support: More-detailed information can be provided, tailored to specific disease and patient groups, and to different medical specialists. Technologies are readily available that allow efficient delivery of customized information, including wearable devices, smartphones and apps, as well as online platforms with personalized records. We now have the capability to bundle information optimally for stakeholders within apps, including electronic health records (EHRs), electronic medical records (EMRs), personal records, and more.

Enabling technologies for labeling

The sharing of information is being simplified by the phasing-in of the Fast Healthcare Interoperability Resources (FHIR) format. This is based on structured content and application programming interfaces (APIs), which allow systems to “talk” with each other. FHIR is revolutionizing data sharing at all levels: patient, practitioner, caregiver, regulatory, healthcare organization and insurer, and beyond. It creates a basis for smart devices to deliver, bundle and share information. (See here for FHIR: Transforming Product Labeling.)

GS1 barcodes, RFID and NFC

The term barcode today goes beyond earlier linear 1D scan codes with bars and spaces to also include 2D QR codes and 2D Data Matrix codes (the difference is in appearance and the amount of data they can store). Barcodes are playing a crucial role in preventing drug counterfeiting by making products traceable through unique identifiers. This generally includes product code, serial number, batch or lot number, and expiry date. In the EU and US, it is a 2D Data Matrix code. The gold standard is the GS1 standard, administered by the not-for-profit organization of the same name.

Like 2D barcodes, NFC tags offer the advantage of being easily scanned by consumer mobile devices. Embedded in packaging, these tags can be read effortlessly at very close-range using smartphones, taking the consumer to the information they require. Additionally, pharmaceutical companies utilize Radio Frequency Identification (RFID) tags in their supply chains to enable real-time inventory tracking, product authentication, and enhanced supply chain visibility.

These technologies collectively help pharmaceutical companies comply with regulatory requirements for supply chain safety and product authenticity, such as the Drug Supply Chain Security Act (DSCSA) in the U.S. and the Falsified Medicines Directive (FMD) in the EU.

Labeling Challenges

Pharmaceutical labeling is undergoing enormous change – regulatory, technologically, and in its patient-centricity. This presents challenges in terms of compliance and accuracy. First and foremost, e-labeling requirements still differ throughout the world, despite an overall trend toward harmonization of regulations for product labeling. More detail, greater customization, and regulatory change itself are making labeling compliance more complex and difficult.

• Workloads are increasing due to more information
• Physical and e-labeling formats (and other information) must be consistent and compliant.
• As well as verifying text and graphical elements, companies must verify and grade the readability of barcodes. In an e-labeling environment, a non-readable barcode would lead to a product recall.
• Workflows need to be adapted to the digital environment, and training is required (e.g. for transitioning to FHIR).

How TVT can help you meet these challenges

Barcode Verification:

Reliable barcode grading tools are indispensable for ensuring readability. Factors such as insufficient contrast, crowding (insufficient quiet zones around the barcode) and magnification may lead to reading issues. Your barcodes must also comply with the GS1 specifications.

TVT Barcode module detects and grades barcodes on a pass/fail result. This is based on ISO 15415, 15416 and the GS1 General Specifications, and it will grade both 1D and 2D barcodes, automatically detecting these in your digital document prior to printing. The advantage is that it allows you to resolve any issues prior to printing, saving time and streamlining approvals and turnarounds.

Electrionic labeling:

TVT has been designed for regulated industries, and to meet the new challenges of compliance in an e-labeling environment For example, TVT 12 supports FHIR and XML documents, as well as HTML for your online content, including embedded website images. After you have uploaded an approved original document in any format (e.g. Word or PDF) and a copy (e.g. PDF labeling artwork document), TVT will quickly compare the two documents for deviations. Online product information can also reviewed by TVT. Simply copy/paste the URL of the HTML version into TVT and compare the content on this page to the original approved copy. Any deviations from the approved document will be immediately highlighted. You can annotate the document for changes; an audit trail records all steps and actions. TVT can also be integrated into any digital workflow system – preparing you in the best possible way to manage your e-labeling and dual (physical and online) labeling needs.

Mike Baird, Director of Product Management, discusses how TVT has been designed for regulated industries, and to meet the new challenges of compliance in an e-labeling environment.

Find out more about how you can inspect and verify your barcode with TVT, or download and read our Barcode Compliance Guide.

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

Subscribe to our blog

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