GS1 DataMatrix Barcodes on Pharmaceuticals in Canada

As the world celebrates the 50th anniversary of the barcode, Canada is advancing action to align with the global movement for the adoption of GS1 DataMatrix (2D barcodes) on pharmaceuticals at all packaging levels. All categories of pharmaceuticals are included — prescription drugs, over-the-counter (OTC), behind-the-counter, and natural health products (NHP)*.

Patient safety, best practices in dispensing to patient record workflow, improvements to supply chain traceability capabilities, along with the elimination of pharmaceutical barcode relabelling are the strategic imperatives driving this movement.

The Roadmap to the Implementation of GS1 DataMatrix Barcodes on Pharmaceuticals in Canada guides the community-led 2025 deadline for system-wide capabilities in Canada to scan, store and process the GS1 DataMatrix barcode that contain the Global Trade Item Number (GTIN - the number below the barcode), lot number, and expiry date (serial number is optional).

Readiness expectations apply to all relative stakeholders and their solution providers:
Manufacturers - December 31, 2021 to December 31, 2023
Distributors - December 31, 2023
Pharmacies - December 31, 2025

*It is recognized that the transition to a single GS1 DataMatrix barcode for Behind-the-Counter (BTC), Over-the-Counter (OTCs), and Natural Health Products (NHPs) will align with the global movement for consumer goods, and in alignment with the Global 2D Migration program.

Additionally, medical devices sold at the retail level will also align with the Global 2D Migration program movement for consumer goods.

Discussions about the global movement towards 2D barcodes for consumer goods and foods are underway, and readiness timelines are expected to extend beyond 2025. Canadian timelines will be established through GS1 Canada’s community management process. Should manufacturers of BTCs, OTCs, NHPs, and medical devices wish to voluntarily adopt GS1 DataMatrix in advance of the pending global timelines, then manufacturers are encouraged to prioritize those products with the potential to be dispensed due to a prescription (for example, some shampoos, OTCs and diabetes test strips can be prescribed and dispensed or administered while in hospital or Long-Term Care).

Additionally, manufacturers are encouraged to follow the GS1 DataMatrix Roadmap for product samples. Samples which have the potential to be recalled or to be dispensed in a clinic or hospital setting require traceability, therefore, benefit from effective barcoding.

To support the transition period for distributors and pharmacies, two barcodes are recommended to be included at the saleable (linear and GS1 DataMatrix), except for products whereby a barcode does not exist today or where there is small usable space, a GS1 DataMatrix should be used.

Concerns for safety have given rise to the urgent and strategic request for greater supply chain visibility capabilities enabled through global standards, including barcodes. With the reality that medical errors are the third leading cause of death in North Americai, combined with the COVID-19 crisis exposing the vulnerabilities linked to significant lack of visibility in the supply chain and resulting challenges with drug shortages, the pharmacy community is advancing a pharmaceutical barcoding implementation action plan and a corresponding government relations strategy.

Global leaders of pharmaceutical manufacturing, including the United States, European Union, and India, all have regulations, with specific deadlines to deliver critical data such as the Global Trade Item Number, lot number and expiry date within one globally-standardized barcode. Considering more than half of Canadian pharmaceutical production is exported and over 78% of the Canadian pharmaceutical market is supplied by imports from the US and EUii, Canada is in a strong position to leverage manufacturer readiness in a significant way.

Canada’s goal is that only one GS1 DataMatrix barcode will be on pharmaceutical products at both the primary and secondary packaging level. This level of barcode readiness will enable:

  • Reduction in medical errors and improvements in patient care outcomes
  • Traceability capabilities for each product right down to bedside scanning and to the patient record
  • Lot-based product recalls to the inventory and patient-level
  • Elimination of risk and resources dedicated to barcode re-labelling at the primary and secondary packaging level
  • Forecasting data to mitigate shortages
  • Predictive analytics for clinical outcomes and value-based procurement
  • Visibility into the supply chain for inventory management
  • Reduction of waste and costs
  • Prevention of fraudulent or poor-quality product entering Canada’s supply chain

It is important to note that the roadmap was established subsequent to various requests including individual GPO, retailer, distributor and healthcare provider requests, in addition to recommendations from ISMP/CPSI Joint Technical Statement for medication barcoding, and the Public Health Agency of Canada’s recommendations for vaccines. Endorsement for this action has been reinforced for many years by Canada’s leading healthcare associations.

i Makary MA, Daniel M. Medical error - the third leading cause of death in the US. BMJ. 2016;353:i2139

ii Statistics Canada, Industry Canada trade - online data

Implementation Requirements and Timelines

Manufacturers

Distributors

Pharmacies

Shall:

  • Affix a GS1 DataMatrix barcode to primary and secondary packaging
  • Permanently assign a unique GTIN to each packaging level
  • Assign, and where feasible mark a GTIN to the Unit of Use level
  • Affix a GS1-128 at the case level and accept the addition of an optional GS1 DataMatrix, Both barcode symbologies must contain the same GTIN
  • Barcodes include static and variable data as noted below:
Static Data:
  • GTIN
Variable Data:
  • Lot Number
  • Expiration Date
  • Serial Number (optional)*

Implementation Timeline: Dec 31, 2021 to Dec 31, 2023**

What do Manufacturers need to do to determine if they are prepared?

  • Assess printing software - conformance to ISO / IEC 16022 standard and GS1 General Specifications.
  • Assess if packaging material is suitable to carry a barcode
  • Verify if GTINs are:
    • Allocated according to the GS1 Healthcare GTIN Allocation Rules
    • Properly formatted so GS1 DataMatrix is created using the GTIN-12 or GTIN-13 in 14-digit format (using leading zero(s))

* Including serialized data is optional, however it is recommended that manufacturers who include serialized data in barcodes to meet regulatory requirements for other countries, should include serialized data in the barcodes destined for Canada.

** For manufacturers who currently do not have production lines with variable data such as lot and expiry, the implementation deadline recommendation is a phased approach between 2021 to 2023. It is recognized that the transition to a single GS1 DataMatrix barcode for over-the-counter and natural health products will align with the global movement for consumer goods, and in alignment with the Global 2D Migration program. These timelines are yet to be announced, and expected to extend beyond 2025. To support the transition period for distributors and pharmacies, two barcodes are recommended to be included at the handling level (linear and GS1 DataMatrix), except for products whereby a barcode does not exist today or where there is small usable space, a GS1 DataMatrix should be used.

Shall be able to scan, store and process into legacy ERP, ordering and distribution systems:

  • A GS1 DataMatrix for the primary and secondary packaging
  • Unique GTINs at each packaging level
  • GTINs at the Unit of Use level
  • GS1-128 at the case level
  • Barcodes include static and variable data as noted below:
Static Data:
  • GTIN
Variable Data:
  • Lot Number
  • Expiration Date
  • Serial Number (optional)*

Implementation Timeline: December 31, 2023

What do distributors need to do to determine if they are prepared?

  • Assess scanning equipment - confirming camera-ready barcode scanning equipment is in place to read both linear and 2D barcodes.
  • Verify if databases and systems are:
    • Properly configured so the 14-digit GTIN can be stored in a 14-character data field
    • Can ingest/store lot number and expiry date (to enable lot-based recalls and stock rotation)
  • Plan for future: establish a plan to scan and store serialized data in your internal systems

Shall be able to scan, store and process into legacy ERP, PPMs, EMRs:

  • A GS1 DataMatrix for the primary and secondary packaging
  • Unique GTINs at each packaging level
  • GTINs at the Unit of Use level
  • GS1-128 at the case level
  • Barcodes include static and variable data as noted below:
Static Data:
  • GTIN
Variable Data:
  • Lot Number
  • Expiration Date
  • Serial Number (optional)*

Implementation Timeline: December 31, 2025

What do pharmacies need to do to determine if they are prepared?

  • Assess scanning equipment - confirming camera-ready barcode scanning equipment is in place to read both linear and 2D barcodes.
  • Verify if databases and systems are:
    • Properly configured so the 14-digit GTIN can be stored in a 14-character data field
    • Are capable of ingesting/storing lot number and expiry date (key to lot-based recalls and stock rotation)
  • Plan for the future: establish a plan to scan and store serialized data in your internal systems.

The recommended Adoption Roadmap for Pharmaceutical Barcoding in Canada was approved with the following conditions understood:

  • The recommended Adoption Roadmap for Pharmaceutical Barcoding in Canada was approved understanding that the Roadmap and related readiness timelines will continue to be assessed through sector and barcoding scorecarding audits. Any recommended adjustments will be brought forward to the GS1 Canada Pharmacy Working Group and Healthcare Pharmacy Board.
  • The roadmap and related readiness timelines will continue to be assessed through sector and barcoding scorecarding and audits. Any recommended adjustments will be brought forward to the GS1 Canada Pharmacy Working Group and Healthcare Pharmacy Board
Barcoding at all packaging levels: Barcoding at all packaging levels is different, right from the unit of use to each primary packaging level, it continues right through the secondary box, and continues with case and pallet levels. Similarly, it goes from unit of use to blister cells, continuing to each of the multiple blister cards and right through case or shipper, and pallet level. Primary and Secondary Packaging: Each primary packaging has a GTIN before getting into the secondary box packaging.

Related Resource Videos

Need Help to Ensure Your Barcodes Scan?

  • Barcode scan verification – to verify barcodes you have created, a report will be generated and shared with you. The report lists all the issues with the barcode or confirms that there are issues.
    For additional information contact info@gs1ca.org

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