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, and 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 toward 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 that have the potential to be recalled or to be dispensed in a clinic or hospital setting require traceability and therefore benefit from effective barcoding.
To support the transition period for distributors and pharmacies, two barcodes are recommended to be included (linear and GS1 DataMatrix) at the saleable unit level. The exception is for products without an existing barcode or where there is small usable space, in which case 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 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