In Canada, the next step for pharma serialization is planned for the end of 2023. In doing so, the country aims to improve tracking along the supply chain as well as patient safety. The North American country is thus pursuing the goal of providing all pharmaceuticals with a GS1 DataMatrix at the primary and secondary levels. What are the requirements for Canadian codes, how are pharmaceuticals classified, and what is the rest of the timeline?
Title: Roadmap to the Implementation of GS1 DataMatrix Barcodes on Pharmaceuticals in Canada.
Competent authority: Canadian Institute for Safe Medication Practices (ISMP), Canadian Patient Safety Institute (CPSI).
Products: All pharmaceutical products
Code type: GS1-2D DataMatrix with Global Trade Item Number (GTIN)
Aggregation: No aggregation is necessary
What are the goals?
According to the GS1 document on the introduction of DataMatrix barcodes in Canada, medical errors are the third leading cause of death in North America. In addition, the COVID-19 pandemic has highlighted the vulnerabilities within global healthcare systems and supply chains. One way to address these problems is by implementing a thorough system for tracking medication. It should enable the following:
- Reduce medical errors and improve patient care.
- Traceability for each product, up to bedside scanning and patient records
- Batch-related product recalls
- Avoidance of risk and the waste of resources that would be dedicated to relabeling barcodes at the primary and secondary packaging levels
- Forecasting data to avoid shortages
- Predictive analytics for clinical outcomes and value-based procurement
- Insight into the supply chain for inventory management
- Preventing fraudulent or low-quality products from entering the Canadian supply chain
Classification of pharmaceuticals
Pharma Serialization in Canada is required for all pharmaceuticals, whereas in many other countries, it is focused only on prescription drugs. Canada divides drugs into four different “Schedules”.
- Schedule I: This includes prescription drugs that are dispensed by pharmacists to patients after a physician’s diagnosis. They may only be purchased in a controlled environment defined by each province. This usually refers to pharmacies.
- Schedule II: These drugs do not require a prescription but must be dispensed by pharmacists. Therefore, they cannot be freely available in the store but must be kept out of the reach of the public.
- Schedule III: They are also available without a prescription, but do not need to be stored out of reach of customers. Further, they are located on shelves within pharmacies, which ultimately places their sale under the supervision of pharmacists.
- Unscheduled: These medications can be sold without supervision and are available in regular stores. They only include instructions for use.
The implementation of Pharma Serialization in Canada happens in several steps. Accordingly, the timeline is divided into three parts and provides individual compliance dates for manufacturers, distributors, and pharmacies.
- Manufacturer: December 31, 2021
- Distributors: December 31, 2023
- Pharmacies: December 31, 2025
The requirements of these stakeholders also differ. Manufacturers are responsible for affixing the GS1 DataMatrix to the primary and secondary packaging levels and assigning a permanent GTIN. They must assign and, if possible, mark a GTIN to the unit-of-use level, in addition to a GS1-128 code at the carton level with optional GS1 DataMatrix. The manufacturers’ deadline is extendable by up to two years, to December 31, 2023. In return, distributors must be able to properly scan these codes, store the goods, and store the data in an enterprise resource planning (ERP) system. The main component of this is the availability of the necessary equipment. Pharmacies have a similar task. They must also be able to scan the various codes and store the medications. In addition to the ERP, they need to insert the data into electronic medical records and product portfolio management systems.
The development of Canadian pharma serialization is in close interaction with GS1. Accordingly, code requirements are similar to other serialization regulations. A GS1 DataMatrix is mandatory at the individual or bundle level, which includes a Global Trade Item Number (GTIN), expiration date, and lot number. GS1 additionally recommends a serial number. At the carton and case level, a GS1-128 barcode is mandatory. It has to include a GTIN, expiration date, lot number and an optional serial number. In addition, a voluntary GS1 DataMatrix with the same data is recommended. Since only the 2D DataMatrix will find use in the future, the stakeholders are thus being prepared. However, there are no plans for Aggregation.
You can also take a look at our other articles dedicated to national regulations: