How the pharmaceutical industry is implementing serialization

New legislation requiring pharmaceutical companies to implement 'serialization' is coming into force. This means that no counterfeit product should enter the supply chain and no legitimate product is diverted from its intended destination.

Pharmaceutical product serialization is being introduced throughout the world, and there is consensus between regulatory agencies about the importance of the control and tracking of pharmaceutical products. Some drug regulators, like the U.S. Food and Drug Administration (FDA) are relatively advanced with serialization requirements whereas other parts of the world are at earlier stages.

Where legislation is in force, a failure to meet serialization requirements means that drug products cannot be sold into the particular marketplace. For the U.S., from November 27, 2019 pharmaceutical wholesalers must buy and sell only serialized drugs. In addition, repackagers must also serialize drugs. By November 27, 2020 all dispensers of medicines must buy and sell only serialized drugs. Finally, by November 27, 2023 a full enhanced drug distribution security comes into effect. For this, unit-level traceability mandated (this means every individual container of a pharmaceutical or healthcare product).

The core purpose of serialisation is to prevent fraud (through reducing opportunities for counterfeit medicines to enter the supply chain) and to enhance patient safety. For pharmaceutical manufacturers to meet the requirements of serialization, this involves careful planning and considerable cost. To achieve serialization, every drug product pack needs to be uniquely identified with digital information - a machine-readable code, and for the product to be registered in an external database to permit each individua item to be traceable. Under U.S. law (the U.S. Drug Supply Chain Security Act, 2017), the machine-readable form must be a 2D Datamatrix barcode (a barcode consisting of black and white "cells" or modules arranged in either a square or rectangular pattern) that contains the following:

National Drug Code, Serial number, Batch number, Expiration date.

The idea is that this information can be accurately decoded using common scanning equipment before the medicine is dispensed to the patient. This means that the nurse or clinician can have a high level of certainty that the medicine is the one produced by the manufacturer and that a fake medicine has not been switched or that the medicine has not been tampered with. Two technologies are helping pharmaceutical companies with the serialization requirements: tag technology and blockchain.

Tag and trace technology

Track-and-trace products can be deployed from the point of packaging to the pharmacy. These technologies help to determine the current and past locations (and other information) of a unique item. While this technology does not provide the complete solution, it helps to minimize attempts to interfere with the supply chain. Radio-frequency identification (RFID) and barcodes are two common technology methods used to deliver traceability.

Blockchain

Once the product enters the supply chain, the database needs to be updated with different stages of movement and any changes to ownership. The difficulty in achieving this is with limitations to current technology. The more advanced technology is found with packaging lines, and where technology is less advanced is with shipping. This is beginning to change as pharmaceuticals start to embrace blockchain. Although blockchain is not yet permitted be used in the pharmaceutical industry to label actual drug products, the digital ledger technology is being implemented as a two-dimensional barcoding system. The technology is then used to authenticate containers throughout the supply chain.

Many pharmaceutical manufacturers hope that gradually blockchain will be accepted as the primary tool to enable full serialization. Which ever technologies are being adopted now or in the near future, serialization will generate massive amounts of data for global companies that will need to be retained for many years to meet compliance requirements. This places additional strain on information management systems and will itself drive further investment into digital technologies.