Marcelo Cruz, Head of Marketing and Business Development at Tjoapack, discusses whether digitisation can fundamentally change the way the pharmaceutical supply chain operates.
Over the last decade, the pharmaceutical supply chain has often been criticised for a lack of transparency and compromised security, both of which can have an impact on overall patient safety should counterfeit products enter the supply chain. As a result, in recent years we have seen the implementation of new regulations such as the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) in order to address these issues.
Now that the initial implementation period of such regulations has passed, companies in the supply chain are starting to investigate additional digitised solutions and the efficiencies that can be generated by an enhanced insight into operations and movement of products through the supply chain.
“A supply chain using blockchain for data transfer and management can benefit significantly from increased compliance with serialisation regulations”
Supply chain improvements
Improved visibility is one advantage of a digitised supply chain. Where firms may previously have used paper-based processes to record data, the use of a digital process can allow for more accurate and up-to-date data transfer between parties, securely. This enables companies to leverage the data and identify the points at which processes can be improved, such as identifying regular delays at a certain point in the chain and actioning ways to resolve them.
Replacing legacy technologies with new digital solutions can also enable companies to use and share real-time inventory data, which helps to automate the movement of products through the chain from manufacturers to patients. Where members of the supply chain have access to correct, easy to understand and dependable data, businesses will be able to refine internal operations and make more informed decisions.
Through better data management and sharing, order forecasting can also be improved, and we will see the supply chain become more agile in responding to product requirements. This can permit firms to react more efficiently to market demand and ensure a product reaches the patient swiftly and safely.
Serialisation and internal process efficiencies
Serialisation was one of the main catalysts for businesses to consider a more digital approach to data management and exchange. The FMD, for example, requires all products to be fitted with a barcode containing a product code, batch number and expiry date, as well as a unique serial number or unique identifier (UI). These features all help to ensure that medicines are verifiable at the point of dispense.
With such a vast amount of data to store and transfer, many companies have moved to implement new data management solutions, which has in turn presented additional opportunities to identify potential process inefficiencies within their internal operations.
To take full advantage of digital supply chain processes, companies often need to focus on their internal procedures as a starting point. It’s important that firms ensure that the data they capture is readable and usable by computerised systems and analytics tools. These improvements in data management will allow firms to better forecast product demand. Better visibility of the value stream can also enable organisations to make more informed decisions, paving the way for the implementation of automated processes as well as targeted and measurable process improvement projects.
Firms are now exploring the use of digitised solutions that can provide analytics to improve inventory management, enabling them to react more intelligently to market demand and improve internal operational efficiency. These platforms often allow for improved auditability.
Many of these solutions use blockchain. Blockchain creates an immutable ledger of data that can act as a digital mirror of the supply chain. New data entries are verifiable by the other partners in the chain, which allows firms to provide dependable, authenticated and up-to-date information to other partners in the chain. A supply chain using blockchain for data transfer and management can benefit significantly from increased compliance with serialisation regulations, allowing products to be trackable through the full supply chain from manufacture to dispense.
Barriers to implementation
Implementing a digital solution can be a daunting task for many firms, especially when considering how to relocate existing records from legacy systems into new platforms. Many companies have looked to third parties to assist with the integration of new systems to minimise the risk of problems or data loss that could be associated with installation by inexperienced parties.
The move towards digitisation has been significant in 2019, particularly by companies in the EU after the FMD was brought into force. More and more firms are starting to investigate potential efficiencies offered by the use of new digital platforms and are looking for ways to implement these solutions into the current supply chain.
Top 5 Takeaways
- Use of a digital process allows for more accurate and up-to-date secure data transfer.
- Order forecasting can be improved through better data management and sharing.
- Blockchain creates a ledger of data that acts as a digital mirror of the supply chain.
- Third parties are able to assist with the integration of new systems.
- New digital platforms offer greater potential efficiencies.
Marcelo Cruz is Head of Marketing and Business Development at Tjoapack. Go to www.tjoapack.com