The pharmaceutical supply chain is a complex ecosystem with multiple stakeholders and fragmented systems. In addition, it is easy to imitate drug packaging (as they are mere artworks) and introduce spurious drug/counterfeits in the supply chain. There have been instances of high degrees of drug counterfeit, with one of the leading pharma reporting up to 0.5% of annual production as counterfeits for its blockbuster drug in the market. In the US, Drug Supply Chain Security Act was made into a law in 2013 to address these short comings; it mandates the pharma supply chain to be completely interoperable by 2023, allowing traceability down to an individual unit. The article talks about this ‘Track & Trace’ requirement and defines a digital solution to full the interoperability requirement.
Content
Pharma supply chain comprises of manufacturers, CFA. Distributors, retail pharmacies and eventually the consumer. This supply chain is fragmented and non-interoperable. As a result, counterfeit drugs easily creep into the supply chain impacting not only the pharma revenues, drug recalls but also patient outcomes. In the US, Drug Supply Chain Security Act was made into a law in 2013 to address these short comings; it mandates the pharma supply chain to be completely interoperable by 2023, allowing traceability down to an individual unit. With this regulation, all the key stakeholders such as Manufacture, Repackager, Wholesale Distributor, 3PL provider, and Dispenser would be part of an interoperable ecosystem with a focus on sharing Transaction Information, Transaction Statement, and Transaction History referred to as T3.
Based on our deep Industry experience, Coforge provides guidelines for the solutions which can enable supply chain visibility, ensure authenticity checks, is scalable and improves customer brand experience. The guidelines for the Solution are –
Track & Trace – Solution should be able to fulfil serialization requirements across all pharma drugs at a unit level, primary packaging level, secondary packaging level as well as pallets. These solutions should be compatible with high-speed artwork printers/ their middleware or propose changes to production line with minimal disruption
Authenticity – Solution should be able to drive ‘Authenticity check’ to distinguish a fake drug for a genuine one. Multiple technologies like numeric hash, Blockchain, invisible cryto signatures are available. Technologies which deter imitability, should be preferred. Blockchain and invisible crypto signatures are the most difficult to track of the available technologies.
Encoding - QR Code/ Bar Code – The Solution should be able to generate QR codes/ barcodes in real time for all units, including primary & secondary packaging to be applied on artwork. This system should be integrated with the Serialization software /middleware.
Patient App/ Website – The customer App/Portal should be available for seamless digital experience enabling easy validation of a drug with the manufacturer along with empowering the stakeholders with complete visibility of the supply chain in order to comply with DSCSA regulations. This app/ portal should open post scanning of the QR Code/ bar code.
Dynamic branding Content – Branding / Labelling / Therapeutic content should also be made available as part of the patient app / website to the customer. This page/site can contain details like – Usage, Safety Instructions, Storage Instructions, Videos, Patient Support Programs details, etc which provides more engaging content for the patient.
Provisioning – For all active supply chain partners like CFA’s, distributors, retailers, pharmacy’s, digital solutions like app/ web portal should be provided for recording the delivery acceptance. This helps to trace the journey of the drug till the last mile.
Reporting – The functionality of reporting spurious /counterfeit goods should be made available. This can happen through the patient app/ portal. Typical image of the packaging, email, and geography should be captured while recording the complaint. For non-users, like HCPs & Caregivers, who might not scan the QR code, but still must report counterfeit’s additional avenues like web portals, call enters, should be made available
Dashboards – Dashboards and Reporting facility should be part of this solution. Most common dashboards are Geographic distribution/ insights on the incidents raised on the basis of region, category, and product. Supply Chain Visibility Dashboard to enable Track & Trace of drugs.
Conclusion
Counterfeit drugs pose significant risks to both patient safety and pharmaceutical revenues. Implementing digital solutions for track and trace, such as serialization and blockchain, can ensure the authenticity of drugs and compliance with regulations like the Drug Supply Chain Security Act. Coforge’s expertise in the pharma value chain, combined with partnerships with leading vendors, enables the creation of comprehensive solutions for counterfeit management. Embrace these technologies to enhance supply chain visibility, improve patient outcomes, and safeguard your brand.