June 14, 2024
Pharmaceutical Traceability

Enabling Pharmaceutical Traceability Through Digital Transformation

Need for Pharmaceutical Traceability

The pharmaceutical supply chain is complex with products changing multiple hands from manufacturing to the patient. Ensuring every drug’s authenticity and journey is critical for patient safety. However, traditionally traceability in pharma has been a challenge. Drugs can get contaminated, expire or be counterfeited without detection at each supply chain stage. This poses serious risks. Traceability solves this by digitally tracking every product unit right from origin.

Current Challenges with Traceability

Pharma companies currently use techniques like serialization to uniquely identify drug packs. However, tracing the full journey still has gaps. Pack-level data is often captured manually using basic technologies like barcodes. This data is not digitally shared between partners in real-time. As a result, when issues occur, it can be difficult to pinpoint the origin quickly. Lack of standardized traceability systems between countries further complicates global supply chains. Partial or inconsistent data makes recalls and investigations lengthy and expensive. Counterfeiters also exploit these traceability weaknesses.

The Role of emerging Technologies

Next-gen Pharmaceutical Traceability solutions leverage technologies like blockchain, IoT and cloud to digitally transform traceability. Drugs get smart serialized identities using techniques like DNA marking. Partner systems seamlessly exchange encrypted traceability events on a shared distributed ledger in real-time. This records the complete pedigree from raw material to the patient. IoT-enabled logistics monitoring complements this end-to-end visibility. When combined with analytics, these technologies empower early detection of supply chain disruptions, speedy investigations and targeted recalls. They essentially build supply chain resilience through transparency.

Building Pharmaceutical Traceability Infrastructure

Successful implementation begins with establishing standards. Universal product identifiers, core data elements and technological protocols need defining in collaboration between stakeholders. National agencies are driving these through initiatives focused on security, interoperability and data protection. Focus is also on piloting projects and gradually onboarding partner ecosystems onto integrated platforms. Cloud-based shared networks are leveraged for connectivity. Investments are being made to install necessary hardware, train workforce and integrate legacy systems. Regulatory push with compliance mandates furthers technological adoption. The aim overall is building an end-to-end regulated digital infrastructure to support global traceability.

Real-time tracking from manufacturing

Digitization starts from within manufacturing facilities. Serialization solutions electronically label and package-code drug batches. Manufacturing equipment, inventory and environmental conditions are digitally monitored. Real-time production and batch data is recorded onto the blockchain network for perpetuity. This establishes proof of authenticity. Radio frequency identification (RFID) and sensors provide continuous visibility of WIP, shipments and warehouse transfers. Any anomalies are rapidly flagged to investigators from enterprise resource planning (ERP) and manufacturing execution system (MES) integration.

Supply chain event exchange

Once released, digital handoffs seamlessly occur between trading partners’ track and trace systems. Encrypted serialized product data along with custody events sync across distributed ledgers in real-time. During transportation, IoT telematics transmit active location, temperature, light and vibration indicators of loaded shipments. Smart containers complement this monitoring. Arrivals into supplier, distribution center or hospital pharmacies are automatically logged with timestamps. Stock rotations and expiry status also updates transparently. Suspect counterfeits can be identified from unmatched or manipulated events.

Pharmacy-level visibility

Before patient dispensing, pedigree reconciliation at pharmacies validates product authenticity and integrity. Digital proof from source all through the chain is verified automatically. Clinically relevant usage by healthcare practitioners too records onto the ledger. When administered to the patient, final dispense events update prescription history in a personal health record. Recalls are now a click away to precisely target affected stock and patients. Overall transparency across the continuum helps optimize inventory, prevent diversion and facilitate post-market oversight for patient outcomes.

Realizing opportunities

Gradually pharmaceutical traceability systems are addressing past limitations and gaining momentum. The opportunities are immense Рfrom enhanced safety and quality to improved operational efficiencies. Analytics quantify supply chain performance, predict demand, optimize utilization of assets, and streamline complex workflows involved. Counterfeiting losses are curbed while being future-ready for emerging challenges like pandemic disruptions. Most importantly patients have more confidence knowing authenticity and integrity of their medications. When combined with personalized healthcare, traceability helps revolutionize the industry’s relationship with the consumer

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it