The pharmaceutical supply chain is complex with products moving through multiple stages from raw material sourcing to manufacturing, distribution and finally to the patients. With threats of counterfeit drugs and issues of drug diversion, it is important to have complete visibility and traceability across the supply chain. Pharmaceutical traceability ensures that drugs are authentic and can be traced back to the origin, thereby safeguarding patient safety.
Need for Pharmaceutical Traceability
One of the major challenges faced by the pharmaceutical industry is the threat of counterfeit drugs. It is estimated that counterfeit drugs cost lives of over $75,000 people annually. These counterfeit drugs may contain wrong or no active ingredients and can severely harm patient health. Pharmaceutical traceability helps in verifying drug authenticity and identifying sources of counterfeit drugs in the supply chain.
Traceability also helps in addressing issues of drug diversion. Sometimes drugs are stolen or diverted from the regulated supply chain and sold illegally. Such diverted drugs may reach patients with expired dates or under unsuitable storage and transportation conditions. Complete traceability helps track diverted drugs and plug supply chain loopholes exploited by drug diverters. This ensures drugs always remain under regulated supply conditions.
Drug Recalls and Expiry Management
Drug recalls are necessary when problems are detected with specific drug batches post marketing. Without proper traceability, it becomes difficult to identify the scope of affected batches and geographic regions where recalled drugs may have been distributed. This can compromise the effectiveness of drug recalls.
Traceability is also crucial for managing drug expiry. Being able to track drug batches throughout their shelf life enables distributors and pharmacies to efficiently pull out expired drugs. This prevents dispensing of drugs that have crossed their expiry date to patients.
Digital Traceability Technologies
To achieve the level of traceability required in pharmaceutical supply chains, digital technologies are increasingly being utilized. Pharmaceutical Traceability systems use barcode scanning, RFID and blockchain to capture critical events associated with drugs like manufacturing, shipping, receiving and dispensing.
Barcode and RFID scanning helps track individual drug packages through the supply chain. The captured data when combined with blockchain provides a distributed digital record or provenance of drugs across entities. This data gives complete transparency and visibility into the journey of drugs – a core tenet of pharmaceutical traceability. Such advanced traceability technologies establish drug authenticity and help address issues of counterfeiting, theft, diversion and expiries.
Compliance with Regulations
Proper traceability is foundational to comply with regulations around drug authentication and safety. Important regulatory frameworks like the Drug Quality and Security Act (DQSA) in the US and Falsified Medicines Directive (FMD) in the EU mandate implementation of traceability systems by certain deadlines.
Non-compliance can attract hefty penalties and reputational damage. Traceability helps demonstrate due diligence and regulatory conformance. The data collected also supports regulatory inspections by enabling instant drug history lookups across markets and jurisdictions. This brings much needed regulatory oversight over global pharmaceutical supply chains.
Challenges in Implementation
While pharmaceutical traceability brings immense benefits, its effective implementation also faces unique challenges. Industry fragmentation, with multiple trading partners involved makes standardization and system integration difficult. Data sharing between competitive companies is another challenge area.
Resistance to change from entities used to traditional processes can delay technology adoption. Lack of stakeholder collaboration to develop common traceability standards impedes progress. Geopolitical differences across markets introduce further complexities. Privacy and data security with real-time sharing of sensitive tracking data are also important considerations.
Overcoming the technology, process and collaboration hurdles would be key to fully unlock traceability’s potential. With commitment from governments and industry, these challenges can be addressed to strengthen supply chain resilience and enhance patient outcomes globally.
Pharmaceutical traceability brings transparency right from raw material sourcing to the patient. It plays a pivotal role in addressing risks of counterfeiting, diversion and expiries while facilitating regulatory compliance. Though implementation challenges exist, ongoing advancements in digital tracing technologies and global stakeholder cooperation are helping realize traceability’s strategic importance for patient safety. With enhanced traceability measures, the pharmaceutical supply chain of future will be more resilient and trustworthy.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it