End-to-end traceability in pharma: It’s not just about safety

Enhancing resilience and agility is particularly critical, as the issue of resilience in the pharmaceutical supply chain has ‘elbowed’ its way into the boardroom in the wake of COVID‑19. Executives can no longer ignore the threat posed by the often-tenuous threads of supply, both inbound and outbound, that compromise their end-to-end supply chains.

Full traceability extends the view beyond the lab and corporate walls, to provide insight into the flow of ingredients, drugs, and equipment from their source all the way to clinic, hospital, and pharmacy shelves. Supply chain planners and managers are better equipped to identify potential problems and act early, protecting supply lines and ensuring products flow smoothly to patients and care providers.

The International Institute of Research Against Counterfeit Medicines (IRACM) describes, “The traceability of a product refers to the ability to locate it throughout the complete lifecycle of the production and distribution processes. Traceability plays a major role in the fight against health product counterfeiting.”

The obvious benefits are maintaining the effectiveness of drugs, improving patient lives, and minimising the costs to the industry imposed by counterfeits, substandard drugs, and recalls. But full traceability across a digital supply network can help in other ways too, including:

  • Improving efficiency and minimising waste
  • Enhancing collaboration in the supply chain to resolve inter-enterprise problems better and faster
  • Enhancing resilience and agility to help predict shortages and secure the supply during a crisis

Achieving traceability across the heathcare supply chain

So, how is it possible to realise end‑to‑end traceability? Before value can be gained from full, end-to-end traceability, it is necessary to authenticate the product itself. There is no purpose in tracking a product through the supply chain if the drug itself is substandard or counterfeit. The keys to effective traceability include the following.

Product authentication and serialisation: Product authentication technology is an essential part of a secure drug supply chain, and there are numerous ways to achieve this. Spectrometer analyzers can verify the actual ingredients and dosage of product, but other methods include specially designed coatings, chemical and molecular markers, and micro tags. The latter options can be applied at any and all levels—from the ingredients themselves all the way to the finished drugs and even the packaging. Serialization involves adding a unique identifier to sellable units of the product, so that it can be identified and traced throughout the supply chain.

Legacy technologies fall short: Any drug supply chain is vulnerable to product quality problems, and there is always a chance for variance due to ingredient issues, substitution, contamination, formulation, or just plain human error. Many companies have tried to leverage electronic data interchange (EDI) across the network to address some of these issues. However, as a technology, EDI is woefully inadequate in addressing today’s supply network requirements. Remember, EDI was originally developed during the time of batch business processing and, even with the benefit of some of the newer extensible markup language business-to-business formats; it is still not possible to process much of the product quality related data being consumed through the various Internet of things sensors deployed throughout the network. So, while EDI itself will still remain in the picture for years to come, a supply network platform is needed that will enable continuous digital business processes to provide full traceability and the assurance of product quality and safety.

Identify the root cause of quality issues: When an issue does arise, an effective traceability capability should allow for a root cause analysis at the process level to be performed, which means network level master data management is needed that is extensible across multiple data types and geographic regions. Just like a Single Version of the Truth (SVOT) from a demand signal perspective across the network is needed, so too is a SVOT at the process level from a product quality and safety perspective. In this way, traceability becomes another foundational element of quality culture. Over time, a network platform will become the backbone for the digital twin, including a multi-party ledger (i.e., a blockchain at the network level), which also provides permission-based security between trading partners. Such architecture also opens up the potential to add artificial intelligence (AI) into the mix. A multi-party intelligent agent can operate across the network targeted at improving key metrics such as achieving on-time in-full order fulfilment.

Traceability- The basis for effective execution: When there is a problem with a drug, any missteps in handling the crisis are costly in a social media-driven world where brand damage can happen quickly. In times of crisis, pharmaceutical companies need to respond quickly by:

  • Acting immediately with great transparency
  • Rapidly identifying the scope of the problem
  • Locating the specific drugs,
  • lots, and impacted locations and customers
  • Initiating the recall and executing the recall logistics
  • Identifying the source of the problem and fixing it
  • Instilling confidence in their marketplace and with consumers.

To do all this effectively, more control over the supply network is required. Leveraging network-based technology that tracks the full chain-of-custody for every item from start to finish provides visibility into supply chains with a way to effectively track products, intermediates, and raw materials in real time, from their source, across trading partners, all the way to the clinics, hospitals, and pharmacies who need them.

By rapidly extracting only the affected product in a recall and at the precise locations in the supply chain that are affected, companies can minimise the impact on consumers and healthcare providers, protect their reputation, and minimize costs. Another critical factor is knowing exactly what and how much product needs to be replaced to quickly resupply to locations with minimum business impact.

Brand quality: More than just product quality

Over time, traceability data will enable process improvement and product-quality initiatives. Plus, with AI in the mix, it is also possible to relate changes in process variables to potential outcome, with probabilities measured against acceptable thresholds. But what’s interesting is that today, brand quality extends well beyond product quality.

Understanding and verifying sources and origins: Today, it is more important than ever to know the specific ingredients of each drug and if they are authentic, where they originated, and who made and handled the product. In fact, more and more pharmaceutical manufacturers are being asked to provide and prove the answers to those questions. Using a chain-of-custody solution, raw ingredients, drugs, shipments, and origins can be completely tracked, so that all approved sources of raw materials, intermediates, and finished drugs, as well as their paths through the supply chain network, are 100% verifiable and auditable. This takes on life-saving significance, especially where counterfeit pharmaceuticals are a concern, such as in some regions in Africa. Or, where medical products like biologics, must be maintained at certain temperatures to prevent spoilage or degradation during their journey through the supply network.

Business network platforms exist to support traceability and chain-of-custody: Given the implications traceability has in relation to product quality, safety, and compliance with current and imminent regulations, there really is no choice but to move forward with a technology investment to enable this capability.

The business network not only enables chain-of-custody and traceability services but also provides a foundation for future growth and innovation.

Bottom line

Whether a product quality issue leads to recalls, warranty claims, or unit level medical device repairs, after the event the trust of the patient and healthcare provider will need to be regained. By having the ability to address and communicate a course of action proactively, the overall impact can be significantly limited. Business network technology enables companies to be proactive and more, as it tracks the full chain-of-custody for every item from start to finish, providing visibility across final products, intermediates, and raw ingredients in real time from their source, across trading partners and to the point of care, whether that be a hospital, clinic, or retailer.

By Dr Reddy Gottipolu, SVP- Healthcare at One Network Enterprises

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