December 2013 | Commentary | Viewpoint

Pharmaceutical Supply Chain Tackles Track-and-Trace Challenges

Tags: Logistics I.T., Pharmaceutical Logistics

Tim Conroy is General Manager, International Business Systems (IBS Americas)

New legislation is in the works to prevent counterfeit medicines from entering the pharmaceutical supply chain. These random mixtures of harmful toxic substances are not only illegal; they are extremely dangerous to patients and damaging to the reputations of legitimate pharmaceutical companies.

Increased Internet sales, widespread demand for generic drugs, and drug shortages in many countries and market segments fuel the counterfeit drug trade. As governments worldwide scramble to respond, counterfeiters change their methodologies, moving operations or re-routing supplies to circumvent detection.

Government agencies are working to institute a comprehensive track-and-trace system to monitor drugs throughout the production and distribution lifecycle. From now through 2017, when a majority of these proposals are set to become law, organizations throughout the pharmaceutical supply chain will need to begin implementing systems that offer a combined process and technology approach to tracking and tracing drugs.

A key part of these systems is recognizing all regional standards for coding, capture, and data exchange. In addition, the systems must be able to manage the process even when repacking and exceptions occur. Therefore, data access must be enabled across the supply chain through Web portals, and to the specific business-to-business standards used by all partners.

Other core capabilities include rebates, contract administration, chargebacks, pricing, recalls, expiration handling, and non-saleable merchandise.

Automated tracking systems must also be able to manage the serialization process cleanly. This includes generating lot data on bar-code labels for real-time tracking through full-cycle receiving, quality control, putaway, replenishment, counting, and pick, pack, and ship operations. The system must store and format the data to record item, lot, and warehouse history, as well as detailed date, time, and user information for tracking reports.

A system that automatically alerts users of out-of-bounds instances (for example, when items don't match batch tickets) will also reduce liability and enhance supply chain throughput. The ability to manage multiple expiration dates for the same product is also essential so the operation can support a first-expiring/first-out picking sequence.

A full system response should provide a functional controlled-substance ordering system—including suspicious order monitoring—with the comprehensive electronic reporting and coding capabilities to report all required data electronically, in compliance with regional regulations.

A Sensible Solution

An automated, supply chain solution specifically tailored to your pharmaceutical business will deliver value on a number of fronts. In addition to holding your organization confidently within the boundaries of compliance, a reliable track-and-trace drug monitoring system will enhance efficiency, speed delivery, reduce cost-to-serve, eliminate waste, provide visibility into your expanded network inventory, improve forecasting, support sales, improve margins, build brand loyalty, and create brand differentiation.

A well-conceived track-and-trace capability will improve automation, visibility, efficiency, and profitability across the supply chain while protecting your brand—and the general welfare. It's a win all the way around.