According to a recent supplement of the American Journal of Tropical Medicine and Hygiene, between 9 and 41 percent of medications in a sample of 16,800 drugs fell short of meeting quality standards. In an industry whose offerings include lifesaving drugs, substandard products put the public health at risk—and the stakes couldn’t be higher. In a foreword to the supplement, former FDA Commissioner Margaret Hamburg writes, “Substandard and falsified medical products pose significant risks to global health with potentially devastating and far-reaching consequences.” The crux of the problem is a lack of visibility along the supply chain, which can lead to these vulnerabilities.
The scale of the issue is global. Hamburg writes that globalization “has redefined the field of medical product regulation by adding layers of complexity to the supply chain and creating opportunities for the potential contamination and/or intentional adulteration of the ingredients and finished products that pass through its links.” She continues to call for “global quality and safety oversight” to protect patients from falsified products. In an effort to guard the life sciences supply chain against counterfeit and substandard products, governments around the world have enacted new regulations.
Regulatory Compliance: A Painful Necessity
Among those regulations, the FDA’s Drug Supply Chain Security Act, Title II of the Drug Quality and Security Act, “outlines critical steps to build an electronic, interoperable system to identify and trace certain specific drugs as they are distributed in the United States.” The new regulatory requirements for pharmaceutical manufacturers began rolling out earlier this year, with a timeline that extends to 2023.
While designed to protect the supply chain against counterfeit drugs, among other issues, mounting regulations lead to other challenges for supply chain practitioners. The seventh annual UPS Pain in the (Supply) Chain survey, published in September 2014, reports that regulatory compliance continues to be the top pain point for logistics executives in the healthcare supply chain. Of the 536 senior-level supply chain leaders surveyed, 60% reported regulatory compliance as the highest rated concern.
Another challenge noted in the survey: “poor supply chain visibility.” In the life sciences industry, supply chain visibility and regulatory compliance go hand in glove. Tracking product from manufacturers, to repackagers, wholesale distributors and dispensers is both a regulatory requirement and a key component to supply chain visibility. And with a traceable chain of custody from end to end of the supply chain, pharmaceutical companies stand a much stronger chance of protecting themselves from counterfeits.
Track and Trace—And Take Action
With the right technology and processes in place, life sciences companies have the visibility to support traceability of products throughout the extended supply chain while meeting regulatory requirements. Practices like serialization and lot tracing ensure that companies know the origin of every product down to the smallest saleable unit.
Of course visibility is not the complete answer to safeguarding the supply chain against counterfeits. Companies must be able to take the next step and execute transactions with meaningful data. Clifford Hallam Healthcare (CH2), Australia’s leading healthcare supplier, implemented DSI’s digital supply chain solutions to execute the company’s 10-year plan to create traceability throughout the life sciences industry.
“We now scan everything —products, people, printers, pallets,” says Ged Halstead, Chief Information Officer, CH2. “DSI enabled our company culture of accountability to become reality. Every transaction is logged, which enables full accountability and encourages responsibility. This technology gives our workers a sense of ownership, and clear processes give them confidence.”
Stories like this demonstrate how life sciences companies can leverage technology to protect supply chain integrity and ensure a secure chain of custody down to the last mile. Read the full success story to learn more, and keep exploring dsiglobal.com to find out how our extended supply chain solutions can empower companies across a wide variety of industries to gain complete supply chain visibility, execution and business process optimization.