As new federal track and trace requirements begin rolling out, the pharmaceutical supply chain confronts the challenge of managing a flood of data. The pharmaceutical supply chain moves billions of dollars worth of drugs and medical products each year in the U.S. alone. Like other supply chains handling high-value, time-sensitive goods, it faces increasing demands from shippers and consignees to maintain product integrity, and from the federal government to comply with regulations. All the while, it is striving to prevent theft and counterfeiting. The financial impact is enormous. The flow of counterfeit pharmaceuticals is on pace to equal 5 percent of the global drug market by 2016 and to cost the pharmaceutical industry about $70 billion in worldwide sales, according to a 2013 study, "Building New Strengths in the Healthcare Supply Chain," by consultancy McKinsey & Co. But the problem goes beyond money. People suffering from diabetes, heart disease, HIV, and other diseases can become seriously ill if their medication lacks therapeutic value because it is fake or stale. The solution to the twin challenges of improved compliance and reduced counterfeiting may lie with improving the supply chain’s track and trace capabilities, an obligation that will fall partly on the shoulders of logistics professionals. The Drug Supply Chain Security Act (DSCSA)—a section of the Drug Quality and Security Act (DQSA) of 2013—calls for the 10-year phase-in of an array of requirements that will lead to the creation of an electronic track and trace system. Through this system, the Food and Drug Administration (FDA) will be able to pinpoint the location of any drug throughout the supply chain and drill down to the individual package level. However, few in the field understand how to manage the flood of data that will need to be generated, stored, and retrieved in support […]
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