Preparing for Change in the Chain of Custody


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When the Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act, was signed into law by President Obama in November 2013, it was clear that big changes would need to happen within the pharmaceutical supply chain over the following decade. In an effort to secure the supply chain, the DSCSA “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” It requires many key players in the supply chain – drug manufacturers, wholesale drug distributors, re-packagers and dispensers – to work with the FDA to help develop the new system, and will require significant attention from all parties to improve the chain of custody process and ensure compliance. 

I recently had the opportunity to talk with Beth Goodbaum at Inbound Logistics to discuss how companies involved in the chain of custody are racing against time to implement new processes and procedures as the DSCSA is enacted for her article “The Race is On: Chain of Custody in the Pharmaceutical Supply Chain.” In our conversation, we talked about how good companies sometimes make bad decisions when attempting to expedite steps within the chain of custody. With this in mind, it’s worth reiterating a few key points that surfaced. 

In my experience working with healthcare companies, I’ve seen two primary pitfalls in the chain of custody process: one being poor planning horizon and the other being resourcing. For example, companies know that they will be required to report a piece of information by a certain date in two years. But instead of developing a plan early, companies procrastinate due to a lack of resources. The result is serious time compression, which is often the impetus for jumping into a solution that’s not quite right.

Many companies don’t even take the time to apply the right resources to defining the requirements. To avoid this all-too-common mistake, organizations should invest the time to clearly understand the requirements of the problem, analyze their own capabilities and examine the technology and the people supporting it. This will help determine if their current process is sufficient or if it needs to change.

Oftentimes, however, those who develop complex solutions are too close to the challenges to be objective. This is where third-party partners can add additional value. As all partners are not created equal, companies must be careful to fully evaluate their offerings. Many large companies rely on a strict RFP process to vet providers, but a poorly constructed RFP will lead to a poor outcome. I can’t tell you how many times I’ve received an RFP from a company that says it needs a response in two weeks, will make a decision in 30 days and wants to be up and running in 60 days – though this timeframe is unrealistic. Complex processes can take 90 to 120 days to implement alone. 

The bottom line is that the supply chain needs to take a strategic approach to strengthen the chain of custody and meet the requirements of the DSCSA in short order. By investing time and resources up front to clearly understand how the Act will affect their company, develop a proactive plan and engage outside support as necessary, organizations can beat the clock and get ahead of these challenges.

To read the full Inbound Logistics story, click here.

Have you begun preparing for the DSCSA? Tell us how by leaving a comment below.