When we think cold chain, we most often think of food. However, as the pharmaceutical industry continues its consistent growth, there are more and more drugs being produced which require cold chain services with multi-touchpoints to ensure viability and safety.
Let us take a moment to talk about how this niche has grown and just how the industry is reacting to it.
How Did Cold Chain Pharma Become So Vital?
The most obvious reason is more drugs are being produced which require temperature control while being transported and stored. Former Senior Director of Product Quality Management of Johnson & Johnson, Lisa Forian, wrote that as we enter an age of biologically based medicines, the need to monitor and control temperature sensitivity is increasing because these drugs require more monitoring to ensure their efficacy and safety.
How are Counterfeit Drugs Impacting the Growth of Cold Chain Pharma?
Cold supply chains are helping the FDA suppress counterfeit drugs that have flooded the marketplace. Unsafe, and in most cases, useless, these drugs are being caught before they can do damage due to FDA requirements for a transparent supply chain. Establishing a supply chain with a solid chain of custody creates a “pedigree” of sorts that gives visibility to the process of the drugs from manufacturing through retail distribution. The FDA’s Drug Supply Chain Security Act was enacted in 2013 to “…enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”
How the Industry is Reacting
Logistics professionals who want to work with Pharma need to do three things: learn, collaborate, and pilot. Learning pertains to understanding all the requirements for safe pharma logistics, and engaging in continuous education as the landscape changes. Through collaboration, 3PLs need to work with all partners involved with transparency to model and build supply chains complete with 24/7 tracking. The pilot stage is the commitment to test new options and to execute and monitor every step. It is also critical to carefully and consistently evaluate your performance as well as that of every one of your partners. Obviously, monitoring isn’t enough. You must be willing to make necessary adjustments immediately when shortcomings in your process are identified.
All eyes are now on 3PLs to ensure the safety of our medicines, but also to help protect consumers from counterfeit drugs that could harm them. As pharma continues to grow, that need will only increase. For more information, please contact our team at 855-214-2844.