Beyond Track and Trace

In our last post, we gave an overview of track and trace. This legislation is a critical step to improving the safety and efficacy of prescription drugs in the U.S. However, it alone may not be sufficient for all medications. In addition to trace and trace, manufacturer’s will need to consider cold chain custody tracking of temperature sensitive medications such as vaccines or insulin.Cold chain custody records are necessary to prevent temperature sensitive medications from losing efficacy or from becoming unsafe. Continuous temperature monitoring of refrigerated and frozen medications is necessary at the following points in the cold chain:

• Manufacturing Facilities
• Warehouses
• Distribution Sites
• Transportation
• Retail Locations, Hospitals, and Medical Offices

For recommended temperature storage guidelines, see the Center for Disease Control (CDC) Vaccine Storage and Handling Toolkit (June 2016).

Track and trace provides a level of safety that helps ensure medications are authentic. Continuous cold chain monitoring provides an additional level of safety that helps assure refrigerated medications are safe and effective.