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.
Pharmaceutical track and trace legislation has arrived. Signed in 2013, Title II of the Drug Quality and Security Act outlines specific steps to build an electronic system to track and trace prescription drugs in the U.S.
Many U.S. state regulations for pharmacies recommend monitoring prescription refrigerators and freezers twice per day, manually. This entails, a pharmacist reading a thermometer inside a fridge or freezer and recording it on a paper log, at the beginning and the end of the day. These daily logs are kept in files at the pharmacy for review during inspections.
Many pharmacies, medical offices, and health clinics manually monitor temperature twice per day using a paper log. If the temperature at the time of the reading is within the desired range, 36°F - 46°F (2°C - 8°C) for refrigerators, -50°C - -15°C (-58°F - +5°F) for freezers, no action is taken.
Remote Monitoring is making its way into all aspects of business. None is more important than ensuring the quality and safety of refrigerated medications.
At the end of June 2016, the U.S. Center for Disease Control (CDC) released an updated Vaccine Storage and Handling Toolkit. Among the most interesting changes is the new recommended Fahrenheit temperature range for refrigerated vaccines. The Fahrenheit temperature range for refrigerated vaccines was updated from 35°F - 46°F to 36°F - 46°F. The Celsius temperature range remains unchanged: 2°C - 8°C.
