If you are a pharmacist working on clinical trials you are probably well aware of the clinical trials drugs temperature monitoring requirements. If you work only with medications that require storage at room temperature (15-30 C), you are one of the few lucky ones. Unless you are in a desert with extreme high temperatures (above 30 C) or in a very cold location (below 15 C) you will not have significant issues to maintain the temperature. 

Unfortunately in many cases clinical trials drugs require storage at lower temperatures (2-8 C). And in this case monitoring drug storage temperature during the study is critical. In general, clinical trials drugs temperature monitoring of refrigerated medications is done in special fridges with temperature devices, which are connected to alarm system in case the temperature goes out of range. If there are temperature deviations, pharmacy team will report it to the Sponsor and quarantine the stock until they receive approval or rejection of the drugs. 

However, this is just the tip of the iceberg. In reality there are other steps that require temperature monitoring and very often the clinical trials teams miss these cases. 

When do you need to monitor clinical trials drugs temperature?

  • Transportation to external facility – Majority of the hospitals uses external facilities for aseptic units for drug preparation. These units are used to prepare cytotoxic drugs. If such facility is used, pharmacy team has to monitor the temperature during transition between the main pharmacy and external facility.
  • Storage at department fridges – In lots of clinical trials the teams use department fridges to store drugs, which are dispensed by the pharmacy and have to be administrated to the patients. It is very common issue that these department fridges are used for storage of different supplies and not always monitored. If you use department fridge, you need to make sure the temperature is monitored regularly and temperature deviations reported to the Sponsor.  
  • Preparation process – Although these are rear occasions, sometimes protocols specify very short preparation timelines. In these cases pharmacy team has to create a local Standard Operating Procedure to explain how they will handle temperature monitoring during preparation.

Before starting a new clinical trial the teams have to establish clear temperature monitoring process and make sure there are no exceptions from this process. Inadequate drug temperature monitoring could put at risk patients’ safety.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 4 Feb 2016