New whitepaper on temperature-related problems in drug delivery and storage, from Berlinger

‘Last mile’ transportation and subsequent user storage conditions present unique challenges when it comes to ensuring the safe and effective use of pharmaceutical products. Berlinger & Co. AG, a market leader in pharmaceutical temperature monitoring, has released a White Paper entitled “Beyond the Cold Chain” that discusses the temperature-related problems associated with the delivery and storage of drugs after they leave the primary supply chain.

The paper examines the need for improved temperature management of drugs, especially vaccines and biologics, during and after the final stages of transportation to the user. It looks at typical domestic storage conditions for medicines and the circumstances found in under-developed countries and during humanitarian relief efforts.

According to the author, there is significant risk of therapeutic loss or impairment in the event of unacceptable temperature exposures. In some cases such temperature deviation might not only result in a loss of potency, in some cases it may result in the product becoming dangerous due to the production of toxic degradation compounds.

This is because once a pharma product leaves the controlled-temperature environment of the primary supply chain it tends to enter a ‘grey area‘ where little might be known about the correct handling and storage of sensitive drugs and even less may be known about the consequences of taking thermally-compromised medicines. The results of a recent study of real end-user storage conditions were startling. Out of 255 participants in the study less than 10% had stored their medication within the recommended temperature range.

The white paper goes on to consider the need for cold as well as hot temperature monitoring and the role of the latest generation of micro monitoring devices that can be physically attached to primary packaging.

Poor last-mile temperature management has huge implications for the industry as Berlinger’s Chief Operation Officer, Corneliu Tobescu, explains:

How many drugs are thrown away due to being judged unfit for human consumption at point of use? How many drugs are consumed that are outside the official margins for safety? These are serious issues that to a large degree can be addressed through equipping individual medicine containers with inexpensive, electronic temperature indicators that are accurate, reliable and easy-to-use. Such a safety feature will reduce unnecessary waste and improve curative outcomes.”