The extra mile: Discussing temperature-related issues in pharmaceutical delivery and storage

‘Last mile’ transportation and subsequent user storage conditions present unique challenges when it comes to ensuring the safe and effective use of pharmaceutical products.

Temperature monitoring group Berlinger says the industry faces a need for improved temperature management of drugs, especially vaccines and biologics, during and after the final stages of transportation to the user.

The firm has also 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.

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, according to Berlinger. 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, explained: “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.”

The white paper comes as a new initiative, Team-Up, is launched to encourage the uptake of technology to improve pharmaceutical logistics. Speaking at the recent IQPC Coldchain Logistics Summit in Toronto, Team-Up’s Alan Kennedy stressed the need for the pharma sector to embrace some of the supply chain concepts that have proved transformational in other industries.

Introducing the initiative, which is a collaborative project, Kennedy pressed his proposition by describing some of the approaches to logistics that are the business signatures of leading companies such as Amazon, Apple and Inditex.

“The common denominator in all these ground-breaking supply chain platforms is collaboration,” Kennedy said. “By taking a lead and driving supply chain integration, pharma companies can position themselves to better assimilate technology, drive efficiency, facilitate transparency and, ultimately, deliver improved, safer, outcomes for patients.

“The sector lacks a common platform to underpin collaborative working and enable supply chain integration”, Kennedy went on to describe how the TEAM-UP pharma-logistics collaboration programme has been designed to fill this need.

Based around three ‘pillars’ (community, resources and accreditation) Team-Up has been conceived as a not-for-profit body fostering win-win collaboration and integration between all stakeholders in the pharma-logistics supply chain.

Co-presenting with Kennedy at the IQPC event was Dr Andy Akrouche of the Institute of Collaborative Working in Canada. Akrouche acquainted the audience with the new ISO 44001 international standard for collaborative working. “The Team-Up programme is aligned with the new ISO standard and provides pharma companies and their logistics partners with a structured route to its operational execution.”