Cure for the Common Cold Chain Break - Pharmaceutical Executive

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Cure for the Common Cold Chain Break


Pharmaceutical Executive


The Healthcare Worker Conundrum

Some temperature monitoring devices are shipped in the product packaging to monitor temperature during various segments—but not during the entire journey. Others report temperature excursions at various points during transportation, but lack the capacity to track combined heat exposures over time that might cause heat damage.

In more than 80 countries, cumulative heat-monitoring devices are used on individual units; they stay with the medicine from start point to end point. Each is equipped with an indicator so healthcare workers can easily identify whether product has accumulated exposure of temperatures over time that may have caused heat damage.

This technology is available in the US but thus far is not widely used.

It is also important to note that temperature excursions occurring during the cold chain journey do not necessarily translate into temperature damage. Many products can tolerate multiple excursions. However, too many excursions outside the required temperature range, and for too long, may cause irreversible temperature damage.

On a global level, extreme climate conditions and unsophisticated refrigeration systems pose significant challenges to cold chain processes. To address this clear threat to the success of immunization programs in developing countries, UNICEF and the World Health Organization first mandated that miniaturized vaccine vial monitors be affixed to individual vaccine vials distributed through their programs in 1996.

The HEATmarker devices used in these programs provide consistent, cumulative, unit-specific temperature monitoring, and include an indicator that shows whether the product has been exposed to potentially damaging temperatures. Since 1996, more than 3 billion HEATmarkers have been affixed to every vaccine distributed globally through UNICEF. Today, 37 global vaccine manufacturers use HEATmarker vaccine vial monitors.

Here, however, a gap persists between the perceived need for such indicators in a developed country such as the US, and the reality of patient risk and product waste associated with cold chain breaks.

Physicians who regularly handle cold chain medicines are looking for a better way. More than four-out-of-five physicians (89 percent PCP/pediatricians and 87 percent specialists) agree on the importance of a device affixed to individual units that indicated whether a product has been exposed to potentially damaging heat.

It's time for the US industry to acknowledge domestic cold chain issues, take a look at technologies used successfully at a global level, and ascertain their value to the healthcare community here. Equipping healthcare workers with the information they need to manage their temperature-sensitive medicines and ensure the thermal integrity of these products helps everyone.

Ted Prusik, PhD, is Senior Vice President of Temptime Corp. He can be reached at


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