Dedicated To Improving Pharmaceutical Cold-Chain Distribution Practices
View Article  Webinar: Global Cold-Chain Regulations Influencing Logistics of Clinical Trial Materials

There is a free webinar April 24th, 2007, hosted by Sensitech focusing on protecting clinical trial materials through the global distribution environment.

The presentation will feature two speakers: Dr. Rafik Bishara, an industry technical advisor, who will review global regulatory and standards-based guidance for Good Cold Chain Management Practices, and Michael Connolly, Director of U.S. Operations for World Courier Inc., who will highlight practical applications of these regulatory requirements.

You can link to their website for further details and registration here. http://www.sensitech.com/about/events/webinars/globalCC_ctm/registration.html

View Article  Redefining Perishable Freight to Improve the Delivery of Healthcare Products

It became clear to me over the course of the three days at the IATA World Cargo Conference in Mexico City that pharmaceuticals, diagnostics, vaccines, insulin, devices and other medicinal products requiring temperature control during transport should not be lumped in with all other 'perishable' freight. Several speakers made the distinction as well - defining processes, handling procedures and logistics often with the caveat "except for pharmaceuticals, of course."

Delineating the two can only lead to an improvement in the way temperature-sensitive healthcare items are handled by the airlines. According to IATA, nearly 95% of perishables freight handled by their member airlines are fruits, vegetables, flowers, seafood, meat, plants and live animals. Healthcare products represent less than 5%. Yet the two are often handled the same. Clearly, they have very different handling requirements.

Most perishable freight - fruits, vegetables, flowers and other plant material cannot utilize the same type of hermetically sealed packaging common in the pharmaceutical industry  due to their metabolic nature of generating heat as they ripen, mature and bloom. Distribution and transport of these items rely heavily on a complex system of refrigeration at each touch point: picking, packing, pre-cooling, vented packaging, refrigerated truck transport, and so on, from grower through to the end user.

Christine Boldt, Executive Vice-President, Association of Floral Importers of Florida mentioned in her keynote address at the symposium that from vine to vase fresh-cut flowers can experience as many as 102 hand-offs - each with a potential to temperature exposure that can affect the longevity and quality of the bloom.

It should be noted that refrigeration storage at airports, where available can vary widely in size, quality and range and are not always on site or controlled by the airlines. Flowers, for example, are stored between 0-4C while other material may have a range of 10-15C. So, the set point can be arbitrarily changed depending on the quantity and priority of material stored. Even the word refrigerate is ambiguous. In some countries, for instance,  a refrigerator is a device that keeps items frozen.

The pharmaceutical industry has taken it upon themselves to avoid this potential risk and variability of global distribution by developing complex and robust packaging in order to protect their product and their revenue - lest a well intentioned ramp worker  expose pharma freight, packaged to meet the requirements of a normal distribution environment, to refrigerated temperatures. The result can be devastating and long-reaching. 

When a 'perishable' such as fish or vegetables are exposed to temperature abuse in transport, the proof is obvious, visually and aurally. It is nearly impossible to use the same measure to tell if the safety, quality or efficacy of a drug has been affected. This is a critical difference.

Drug companies, by-and-large are aware of these pitfall of transportation and in an effort to avoid them have resorted to applying a vast array of labels, placards, special instructions and procedures that may or may not be seen or heeded by cargo personnel at airports.

Both sides come away from the entire experience frustrated. Each needs to have a better understanding on how the other operates - their requirements, their limitations and their expectations. A mutually agreed upon handling label could help, as could separating healthcare freight from all other perishables in definition, perception, and handling. The result would help to provide higher quality, safer and more efficacious drugs to those who need them.