When I was a kid, my mother used to bake our annual Easter dinner ham in two separate pans. Shortly after my sister Sheila married, she invited my parents over for a ham dinner. When my mother asked Sheila why she cut the ham in half and baked it in two dishes, my sister replied, “That’s the way you always prepared it, mom.”

My mother responded, “The only reason I did that was because we were a family of nine and I didn’t have one pot big enough to fit the entire ham!”

It’s funny how we are conditioned to follow what we’ve been taught or told, without challenging why, and how complacent and even reluctant we are to change.

Take the world of perishable cargo. In the airline industry the term “perishable cargo” is very broad and consists primarily of high cubic volumes of fresh fruits, flowers, vegetables, fish, meat, and live animals. Almost as an afterthought time- and temperature-sensitive medicines have been lumped into this category as well. That’s the way it’s always been. But herein lies the problem: drugs are not perishable in the same sense that a cabbage is perishable, or that puppies are perishable, and therefore cannot and should not be defined as such or handled in the same manner. Webster’s defines perishable as: “things, especially foodstuffs, likely to decay or go bad quickly.” Unlike “foodstuffs,” drugs have considerable shelf life generally lasting months to years — unless, of course, they are subjected to harmful exposures such as temperature abuse. Then they do not “decay,” as is obvious with fresh cut roses, or “go bad quickly” like odoriferous salmon, but invisibly and imperceptibly degrade, losing potency and efficacy, which can lead to insufficient protection against a disease or treatment for a condition to the eventual recipient of the end user. This is a critical difference. I worked for a pharmaceutical manufacturer for 26 years; in all that time I never once heard anyone in that industry define or describe their products as perishable.

To compound the problem, box manufacturers have historically printed “perishable” or nebulous instructions like “refrigerate upon arrival” and “open immediately” on the outside panels of their insulated shippers used for drug products. And, historically, drug shippers used them. Not until they began to understand and control their shipping practices did they realize the potential harm this can cause the drug product in transportation.

Then, there is the question of what “refrigerated” means. Turns out it means a lot of different things, depending on what standard you reference. In the world of drug manufacturing it is universally understood and accepted that refrigerated means: “any temperature not exceeding 8° C. A ‘refrigerator’ is a cold place in which the temperature is maintained thermostatically between 2° and 8° C.”¹ However, in the airline industry, cold is defined as: -9° to +2 °C.²

To help minimize the confusion in standards and vagaries of communication, the airline industry, through the efforts of the International Air Transport Association (IATA) Time and Temperature Task Force (TTTF), adopted the use of a unique and universally accepted shipping label formally known as the Time and Temperature Sensitive Label for Healthcare Products. The label was first introduced in 2010 and became mandatory July 1, 2012 for all shipments booked as temperature controlled healthcare cargo. Among the airlines’ requirements for use of the label are: “the lower half must be used to indicate the external transportation temperature (allowable temperature range or limit that the package can be exposed to during transportation).”³

IATA has been actively promoting the use of the label at industry conferences; last February in Basel, Switzerland, Andrea Gruber, secretary of the IATA Perishables Cargo Board and the Time and Temperature Task Force, said, “About 70% of healthcare shippers are currently using the label.” However, recent temperature data from a years’ worth of international shipments from at least one top 10 pharmaceutical company reveal that, despite religious use of the label for designated healthcare products, improper storage, mishandling and exposure to excessive and harmful temperatures are still occurring at an alarming rate while the shipments are in the care and control of the airlines.

This is not to say that mishandling and variability in temperature is not occurring at other points in the transportation chain, because it most certainly is, but a review of the data from more than 800 shipments clearly indicate that the highest and most frequent exposures to temperatures above 40°C over the entire transit repeatedly occurs on the tarmac — pre-flight, at transit airports prior to their onward flight to their final destination. The data also show that storage at 5°C at transit airports as well as final destination airports occurs on a regular basis, especially at hot locales; most notably Saudi Arabia, Venezuela, Argentina, Singapore and India. More moderate climate destinations like Canada, South Africa and New Zealand also show storage at 5°C, but less frequently.

Major contributors to this disparity in temperature include the lack of proper storage facilities on-site at airports and inadequate understanding of temperature-sensitive healthcare products by ground-handling personnel. Fortunately, the growth in pharma products and the lure of high freight margins on pharma cargo are beginning to result in airport and air carrier facility investments.

One of the most elaborate expansions is in Luxembourg where LuxairCargo has recently opened a $5 million GDP-compliant Pharma & Healthcare Center, separate from its other “perishable” cargo. IAG Cargo broke ground in July on the site of its new, dedicated Constant Climate Centre at London’s Heathrow hub — again, separate from its enormous perishables facility. Both projects have expansive and validated 2 to 8°C storage capabilities and 15 to 25°C CRT facilities, and both seem to understand the requirements for delineating between perishables and healthcare freight. Ethiopian Airlines opened a new cold storage facility in Addis Ababa last March and similar projects have recently been completed in Hong Kong and Dubai. Baby steps.

Despite these efforts, training continues to be a huge hurdle. Although IATA provides a classroom training option specific to Chapter 17 of their Perishables Cargo Regulations, there are few participants. Scheduled classes are cancelled more often than not due to lack of enrollment. IATA has yet to define how it will enforce its own regulations with regard to mishandled temperature-sensitive healthcare shipments. It’s a premium service and shippers expect to get what they pay for.

Still, planning, protocols and payment can only go so far. There is no substitute for conscientiousness and proper handling by ground agents. They are perhaps the most critical component of all. Yet the ground-handling industry continues to be an outsourced service for most carriers, suffering from high turnover and a lack of knowledge and expertise on healthcare, as the data reflect. This combination of ignorance and instability continue to keep shipments at risk and shippers exploring alternatives modes of transportation.

Time and temperature-sensitive healthcare products suffer a certain stigma classified as perishable cargo, that left unchallenged, will probably never change in the airline industry. Splitting the ham into two pots is no longer acceptable. It is time for a change. 

References

1. Unites States Pharmacopeia, USP 32, General Notices and Requirements. Section 10.30.20
2. IATA Perishable Cargo Regulations, 13th Edition, Chapter 5.1.1.4.
3. IATA Perishable Cargo Regulations, 13th Edition, Chapter 17.10.6.1.