During the week of September 21-25, I attended and served as plenary chairperson at the 7th Annual IQPC Cold Chain Distribution for Pharmaceuticals Conference in Philadelphia and delivered a presentation at the United States Pharmocopeia Annual Scientific Meeting in Toronto. It was a hectic week.

I always look forward to these events - not only to keep up with what is going on within the industry - but to meet and reconnect with the many colleagues, friends and associates I have had the pleasure to know over these many years in cold-chain - many of whom I get to see only once or twice a year. 

I'd like to apologize to those who attended either of these conferences with whom I might have appeard distant or distracted. I was consumed by a bit of a personal nightmare during that week, a family tragedy which occurred only days before, on September 19th, and it permiated nearly my every thought and action and required considerable time, attention and energy.  

My thanks to those few colleagues with whom I shared this knowledge during the conferences and whose care, compassion, condolences and understanding really helped me get through through a most difficult week.

I have had several delegates at recent Cold Chain Conferences requesting a copy of the 24 Hour Worldwide Air Traffic video which I have included as an introduction to many of my IATA presentations. Here's the link to the Zurich School of Engineering who produced the video. Enjoy!

BTW: Care to guess how many flights this video represents in a 24 hour period?

Answer: Globally, there are approximately 85,000 flights daily!

In an effort to curb pollution from the seemingly ubiquitous white foam plastic coolers abandoned by careless boaters and river-floaters, the Missouri State Legislature inadvertanly banned  the wrong plastic - polypropylene - instead of expanded polystyrene.

The result can potentially land you up to a year in jail if you bring Aunt Millie's potato salad in a Tupperware bowl to a river picnic. The snafu also means that boaters and river-floaters who pollute the waterways with discarded EPS foam coolers can do so without fear of reprisal.

Apparently, show me the difference between PS an PP, was not  stated in the "Show Me State." Missouri Bans Wrong Plastic From Rivers

Last month, Eli Lilly and Company, along with its insurers, were awarded damages from a Florida District Court against Air Express International USA, d/b/a DHL Forwarding, for the mishandling of a temperature-sensitive shipment of insulin. The settlement was in the neighborhood of $10 million.

Lilly was able to document and successfully argue through the use of temperature data loggers that accompanied the product, that seven out of eight pallets in the shipment from Germany to Indianapolis were exposed to freezing temperatures while in possession of its contracted forwarding company, DHL, at Munich International Airport.

DHL unsuccessfully argued that Lilly did not present any admissible evidence of "physical loss" but rather "fear of loss," while experts from Lilly stated that insulin exposed to sub-frozen temperatures may undergo subtle changes that are not necessarily detectable by physical inspection, could prove harmful to the patient if administered, and that confirmation of the integrity of the product could not be performed without being destructively tested.

Rather than award Lilly the customary air carrier damage/loss amount of $4 per kilo, or even go so far as to recoup replacement or manufacturing costs, the Florida Court surprisingly ruled that Eli Lilly was entitled to nearly $10 million from the integrated freight forwarding company, which Lilly claimed was the inter-company transfer price of the product between its affiliates in Germany and the US.

This conclusion is one of the few cargo decisions which effectively confirms that a shipper or consignee is entitled to a certain level of profit in its pricing in its declaration of "loss." Given that the manufacture of drugs has become a multi-national process within companies, inter-company transfer is often the primary means of accounting. And as government regulators continue to dig deeper into the distribution and storage practices of drug manufacturers, the innovators themselves have developed much more sophisticated and complex controls over the distribution process - carefully tracking and documenting every nuance. Subsequently, transport service providers are having to step up their game. But healthcare companies should be careful for what they wish for - claims such as Lilly v. DHL can potentially lead to a virtual halt in healthcare transportation if service providers consider the liability risk too great. They can simply refuse to ship it. Folks, we are at the dawn of a new era.

You can read the entire Alert published by Cozen - O'Connor by clicking on the attachment icon below. 

Among the greatest logistics challenges facing the delivery of time- and temperature-sensitive drugs (TTSD) to remote regions of the world is the disconnect between perceived expectations and responsibilities of those on the front-end of the distribution chain and the reality of those on the back-end. There remains an industry-wide misconception by manufacturers and front-end logistics providers alike, that responsibility and concern for the drugs they manufacture, sell, and distribute, ends at the dock door or at the primary distribution center. Regulators around the world recognize this gap and the need for improved communication, responsibility and “ownership,” but few have the power or authority to do anything about it. Recently, the FDA has made repeated public statements to the effect that although the manufacturer is ultimately responsible for the drug, everyone in the supply chain has a responsibility to protect the drug from “adulteration,” adding, the manufacturer can delegate its responsibility but cannot relinquish its responsibility. The MHRA in the UK and Health Canada have followed the FDA’s lead in this effort. Heavy-handed regulatory oversight is what ultimately moves the process forward and has begun to move the responsibility for TTSD downstream.

Delivering drugs into a country, either through a tender or bulk shipping process to a central distribution location is a relatively routine process from the manufacturer or wholesale distributor. Once in-country however, the supply chain is rife with risk and breakdowns become more prevalent. The further a field the distribution, the higher the odds for exposure or temperature abuse.  Accidental freezing or exposure to high temperature for prolonged periods often comes as the result of geography, inadequate packaging, improper procedures, lack of necessary equipment, or improperly trained personnel. This why walking the system and characterizing the distribution process, is so important to understanding how to close or narrow the gaps.

Developing and implementing low-cost, elegant solutions to protect drugs from environmental hazards such as temperature and humidity, which require minimal human intervention or maintenance, is key to improving the delivery of drugs to developing and underserved areas of the world. Increasing the longevity, durability and availability of temperature controlled packaging and storage systems for things as basic and necessary as vaccines will not drive the medical, packaging or distribution industry. Their sights are targeted on the huge increase in high-value, high-profit biologics which continue to grow at double digit rates. The work of PATH, WHO, UNICEF, and others, is absolutely necessary although it lacks the sexiness and profit to offer more than cursory attention from most bio-pharma companies.

The greatest advances in insulated packaging systems over the next decade will not be in the area of improved insulation but in developing new ways to cool and maintain temperatures. Emerging technology like rapid evaporation is already changing the way we think about cooling.

 As the world of high-tech, bio-tech and personalized drug development continues to thrive in developed countries with well developed distribution models and infrastructures, low and middle-income countries can easily get lost in the shuffle. In order to keep pace, or at least not lag behind the rest of the developed world, improved systems, partnerships with industry, reinforced procedures, new and novel technologies and unique distribution models are opportunities waiting for those at the bottom of the healthcare pyramid.