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.