Magazine Article | June 9, 2011

Cold Chain Beyond The Industrial World

Source: Life Science Leader

By Fred Olds, Life Science Leader magazine

The genius that led to the discovery of vaccines also led to innovations that allowed them to be safely transported long distances. Today vaccines are transported in time-and-temperature-controlled conditions to the remotest reaches of the developed world, and an international sense of responsibility for the welfare of children has led to ambitious vaccination goals. Accomplishing these goals will require innovations in the ways vaccines are shipped to various climates across the globe.

In 2000, the UN established eight millennium development goals (MDGs) to fight, among other things, poverty, illness, and illiteracy. The fourth goal is to reduce the under-five mortality rate by two-thirds between 1990 and 2015. A major effort to achieve this goal relies on vaccination programs and getting vaccines to underdeveloped countries. While the cold chain in the West is extremely complex and requires great care, it is reliable.

The Logistics Of Delivery
Dmitri Davydov, contracts specialist, UNICEF supply division, says these vaccination initiatives are challenging, but they work. Davydov explains that transportation begins in the origin country. For instance, a U.S. company manufactures and packages the vaccines to WHO/UNICEF specifications and delivers them to an international airport in the United States. UNICEF takes responsibility there and has the vaccines shipped to a major airport in the assisted country. In ideal situations, UNICEF turns the vaccines over to the country’s Ministry of Health. The country accepts the drugs, returns them to cold chain in medical stores, and distributes them as needed in the national vaccination program.

Davydov says it’s UNICEF’s job to support government efforts and monitor vaccination programs. Frequently, UNICEF has to adapt to situations on the ground, and sometimes they get involved in actual distribution. “In extreme cases where there are emergencies, there is no strong central government, or civil war interrupts vaccination, UNICEF may run the program in support of the government. UNICEF also often handles vaccine distribution during national immunization campaigns,” he says. “We go further where common sense and children’s interests dictate.”

Since shipments to these locations have a higher risk for the unforeseen, caution becomes the rule. Oumer Salim, manager supply chain, global specialty & cold chain for Pfizer, says, “For shipments to less-developed nations where Pfizer does not have established logistics lanes, products are shipped in the most robust passive package systems. These systems are qualified to maintain tight internal temperature control for 120 hours while external temps may be extremes of either heat or cold.”

For WHO-affiliated programs, Salim collaborates closely with WHO to utilize the appropriate prequalified systems specific for each shipment. In an effort to expedite shipments, reduce confusion, and provide uniformity, WHO “prequalifies” everything involved with the shipment of vaccines through testing. Pfizer procures prequalified packaging from vendors specializing in cold chain and uses preferred freight forwarders familiar with WHO criteria to transport its medications. Together they develop detailed SOPs for shipments that meet not only WHO requirements but also their own internal standards. Salim says, “Operations are monitored, and any deviation is reported and investigated.”

Increasingly, logistics service providers are being asked to transport cold-chain shipments to less developed areas, says Kevin McPherson, global marketing director, product management, UPS healthcare logistics. “This requires much more complex planning. There are more handoffs and a longer time in transit. It’s essential to know the requirements in advance and plan around them.” McPherson says, “When we work with clients, we need to know product specifications, in-transit expectations on delivery times, and information about any partnerships the company has in the region, for example.” They should also expect the provider to plan sophisticated monitoring processes to put visibility tools around the shipment and work on risk mitigation strategies.

Added to the mix is the requirement to keep up with regulations and laws. WHO provides guidelines and recommendations on the transportation and storage of vaccines and pharmaceuticals, but governments and many other entities promulgate regulations, interpretations, and guidelines, as well. It’s important to work with a provider who has in-country expertise. There are issues of interpretation, not only of language, but of the regulations themselves. For example, in 2008 the U.S. Department of Transportation imposed a ban on certain lithium batteries based on its interpretation of hazardous material regulations. This ban in turn restricted the use of some battery- operated monitors used to track cold chain for medications in transit.

McPherson says, “This underlines the need to look for providers that have dedicated compliance and regulatory affairs departments that can navigate regulations country to country.” Salim agrees, “It’s one of the biggest challenges we face.” He suggests participation in industry forums and following what other companies in the industry are doing. He says you can also rely on colleagues in the area to help you understand customs and acquire legal guidance.

Finding The Child
Usually vaccines are pushed from the central storage facility and shipped to the practitioners at field clinics where the vaccines are stored and administered on a routine basis. The cold chain becomes very difficult at this point. Electricity may be unreliable. Additionally, there are times when vaccines have to be transported by pack animal, on foot, by boat, or by truck to locations distant from the clinic. When it became evident there were gaps in vaccination coverage from field clinics alone, WHO/UNICEF initiated the RED program (Reach Every District). Among the actions recommended in RED were supplemental immunization activities (SIAs), which included forays into underserved areas to educate and treat populations not visiting the clinic on their own.

Technology Where Silicon Meets Sand
Bujumbura, Burundi, is one of hundreds of nodes in the developing world where modern cold chain mixes inconsistently with limited resources. Recent advances in “green,” passive pallet, or reusable shippers might actually increase logistical difficulty for these locations. UNICEF and assisted countries have little capability to return shippers, and one can’t be sure if a forklift will be available to offload a pallet-sized shipment.

But, hi-tech has contributed dramatic improvements to the rural cold chain such as the GPS and online maps mentioned earlier. The VVM (vaccine vial monitor) is technology discovered and championed by PATH (Program for Appropriate Technology in Health). It is a small sticker that adheres to a vaccine vial to indicate viability of a vaccine. As the vial is exposed to heat, the VVM darkens over time in response to the cumulative amount of heat exposure. Healthcare workers can easily see whether a vial is active or should be discarded. During its adoption over the past 10 years, it has saved thousands of doses from being discarded and prevented inoculation with inactive vaccines. Ironically, says Davydov, freezing was a greater danger than heat in the past. In hot weather, practitioners would throw ice on the vaccines fearing they’d lose potency in the heat. It would often freeze and ruin the medicine. The VVM gives reassurance of viability and reduces the temptation to ice vials inappropriately. Salim says VVMs have been designed to respond to different heat tolerances. So, it’s important to select a VVM with a heat range tolerance appropriate for a specific vaccine.

Solar power is another example. In areas where the national power grid may be inconsistent, clinics often rely on backup generators to run refrigerators. Generators require fuel and maintenance, so they too can be out of service. Using solar panels, clinics can reliably generate enough DC electricity to power small active-cooling refrigerators. In locations where vaccines have to be transported long distances and small passive coolers are inadequate, solar-powered refrigerators have been mounted on vehicles and pack animals. The Camel Fridge used in Saharan Africa is an iconic image of the union of technologies from very different eras.

Issues And Opportunities
Anyone living on a mountaintop in Tibet knows something about supply chain. We in the West suspect we could improve their logistics with our technology, but it would be presumptuous to donate an SUV to deliver vaccines, when the Tibetan, if asked, would choose a lightweight alloy frame and rip-stop adjustable packs fitted for a yak as the better solution.

Perhaps there is additional value those in the cold chain could offer to relief organizations operating in the Third World. The best and brightest minds are drawn to pharma and logistics to innovate. Industry has expertise in technology, collaboration, systems, medications, and packaging. It’s conceivable that collaboration between industry and various individuals in the relief organizations might result in relatively inexpensive solutions and technological adaptations that would revolutionize the cold chain in developing nations. It might just take a conversation and a mile in someone else’s sandals in the savanna.