Disease Prevention

Forging the Links of Cold Chain Medication

When Direct Relief receives a donation of insulin, it is stored in the organization’s 2,800-square-foot cold room, which stays between between 36 and 41 degrees Fahrenheit. The room is stacked floor to ceiling with temperature-sensitive medications, like insulin and vaccines, and where that medication is packed into special cold shipping containers that keep temperature consistent until the insulin arrives at the health center, clinic or hospital able to store it and administer to patients. (Lara Cooper/Direct Relief)
When Direct Relief receives a donation of insulin, it is stored in the organization’s 2,800-square-foot cold room, which stays between between 36 and 41 degrees Fahrenheit. The room is stacked floor to ceiling with temperature-sensitive medications, like insulin and vaccines, and where that medication is packed into special cold shipping containers that keep temperature consistent until the insulin arrives at the health center, clinic or hospital able to store it and administer to patients. (Lara Cooper/Direct Relief)

It may be 80 degrees and sunny outside Direct Relief’s Santa Barbara warehouse, but in a house-sized box inside the warehouse, it feels like a winter day.

Cold wind blasts down from the industrial fans overhead. It cuts through the parkas workers don before entering Direct Relief’s cold chain room, making it feel far colder than the 4-degree Celsius reading on the temperature gauge. Inside the room are racks of shelves rising to the ceiling, filled with cartons of insulin, vaccines and some of the world’s newest and most advanced medicines.

In late June 2018, Direct Relief opened its new headquarters and warehouse, and with it the new cold chain facility. The refrigerated room, funded by BD, combines a suburban home-sized 2,800 square feet of floor space with a three-story ceiling.

The cold chain room has been a portal to a new world of capability for Direct Relief, greatly expanding the organization’s ability to deliver medicines that require constant refrigeration. This, in turn, has already given tens of thousands of people around the world access to lifesaving insulin for controlling diabetes, vaccines for fighting a myriad of diseases, and advanced treatments for rare genetic disorders.

Insulin provided by Eli Lilly is shipped from Direct Relief's warehouse on August 1, 2018. The insulin was bound for the Santa Barbara County Public Health Department, which receives medicines and supplies from Direct Relief on a regular basis. (Lara Cooper/Direct Relief)
Insulin provided by Eli Lilly is shipped from Direct Relief’s warehouse on August 1, 2018. The insulin was bound for the Santa Barbara County Public Health Department, which receives medicines and supplies from Direct Relief on a regular basis. (Lara Cooper/Direct Relief)

The “chain” in cold chain is the supply chain delivering a medicine from manufacturer to patient, during which the refrigerated product must be maintained between 2-8 degrees Celsius.

Direct Relief’s giant refrigerator is only one link along the cold chain. Each cold chain package contains a temperature data log that maintains a record of temperatures throughout the entire delivery process. The drugs are often shipped to places that take multiple flights and long trips by road and are shipped in packaging that maintains the temperature range for up to 120 hours.

The cold chain capability of Direct Relief’s new warehouse enabled the organization to double the amount of cold chain medicine it shipped in fiscal year 2019 compared to fiscal year 2018.

Prior to July 2018, Direct Relief was able to distribute a smaller amount of cold chain medicines that were stored in pharmaceutical-grade refrigerators in its warehouse or through drop shipments sent directly from the manufacturer to the end recipient. In the 2019 fiscal year that ended June 30, Direct Relief delivered 1,462 cold chain shipments with a wholesale value of $203 million, doubling the 692 shipments delivered in 2018 at a value of $103 million.

Over the past year, Direct Relief has shipped insulin to countries including Eritrea, Tajikistan, and Pakistan; shipped blood-clotting hemophilia treatments to Puerto Rico, El Salvador, and Jamaica; and shipped cancer treatment drugs to Malawi, Belarus, and Syria. Countries receiving the most shipments include the United States, South Africa, Uganda, Zimbabwe, Haiti, Honduras, Dominican Republic and Malawi.

“There’s a broad-based need for this capacity across many different health issues, from vaccination campaigns to diabetes and cancer therapies, in places where people lack access to resources,” said Thomas Tighe, CEO of Direct Relief. “Expanded cold chain capacity has let us reach more people in need of medicine that they lack any other way of obtaining.”

Direct Relief’s Andrew MacCalla and Ruben Bras of the Puerto Rico Primary Care Association load a cold shipping container full insulin donated by Eli Lilly into a van for transport to a San Juan primary care clinic. (Lara Cooper/Direct Relief)
Direct Relief’s Andrew MacCalla and Ruben Bras of the Puerto Rico Primary Care Association load a cold shipping container full insulin donated by Eli Lilly into a van for transport to a San Juan primary care clinic after Hurricane Maria. (Lara Cooper/Direct Relief)

“It certainly opened up new opportunities to help more people,” says Dawn Long, Direct Relief’s chief operating officer. “A lot of these cold chain medicines are lifesaving.”

Trends in drug development have made cold chain increasingly important. Pharmaceutical companies have shifted their efforts away from chemicals-based small molecules to biologics and other large-molecule drugs, often created from living human cells. Most of these advanced drugs need to be refrigerated.

Some pharmaceutical makers have charitable programs that allow people who otherwise couldn’t afford a medication to apply for donated drugs. But many of these people are living in developing parts of the world that lack rapid, efficient delivery networks.

The cold chain facility has helped Direct Relief scale up its donations of insulin working with the Life for a Child program. Insulin should be kept between 2-8 degrees Celsius in order to last more than 28 days.

In fiscal year 2019, Direct Relief oversaw the end-to-end supply chain for over 275,000 vials of insulin donated by Eli Lilly and Company for the benefit of over 16,000 children with Type 1 diabetes across 30 countries including Mali, Pakistan and Bolivia.

The cold chain capacity has also enabled a growing Direct Relief rare disease program. Pharma companies often invest hundreds of millions of dollars to develop a single drug for a rare disease, which is then sold for hundreds of thousands of dollars per course of treatment. These manufacturers sometimes have charity programs in which they provide treatment for free to a limited number of people in developing countries who would otherwise have no chance of being able to afford it.

Direct Relief in fiscal year 2019 delivered $37 million in drugs donated by Takeda to treat rare genetic diseases called lysosomal storage disorders. The added cold chain capability also enabled Direct Relief to begin working with Amgen on its International Rx Access program, delivering $79 million in medications in fiscal 2019, the first year of the program.

A shipment of critical insulin for the Syrian American Medical Society is staged for pickup in temperature-controlled packaging at Direct Relief’s warehouse in California on April 17, 2018. (Martin Calderon/Direct Relief)
A shipment of critical insulin for the Syrian American Medical Society is staged for pickup in temperature-controlled packaging at Direct Relief’s warehouse in California on April 17, 2018. (Martin Calderon/Direct Relief)

Direct Relief uses specialized packaging to maintain a constant temperature for between 48 and 120 hours. They’re packed either with water-based gel-packs or with more advanced phase-change materials (PCMs). Direct Relief uses both summer packs and winter packs designed for different seasonal temperature ranges.

Direct Relief’s inventory management system lets it monitor the progress of every package toward its destination. Direct Relief is now working with its shipping partners on “lane assessments” evaluating potential routes to determine the most reliable ones—those most likely to allow the packages to get to their destination before the coolant stops working.

The cold chain delivery capacity goes beyond Direct Relief’s ability to manage shipments through its own refrigeration room. It is also able to better manage drop shipments—deliveries from manufacturers or other warehouse locations direct to recipients. As part of its program with Amgen, Direct Relief has managed the shipping of over 100,000 units of an essential medicine to fight life-threatening infections in underserved cancer patients undergoing chemotherapy in 15 countries.

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