By Jill Lauterborn, USAMRMC writerJuly 6, 2011
Bullets and bombs aren’t the only threats to Warfighters. Soldiers remain vulnerable to biological attack. The U.S. Army Medical Materiel Agency out of Fort Detrick, Md., arms troops with the best possible defense " the vaccine. USAMMA’s agile team of 14 ensure that vital immunogens are safely shipped to base medical facilities that treat nearly 1.4 million service members at 5,000 bases in the United States and its territories and another 700 bases worldwide.
In an age of one-click orders and express delivery, we sometimes forget the world remains a big place. Distance isn’t USAMMA’s only challenge. Global entities, weather patterns, even the timeless processes of Earth create new hurdles. Dotting the globe are 195 countries " their collective 49,000 airports and 600 ports all vulnerable to natural calamities, such as tsunamis, that disrupt supply chains. Political landscapes also shift, and often. Recent political upheavals in the Middle East and North Africa, for example, have threatened critical supplies of grain and medicine to countries troubled by violence.
Layers of complexity present enormous challenges for the shipping industry and others relying on contractual “guarantees.” On paper, USAMMA’s intricate relationship with agencies and manufacturers, vendors and shipping companies is a virtual wiring diagram. Its mission is further complicated by the delicate nature of vaccines. To make it all work requires expertise in scenario and contingency planning, an unyielding commitment to the Department of Defense’s standards, and fidelity to troop health, all the while operating with shrinking budgets and resources.
Born Out of Crisis
As tensions mounted over UN inspections in Iraq in the late 1990s, and rumors swirled over possible biological attacks against Soldiers, USAMMA, which oversees medical logistics and provides health service support to the Armed forces, assumed distribution of the anthrax vaccine, from manufacturer to medical facilities.
“We call it ‘from requirement to retirement,’ meaning we track the package all the way until it reaches its final destination, its customer,” explains Lt. Col. Todd Williams, USAMMA Pharmacist consultant and director of Support Operations.
Vaccine requests are submitted to a secure database. Once the Services approve a request, they send it to the USAMMA Distribution Operations Center for processing.
“We don’t have a big warehouse,” Williams explains. “When we stock the product, we partner with the Strategic National Stockpile. They do all the packing and the shipping for us. But we do all the tracking to make sure it gets to its location. That’s our unique specialty. We minimize losses for the DoD. When we see a hiccup, we’re there.”
USAMMA DOC, which provides supplies and services to the military worldwide, developed the cold-chain management system that follows a strict procedure for handling all vaccines. Sturdy shipping containers have 2 inches of polyurethane foam insulation. Gel packs surround the fiberboard boxes that hold vaccines, and each box is fitted with a temperature-monitoring device known as a TempTale. These multiple fail-safes are designed to keep the product in the critical range of 2⁰C"8⁰C (35⁰F to 46⁰F) for 72 hours, the time frame in which all shipments should reach their destination.
Andrew Brown, the Anthrax and Smallpox Project manager, tasked with distributing to all services, reflects on how far the DOC has come since its inception. “Today, we use carriers and have reliable resources like those monitors right in the package. Back then if we wanted to make sure it got there, we actually got on a plane with it. Can you imagine the manpower being wasted?”
Since 1998, USAMMA’s mission has expanded to include distribution of vaccines for smallpox and influenza, investigational new drugs and foreign military sales. Each year, the DOC distributes $40 million worth of vaccines, including 2.5 million doses for influenza, 1 million for anthrax and 350,000 for smallpox. The vaccination program’s goal is to erase the threat of these contagious and sometimes fatal diseases and ensure our Soldiers’ health and military readiness.
Train for Success
With so much at stake, training is a priority. The DOC is an integral part of the DoD’s Military Vaccine Agency, which operates an online information and training site, called MILVAX, for storing and handling vaccines. The DOC team provides onsite training and consultation and keeps medical facilities informed of all drug expiration dates and manufacturer recalls. They’re singularly responsible for educating all parties, from carriers to customers, about the policies and procedures to protect the integrity of vaccines.
To raise their profile and advance their mission, they reach out in a variety of ways: attending conferences, distributing literature, hosting briefings. Any staff turnover at the manufacturer, DOC, carrier or medical facility can wipe out gains in useful knowledge. So there’s always a new contact with a familiar question.
“We educate our customer every single day,” says Brown. “We have to make contact every day.”
In addition, the DOC actively scrutinizes data to identify and address gaps in training and prevent future vaccine losses.
“We track on the quality control side,” says Williams. “When we notice, for example, in Korea that they’re having some vaccine losses, that’s when we send a team over to provide additional cold-chain management training.”
If vaccines are indeed compromised, what follows is an intense scramble to replace that supply, explains Teresa Bess, Flu Program manager.
“We can’t just re-buy,” says Bess. “I have to start pulling from another location. A large loss can be very harmful, even to one’s career. Any installation that does not do what it needs to do is in violation of the Medical Command’s policies, guidance and regulations. Whatever vaccine is shot into a Soldier’s arm must be good, safe and effective.”
The Cold Truth
Overheated vaccines can sometimes be salvaged, but cold is a killer. TempTale, a temperature-monitoring device manufactured by Sensitech Inc., has been a great boon to the Army. It keeps a record of fluctuations and includes an alarm to alert a carrier that the package might be compromised.
“It monitors the temperature from the time it is packed until it gets to its destination,” says Brown. “It gives you a temperature range throughout that shipment " a high/low, an average and the time it was at those particular temps. Those monitoring devices have saved the DoD a huge amount of money by reducing loss.”
The TempTale is a DoD-specific requirement, one the docks started regularly using in 1999.
“When we called the FDA,” explains Williams, “we found out [manufacturers] have up to 48 hours to get the package to the site, and no temperature-monitoring device is required by the FDA. But we’re requiring it because we have a stricter standard. We want to know for sure that the product is reaching its destination in its appropriate temperature range.”
“A lot of companies test their product,” Brown adds. “If it ships or is received at the site within X amount of days, the priority is good. But if you go into different environments " that’s what DoD is looking at. You may be in a cold environment today, and you may be in a hotter environment the next day, and we want to make sure the product is staying within the temperature range.”
Racing the Clock
Temperature is only one aspect, though. Time is another, and choosing the right courier to expedite a shipment is key. Countries’ regulatory environments vary greatly, and so it’s important the courier has a clear understanding of customs processes and nuances to minimize delays.
“We use a variety of carriers,” says Brown. “If you’re not meeting our requirement, then your service is limited. If I used your service two years ago, that doesn’t mean I’m going to use it right away again. I have to do some test shipments to see if you still can deliver. Not with the actual product " I’m testing the route and how long it would take us to get there, and would it be anything that involved temperature fluctuations. We test the route before we release the actual product. We don’t want to waste it.”
Bess says the DOC regularly pursues cost-effective options. “We started this year using dedicated refrigeration trucks [for shipping the influenza vaccine], because you can hit a lot of locations, especially down here in the Joint Task Force region, instead of doing Fed Ex, Fed Ex, Fed Ex. Those locations get [packages] on pretty much the same day. And it did save the government money.”
As DoD’s requirements are stricter, the Defense Logistics Agency makes sure to hammer out every detail in the carrier’s contract.
“If you’re going to ship to DoD,” explains Williams, “we want you to use the cold-chain management principles. We want to make sure [our Soldiers] are protected.”
For those operating outside the safety of a thorough contract, Bess can only offer her sympathy. “I’ve had a couple of the [National Guard states] ask, ‘Ms. Bess, are my vaccines still good?’ Well, I don’t have the answer for them. You have to build [safeguards] into the contract.”
Ready for Anything
Put together an excellent process, validated packaging, a dependable courier and a clear route " the unexpected can still happen.
At no time was this more apparent than on March 11, 2011, when an 8.9-magnitude earthquake struck off the coast of northeastern Japan. The resulting 30-foot tsunami ravaged 1,300 miles of coastline, sweeping away port facilities and burying tarmacs and runways in silt. As events unfolded, shipping companies frantically adapted, accounting for cargo, seeking alternate routes.
“A lot of carriers were trying to avoid Japan,” Brown says. “If I have to go through Manila, then it’s a different process, customs paperwork. And so that is obviously a challenge.”
Certainly such a force majeure would limit one’s liabilities, but USAMMA’s sensible and timely reaction in crisis salvaged irreplaceable vaccines. It boils down to having contingency plans in place. The DOC uses several carriers to ship vaccines to the destination. If one carrier is unable to deliver because of a route change, the DOC quickly secures an alternate that can meet the delivery deadline while adhering to cold-chain management procedures.
An Eye on the Ball
Delivering critical vaccines worldwide on time and intact takes a team willing to deal with the myriad challenges. Whether USAMMA’s couriers appreciate it or not, an extra set of eyes is always tracking those vital shipments.
“When we see that package get hung up, we’re calling people,” Williams says.
“We are constantly on the phone with the carrier or our customer,” Brown agrees. “If there’s additional paperwork, we either fax it, e-mail it or figure out the quickest way to get there. Once that package lands, we know, and if the recipient doesn’t call us right away, we’re on that phone. They say, ‘Oh, yeah, I just got it.’ Yes, but you need to call to confirm. When our package is not moving, we contact our carriers. We ask why. They say, ‘It’s on the plane.’ But your tracking system is saying it’s still here " you need to update your tracking system.”
Success requires dogged determination from a dedicated team, 24/7.
“We have a leash,” says Brown, holding up a Blackberry. “When we’re sleeping, other people are available to receive calls if there are any problems or questions. If we know a package’s estimated arrival is midnight our time, then yes, we still track it. And if we don’t hear from them, we make the call. We’re a small operation, but we produce volume. Some days are more taxing than others. There’s never a dull moment.”
There are countless long nights resolving logistical issues, particularly during 2009’s H1N1 scare. It comes with the territory, says Bess. “You know what gets me through? Loving my military. Each and every one of them deserves the best I can provide. They have such dedication to mission and stand for freedom for all of us. We owe so much to our military for all we have as a country.”