Program Extends Drug Shelf-Life

By Jim Garamone

American Forces Press Service

WASHINGTON, March 29, 2000  Military health officials have saved American taxpayers millions through a testing program that extends the shelf life of drugs.

All services participate in shelf life extension program, said DoD officials. The drugs are mostly those that are militarily significant items, said Army Maj. Marc Caouette, a pharmacy consultant assigned at the U.S. Army Medical Materiel Agency at Fort Detrick, Md.

Pentagon spokesman Ken Bacon said the testing applies only to stockpiles of drugs and not all of the $1.2 billion in prescription and over-the-counter drugs DoD buys each year. Bacon said March 28 that the war reserve stock of drugs encompasses about $87 million in drugs.

The program grew out of a 1985 Air Force initiative. The Air Force went to the Food and Drug Administration and asked if the FDA could check the expiration date of some of the drugs in the stockpile, Bacon said. The Air Force wanted “… to find out if the drugs were safe and potent beyond the expiration date set by the manufacturers.

“The FDA did this and found basically that the expiration dates tended to be very conservative, and as a result, many of these drugs could have a much longer shelf life than the manufacturers said.”

Caouette said an example of one of the drugs with an extended shelf life is ciprofloxacin. “It’s a broad spectrum antibiotic that’s used to treat many different bacterial infections, and also happens to be a medicine that can be used to combat biological warfare.”

The military has large quantities of this drug. So much so, in fact, that the manufacturer will not agree to take back the drug for credit when it expires, as they do for civilian users. “So rather than wasting it, we’ve put that product into our shelf-life extension program and have the FDA conduct the testing to see how long we can use that material past the labeled expiration date,” he said.

In the case of ciprofloxacin, the original expiration date was 1993. With the testing the shelf life has been extended to 2001 and further testing may extend it further.

Other drugs include the atropine automatic injectors DoD developed to combat chemical weapons pralidoxime chloride, diazepam (also called valium) to combat seizures brought on by nerve agents, and chloroquine anti-malaria tablets.

The products don’t get the full amount of shelf life following testing, Caouette said. The FDA measures the potency of the drugs and assigns another expiration date.

The FDA does all the testing. “They have all the laboratory facilities and they have all the product release specifications because they were the ones who approved the product in the first place,” Caouette said. “The drugs are tested to the same specifications as new medications just coming off the line.”

In fiscal 1997, DoD avoided spending $23 million to replace these drugs. “The testing cost $172,000,” Caouette said. “This means $135 saved for every dollar spent.”

In fiscal 1998, DoD saved $40 million with $260,000 spent on testing for a ratio of about 154 to 1. The fiscal 1999 figures to date indicate $33 million saved on $240,000 spent on testing. “Not all the tests are back from the fiscal 1999 tests, so we expect the 137 to 1 ratio to be even better,” Caouette said.

He stressed the military stores the drugs under optimal conditions. “Either a controlled room temperature warehouse where we monitor conditions. If the drugs have to be refrigerated we have purchased the appropriate refrigeration devices.”

Caouette said service members should not believe drugs in their medicine cabinets that are past expiration dates are safe and effective. “Probably the worst place in the world to store drugs is in your bathroom medicine cabinet,” Caouette said. “The worst possible place you can keep any medications is in a wet, hot environment. It’s the worst area to maintain stability. A cool, dry place is best to store drugs.”