Drug Expiration Dates Are Often Meaningless

And we waste billions of dollars thinking otherwise.

by Jesse Hicks
Jul 19 2017, 10:17pm

Every year, hospitals dispose of hundreds of millions of dollars worth of expired drugs. The same thing happens in pharmacies and in medicine cabinets across the country: The United States likely tosses away billions in prescription medication, thanks to arbitrarily set expiration dates.

Many of those—including life-savers such as naloxone and EpiPens—are still effective, but legally can't be dispensed beyond their expiration date and must be destroyed. Moreover, the Food and Drug Administration, which helps set these dates, has long known that many drugs remain effective and safe well after they've supposedly expired. The federal government, meanwhile, has saved billions ignoring those dates, and yet hospitals and pharmacies around the country are forced to toss their expired drugs.

That's all according to a new report from investigative reporting group ProPublica, which opens with the discovery of a cache of pills 30 to 40 years past their expiration dates in the back closet of a pharmacy. Researchers tested 14 compounds—including antihistamines, pain relievers, and stimulants—and even after decades in their original, sealed containers, 12 of the compounds were still as potent as when they were manufactured. Some were close to 100 percent of their labeled concentrations.

The scientists knew that drugs don't suddenly become ineffective (or worse, toxic) the day after their expiration date. The dates on labels actually indicate how long the FDA and pharmaceutical companies guarantee effectiveness, which is typically two or three years after manufacture. As you may have already guessed, there's no incentive for drugmakers to test just how long their products could remain effective. So they don't.

The federal government, though, does do such testing—and has been for more than 30 years. That's because it has massive stockpiles of medication, vaccines, and antidotes stored around the country in case of emergency. It's a collection worth tens of billions of dollars, but in the absence of major disease outbreaks, those drugs don't get used before they hit their expiration date.

Rather than spend more money to continually replenish their stash, the government agencies that manage them—including the military, the Centers for Disease Control and Prevention, and the Department of Veterans Affairs—have looked into extending expiration dates. The aptly named Shelf Life Extension Program, for example, created by the FDA and Defense Department more than three decades ago, found that the actual shelf life of many drugs is well beyond the expiration dates.

Marc Young, a pharmacist who helped run that program, told ProPublica not having to replace expired medication saves the government $600 to $800 million each year. The Department of Defense, which maintains a drug stockpile worth about $13.6 billion, told ProPublica that it spent $3.1 million on its extension program in 2016, an investment which saved $2.1 billion in drug replacement costs. "We didn't have any idea that some of the products would be so damn stable—so robustly stable beyond the shelf life," Ajaz Hussain, a scientist who helped oversee the program, told ProPublica.

So the government has long saved billions by ignoring expiration dates in favor of using science to establish how long drugs can actually remain effective. But when the researchers who tested those long-forgotten pharmacy drugs published their results in 2012—scientifically demonstrating a much longer shelf-life than anyone expected—some people accused them of irresponsibly suggesting that patients should take expired drugs. Interest in their study faded, and nothing changed.

That leaves us with a status quo in which life-saving drugs are thrown away simply because of a date on a label. ProPublica describes pharmacist David Berkowitz filling bins with expired medications, including EpiPens, which automatically inject epinephrine to quell severe allergic reactions. The devices (controversially) cost about $300 each, but because they're used only in emergencies, they typically expire. Berkowitz has a pile of 50 of them—almost $15,000 worth of emergency medicine wasted. "I question the expiration dates on most of these drugs," Berkowitz told ProPublica. One pharmacist told reporters that he sometimes takes home expired medications for his family to use, rather than throwing them out.

In May, the same scientists who tested the cache old drugs published a study on EpiPens, showing they lasted longer than their labels indicate. So why doesn't the FDA expand the stockpile-testing programs that government agencies already use to cover hospitals and pharmacies, which likewise store drugs under carefully controlled conditions? It would save people money on prescription copays and the cost of insurance, keep more medication in circulation, and bring scientific rigor to a process that right now is basically arbitrary.

ProPublica asked just that question. The response: "The Agency does not have a position on the concept you have proposed." For now, the status quo prevails, though the need for change is obvious. "The FDA will have to take the lead for a solution to emerge," Hussain, the former FDA scientist, told ProPublica. "We are throwing away products that are certainly stable, and we need to do something about it."

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