Long read: Are drug expiration dates meaningless?

If you are like us, this is a question which you have been asking yourself for many years but were too lazy to do the research necessary to answer the question. Thanks to Keren Landman, MD, your quest for getting a satisfactory answer to the question of how seriously to take drug expiry dates is now over. She says, “The US Food and Drug Administration only began requiring drug manufacturers to put an expiration date on medications in 1979. However, they didn’t tell companies how to come up with those dates. Most companies didn’t opt to do the expensive work of methodically testing each drug during development to determine the exact age at which it began degrading. Instead, most simply chose dates a few years out, tested the drug’s potency at that time, and if it was still as good as new, called that the expiration date.

That is to say, drug expiration dates aren’t “bad after” dates as much as they are “good before” dates. For most drugs, these dates are set to about three years after the day they’re produced, says Lee Cantrell, a pharmacist and toxicologist who also directs operations at the San Diego division of the California Poison Control System.

However, many drugs retain much of their potency for a lot longer than three years. In 2012, Cantrell and several of his colleagues tested a range of drugs (including acetaminophen, the sedative phenobarbital, and the opioid hydrocodone) that were decades past their expiration dates, and found that 86 percent of them still had the intended concentrations of their active ingredients. A few years later, a group of German researchers conducted a similar study with similar results.”

Now, as many of you would have already clocked, there are parties involved in all of this who don’t want anyone to figure out how long after the official expiry date, the efficacy of the drug is actually retained: “There’s an obvious disincentive for manufacturers here, Cantrell says: Proving that certain products have much longer shelf lives than we assume would mean less frequent re-upping, which would decrease sales. Some manufacturers may actually have done studies proving their products last well beyond their expiration dates — but “there’s no way they’d ever release that data — it’s just not in their interest,” Cantrell says.”

The self-serving behaviour of the pharma companies imposes a cost on society So In USA, certain parts of the administration decided to do something about this. Dr Landman says: “Replacing drugs that are still effective is wasteful and expensive. In an effort to make better use of their drug supplies, federal agencies that stockpile drugs — like the military or the Department of Veterans Affairs — asked the FDA to extend the official shelf life of several drugs in the 1980s. The agency developed the Shelf-Life Extension Program to do exactly that by batch-testing key medications on the brink of expiring.

Still, these extensions happen only on a case-by-case basis — and only for pharmacies run by government institutions. Although expiration dates don’t accurately represent the true lifetime of a drug, the system we have right now doesn’t account for that.”

Leaving aside the vested interests of the pharma companies, there is a deeper issue which complicates the matter – some drugs actually becoming stronger AFTER the expiry date whereas others don’t: “For starters, pharmaceuticals don’t typically turn into poison as they age. “I’m not aware of any medications that become toxic once they pass their expiration date,” Cantrell says. That means you typically don’t have to worry that an expired drug will make you sick. However, because some drugs do lose potency over time, expired drugs may do some harm by not working the way you expect them to.

With time, there may also be changes to the integrity of some drugs’ inactive ingredients. These are the medication additives that get drugs’ active ingredients where they need to go or make them palatable for the consumer. For example, a skin cream used for eczema might separate or change in texture over time, or a suppository containing fever medicine might melt. Conversely, liquid formulations can slowly condense as the water and alcohols in them evaporate. This means a shot from that older bottle of NyQuil could theoretically be stronger than it’s supposed to be.”

All of that being said, Dr Landman says that it is NOT very difficult for the pharma companies to put more accurate expiry dates on drug labels so that society can move towards a better equilibrium (as opposed to the current situation where all of us throw away useful drugs just because they have passed their expiry date).

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