Are drug expiration dates meaningless?

It’s late at night, and someone in your house has a headache, a stuffy nose, or – oh no, was that a crying sound? You shoot through the home medicine mix, silently pumping your fist in the air as a bottle of Tylenol or Pepto-Bismol finds its way into your hand.

Only then do you see the expiration date: It was last month, last year, ten years ago. You realize that you don’t know what that really means – whether the drug you’re holding is dangerous or ineffective, and whether you could be causing more harm by using it or not.

For many, medication expiration dates are a source of fear and uncertainty. Whether it’s a fever reducer or a serious heart medication, knowing how to assess the risk of taking it – or not taking it – can save you a lot of worry. Here’s what you need to know about how medicines age.

Expiration dates are somewhat unique

The US Food and Drug Administration only began requiring drug manufacturers to set expiration dates for drugs in 1979. However, they did not tell companies how to come up with those dates. Many companies did not choose to do the expensive work of testing each drug during development to determine when it began to degrade. Instead, many chose only a few days, the strength of the drug was tested at that time, and if it was still fresh, it was called the expiration date.

That is, drug expiration days are not “bad after” days as much as “good before” days. For most drugs, these dates are set about three years after the date of manufacture,​​​​​​​says Lee Cantrell, a pharmacist and toxicologist who also runs operations in the San Diego of the California Poison Control System.

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

One of the German researchers, Ulrike Holzgrabe, a medicinal chemist at the University of Würzburg, told me these findings suggest that drug companies should choose expiration dates more aggressively. He said: “After granting drug approval, companies should store drugs for another 10 years” and check them annually for stability.

There’s a clear criticism for manufacturers here, Cantrell says: Proving that some products have a longer shelf life than we think can mean frequent declines, which can reduce sales. Some manufacturers may have done research proving their products last past their expiration dates — but “there’s no way they’re going to release that data — it’s not in their best interest,” Cantrell says.

Replacing drugs that are already working is wasteful and expensive. In an effort to make better use of their drug supply, government agencies that collect drugs – such as the military or the Department of Veterans Affairs – asked the FDA to extend the shelf life of several drugs in the 1980s. The agency has established a Shelf-Life Extension Program to do exactly that by conducting a review of essential drugs that are on the brink of expiration.

However, these extensions only happen on a case-by-case basis – and for pharmacies run by government agencies. Although expiration dates do not accurately represent the actual life of a drug, the system we currently have does not account for that.

Drugs change with age, but not in the way you might fear

Part of the problem with medication expiration dates is that it is difficult to tell visually when most drugs have passed their expiration date. “A drug is not yogurt or a piece of meat or a strawberry,” Holzgrabe says. However experts have an understanding of the kinds of subtle changes that drugs can have over time.

At first, medicine does not become toxic as it ages. “I don’t know of any drugs that become toxic once they pass their expiration date,” Cantrell says. That means you don’t have to worry about an expired drug making you sick. However, because some drugs lose their effectiveness over time, expired drugs can cause harm by not working the way you expected them to.

Over time, there may also be changes in the integrity of the inactive ingredients of some drugs. These are pharmaceutical supplements that get the active ingredients of the drug where they need to go or make them more palatable to the consumer. For example, a skin cream used for eczema may separate or change shape over time, or a cream containing flu medicine may dissolve. Liquid compounds, on the other hand, can slowly condense as the water and alcohol in them evaporate. This means that the shot from an old bottle of NyQuil may be stronger than it should be.

Sometimes, time can make the medicine system obsolete, which makes you unable to find the real medicine in it. It’s the same idea that makes an old can of shampoo unusable even though there’s plenty of product left inside: Medicines that rely on propellants – such as sprays that control itching or albuterol rescue inhalers that people use to control asthma symptoms – often change. they are useless when their containers are too old.

It’s not just age that changes the potency of our medicines: The way they are stored can also have an impact. Exposure to sunlight, heat, and moisture all degrade drugs rapidly. This exposure can also facilitate the growth of pathogens, even out-of-date medications. Although this risk has more to do with unsafe drug storage than the age of the drug, it is important to note. That’s especially true for medications that are meant to be sterile, like eye drops, since contamination can lead to permanent eye damage in people who use these products.

How to manage family medicine to reduce anxiety

To prevent drugs from losing their potency prematurely and to reduce the chance that they will be contaminated by germs, Holzgrabe recommends keeping them in the bedroom — not in the bathroom or in the bathroom. the kitchen, where they are likely to come into contact with heat and moisture.

The safest way is to keep only a limited supply of drugs in your home – especially when it comes to critical, life-saving drugs like antibiotics, blood thinners, EpiPens, inhalers asthma relief, insulin, etc. The FDA regularly urges consumers to check what they have and throw away expired drugs. The center also provides recommendations on how to safely dispose of different types of drugs.

That said, if you find yourself in an emergency situation where you have run out of life-saving medication and can’t get a new supply immediately, use the medication you have – as long as it’s not too late gets it. a patient in emergency care. Cantrell says: “If someone called me and said, ‘This is all I have and I’m having trouble breathing and breathing,’ I would say, ‘Use it,'” Cantrell says. Cantrell says.

The truth is that experts say that they often use expired medicines in uncertain situations at home – if they have a child with a cold, for example. However, it is not something they would recommend to others; there just needs to be a rigorous clinical trial before they can give that kind of advice broadly.

Although drugs may last longer than their packaging states, it should not be up to consumers to guess which ones are still working. Instead, manufacturers should study each newly approved drug to determine how it expires by keeping track of its quantity and testing its stability every year, he says. Holzgrabe. Strong regulation of the pharmaceutical industry will help, he says: “The law must be changed so that we don’t throw away so many drugs that are still good.”