Is it that medicines don’t expire?

Is this “use by” date or “date of expiry” of any consequence, or is it like that package which proclaims a million-year old Himalayan salt, allegedly dug out from the depths, and is then sold with a six-moth expiry date on the bottle? Do medicines actually lose their potency after that special “expiry date”?

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By Chanakya

Do medicines really have an expiry date, or are we being taken for a ride by pharmaceutical companies? Is this “use by” date or “date of expiry” of any consequence, or is it like that package which proclaims a million-year old Himalayan salt, allegedly dug out from the depths, and is then sold with a six-moth expiry date on the bottle? Do medicines actually lose their potency after that special “expiry date”?

One Dr Mohsin Jaffer of Florida, USA has been quoted in an article written by Richard Altschuler recently, but that was not the only article on the issue. Several other experts and medical practitioners have written on the issue on several occasions and blamed the pharma companies of profiteering by scaring the common man.

Referring to the US, the doctors say that before 1979 no expiry date was ever mentioned on medicines. It was in 1979 that this practice started in USA.

NOTE OF CAUTION:
This article is based on conjecture and opinion of certain person(s), organisations. Views on News offers this as an alternative opinion, and not as an expert comment, so does not take responsibility of its contents. While deciding on your own medicines, please take the advice of a medical doctor/expert.

–      Editor

So, do medicines really expire?

The writer gives an example: “If a bottle of Tylenol, (paracetamol) for example, says something like ‘Do not use after June 1998,’ and it is August 2002. Should you take the Tylenol? Should you discard it? Can you get hurt if you take it? Will it simply have lost its potency and do you no good?” In India the brand name for paracetamol would be Crocin or Calpol and some others.

This is an over the counter medicine in India and in many other countries. It is also cheap in India, so not many people really care. But what happens to very expensive antibiotic tablets and such other medication? Do they too lose their potency, or do they become poison after their expiry date?

If not, then the argument that drug manufacturers are being dishonest with us when they put an expiration date on their medications to get us to buy new medications when the old ones that purportedly have expired are still perfectly good, holds water.

Let us first see what the article in question says about what the author has found. He writes that he “immediately scoured the medical databases and general literature for the answer to my question about drug expiration labelling. And voila, no sooner than I could say Screwed again by the pharmaceutical industry, I had my answer.”

He places his findings:

The findings

“FIRST, the Expiration date, required by law in the United States, beginning in 1979, specifies only the date the manufacturer guarantees the full potency and safety of the drug – it does not mean how long the drug is actually “good” or safe to use.

“SECOND, medical authorities uniformly say it is safe to take drugs past their expiration date – no matter how “expired” the drugs purportedly are…

“Studies show that expired drugs may lose some of their potency over time… Even 10 years after the ‘expiration date,’ most drugs have a good deal of their original potency.”

The author narrates an important anecdote about a big study done by the US military some years back. He quotes from an article in The Wall Street Journal of March 29, 2000 (reported by Laurie P. Cohen) which said: “The military was sitting on a $1 billion stockpile of drugs and facing the daunting process of destroying and replacing its supply every 2 to 3 years. So it began a testing programme to see if it could extend the life of its inventory.

“The testing, conducted by the US Food and Drug Administration (FDA), ultimately covered more than 100 drugs, prescription and over-the-counter. The results showed, about 90% of them were safe and effective “even 15 years past their expiration date…”

That was a deal-breaker of sorts. He says that “In the light of these results, a former director of the testing programme, Francis Flaherty, said he concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer period.”

Frankly, this was big.

An article published by Harvard Medical School on August 29, 2020, titled: ‘Drug Expiration Dates — Do They Mean anything?’, also reiterates this stand. It says: “It turns out that the expiration date on a drug does stand for something, but probably not what you think it does. Since a law was passed in 1979, drug manufacturers are required to stamp an expiration date on their products. This is the date at which the manufacturer can still guarantee the full potency and safety of the drug.

“Most of what is known about drug expiration dates comes from a study conducted by the Food and Drug Administration at the request of the military. With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.”

The possible exceptions

This is heartening. Experts have named just a few exceptions. The article says: “A rare exception to this may be tetracycline, but the report on this is controversial among researchers. It’s true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date. Excluding nitro-glycerine, insulin, and liquid antibiotics, most medications are as long-lasting as the ones tested by the military. Placing a medication in a cool place, such as a refrigerator, will help a drug remain potent for many years.”

That is the basic idea. The article even points a finger at pharma companies taking ordinary folk, like you and me for a ride, forcing us to restock medicines over and over again, when there was rarely any use for it. In India it has been reported in exclusive news reports that certain pharma companies take back expired medicines from their wholesale agents and, instead of destroying them, simply repackage them with different expiry dates. This was thought to be a criminal act one kind, but now it seems the pharma companies in question were fully aware of the fallacy of expiry dates and had quickly made the best use of this loophole to recycle old drugs. That this has not affected us negatively is another matter.

What can be done?

Frankly, nothing much can be done. Putting an expiry date would be a legal precondition, which sees the absurdity of a purportedly million-year old rock salt landing up on your dinner table with a six month expiry date. Maybe the system has to be looked into in a different manner. Maybe profiteering of this scale needs to be controlled.

Before that, though, the public needs to be taught the right thing by medical scientists and experts. Somebody has to take responsibility for this.