Lata rushed into my consulting room with tears rolling down her cheeks. She was angry and visibly
upset. Lata’s both kids were delivered by me. She was an experienced mother. She was very diligent
about the baby’s health and never missed on the vaccination schedule. She used to take her kids to
the same pediatrician for years together. On one fine day, her pediatrician informed her that the
child was given a vaccine which had expired one month back…and Lata was shattered. Like many of
my patients who consider me to be their “friend- philosopher- guide” besides being their
gynecologist, Lata came to me for help and guidance.
Lata was literally fuming. She said. “I trusted that doctor so much and how could she be so negligent
to me and my child?” It was a clear case of medical error. The pediatrician was extremely apologetic
and felt sorry about the whole incidence. We know that medication errors are the commonest errors
in healthcare. Actually. this mistake was caused because of a goof up in the pattern of writing expiry
date. We know that the Americans write the date in “mm/dd” format and In India we use “dd/mm”
format. Precisely this was the cause of this blunder.
Lata was extremely worried and tensed about the ill effects of the expired medication. “Doctor, I
even check a loaf of bread for the “consume best before” date. I don’t allow anyone to eat even a
slice after that date. We make fresh food every day. We don’t consume “Basi” (stale) food at home.
And look here. My little one has been injected with a vaccine which has expired a month back!!!”
Lata blew off.
She was not wrong at all. Most people believe that medication post expiry, like food, may rot or turn
into some poisonous substance and be very harmful if consumed. So is this true? What is the
meaning of expiry date? This article focuses on these issues.

(source: google)
A few years back US air force found a huge stock of medications worth thousands of dollars stored in
odd places like bathrooms at various locations in the country. They had just dumped those expired
medicines as they did not know what to do with them. Purely out of interest some intelligent
pharmacologist decided to conduct a study on these drugs. And Bingo! Almost 90% of the medicines
had retained their potency although they had expired few months to few years back. On the basis of
these finding US air force and Food and Drug Administration created a programme called “Shelf life
extension programme”. Under this programme. the expired medicines were rechecked for potency,
revalidated and re-used for medical treatment successfully. It saved millions of dollars for the
government. Few medicines … sprays, liquids had more chance of losing their potency as compared
to injections and vials containing medicine in powdered form. But one thing came out loud and clear
… none turned into poisonous substances or created harm!
The system of writing expiry date began in in the United States in 1978. The same system was
followed across the world. So what does the expiry date mean? Is it the date beyond which medicine
becomes completely ineffective? Is it the date after which the drug will rather cause harm? The
answer to both the questions is “No”. The expiry date is the date beyond which the company does
not assure of full potency of the medical ingredients. It is a conservative estimate by the company. In
a way, it helps the sales of the company as expired medicines will be discarded and new stock will be
ordered! In order to strike the right balance between cost and benefit, the American Medical
Association asked FDA to review the system of giving expiry date in 2006.

Few clear messages emerge out of research on this topic:

  •   Medicines do not get stale or rot or turn poisonous post-expiry.
  •  The above sentence may not hold true especially in case of syrups containing substances like
    glucose.
  •  If the bottle/ vial is opened then bacteria can grow into it. But if the injections or vials
    containing dry powders are stored correctly in a sealed pack they cannot “rot” or get
    infected.
  • The expired medications may not have the same potency. Hence one may need to revalidate
    the potency or simply take an additional dose.
  •  In nutshell, if expired medications ( tablets/ injections) get used inadvertently, no guarantee
    can be given about its effectiveness but it will not cause harm or untoward effect too.

So what did Lata do? Lata met two pediatricians and discussed the matter. Both suggested that the
child should be given another dose of vaccine. Sadly, the child had to take additional injection but
Lata was sure that there is no harm caused to the child. Her pediatrician gave an additional dose of
vaccine to the baby. Lata continues to follow up with the same doctor. She and her doctor both have
become more vigilant about the medications as they both know that human errors are possible in
any one’s hand.

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