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What are expiry dates for medicines?

Q: When tablets are prepared under harsh conditions, what happens to drugs in the tablets after the expiry date? How is it decided?

Krishna: Expiration dates are basically guidelines. Your medications may expire before the expiration date if improperly stored, or they may last well beyond their expiration date, as some studies have shown. While most drugs do not become dangerous when expired, they can still pose a threat to your health. Over time, drugs lose their potency. Using a drug past its expiration date may affect its quality and effectiveness (2).

Usually drugs are well tested before releasing into the public domain. So scientists themselves decide how stable a drug can be in the environment it is packed, transported, delivered and stored in other conditions. These things are taken into account to decide the expiry date.

Pharmaceutical manufacturers determine a drug’s shelf life, or expiration date, through stability testing. This type of testing ensures that a drug’s potency and integrity are intact over a specific amount of time, which becomes the expiration date. Several factors can influence these dates, including type of active ingredients, storage conditions, preservatives, and the kind of container the drug is stored in (2).

Proper storage is one way to help make sure your medicines will remain safe and effective up to their expiration date. Be sure to read the label to see if there are specific storage instructions for your medicine. Certain medicines need to be stored in the refrigerator and others cannot be exposed to high temperatures. Improper storage – such as a damp bathroom cabinet – can contribute to decreased effectiveness in medicines that have not reached their posted expiration date. For most medicines, to help ensure the proper shelf life of your medicine, it is better to store medicine in a cool, dry place such as a dresser drawer, storage box, closet shelf, or kitchen cabinet.

When storing medicine in a kitchen cabinet make sure that it is away from hot appliances and the sink due to changing temperatures and humidity, which can affect the medicine. When storing medicine in a high traffic area, like a kitchen, care should be taken to prevent access by children at risk of accidental poisoning or others who may be tempted to take for abuse/misuse (3).

The drug is likely to lose some potency after the expiration date, but it is not clear how much potency is lost over a certain period of time past expiration dates. It depends on the conditions it is stored in. Placing medication in a cool place, such as a refrigerator, will help some drugs to remain potent for many years (1).

Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth and sub-potent antibiotics can fail to treat infections, leading to more serious illnesses and antibiotic resistance (3).

If you have medicines that have passed their expiry date, take them to your pharmacist, who can dispose of them safely for you.You should never throw unused or expired medicines in the rubbish bin or flush them down the toilet.

Footnotes:

1. https://ejim.springeropen.com/articles/10.4103/ejim.ejim_110_19#:~:....

2. https://www.winchesterhospital.org/health-library/article?id=73446#...'s,which%20becomes%20the%20expiration%20date.

3. https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expi....

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