What does the expiration date on the drugs mean and are expired

medicines Safe, Dangerous or Ineffective?

What is an expiry date?

Expiry date is a date given by the manufacturers to which it warrants the full potency of an NHP

[Natural Health Product]. The safety of intake of the medicine and potency per dosage unit is

dictated by this date. It is required by the drug manufacturers to stamp an expiry date on all over-

the-counter (OTC) medicines to make sure that we are getting a safe medicine. However, these

days, very few understand the processes used behind the estimation of the expiry date and many

feel it is just a ploy by the big pharmaceutical companies to prevent hoarding of these medicines

when their rate is low.

Source: Drugs.com

Calculation of expiry date

A series of quality standards are established for each new drug before FDA approves it.

The clinical trials made for calculating expiry date are the manufacturing and testing

specifications. These include upper jaw and lower limits for the amount of Active

Pharmaceutical Ingredient (API) in each dose (e.g. 500mg per tablet).

After this, stress testing is done which tells about the stability of the drug and also

illustrates its degradation pathway.

There are temperature tests that are also performed to find out the ideal temperature

required to keep the potency of the medicine in check (for example, store below 20°C).

For liquid and inject-able drugs, bacterial and purity and chemical stability tests are also

performed.

And finally an expiry date is given: the date to which the manufacturer warrants the original

product characteristics will be retained.

Is it safe to have expired medicines?

A case study:

The first question that strikes our mind is whether they are potentially harmful if

consumed. The kidney damage caused by degraded tetracycline in 1960’s is drilled into

every pharmacist’s brain. But after that there was no other documented case.

A change in thought after research:

Earlier it was thought that the effectiveness of some medicines decreases over time but

now a thorough research has revealed that much of the original potency remains the same

for a few years after the expiration date. The Department of Defense/FDA Shelf Life

Extension Program tested 122 different products, stored unopened in their original

containers. They found that about 88% were stable for at least one year after expiry with

an average of 5 years after expiry.

When and when not to trust expired medicines:

Excluding certain prescription medicines like nitroglycerin, insulin, and liquid antibiotics,

most drugs stored under reasonable conditions retain at least 70-80%of their original

potency for at least 1-2 years even after the container has been opened.

What effects can expired medicines have?

The surprising discovery: There has been no conclusive proof to report that medicines start taking the reverse effect

after their expiry, but rather surprisingly, medicines have found to work with almost the

same potency with which it was designed even a long time after the expiry date.

Researchers examined eight prescription drugs that expired between 28 and 40 years ago.

They found that most were just as potent as when they were made.

The side effects:

However, it is noted that antibiotics change color and exhibit opposite characteristics

after their expiry. There may also be side effects, which will be mentioned on the cover

itself. these side effects are at a 2% occurrence during the potent period and the

occurrence of side effects is shown to increase manifold after the expiry date. Side effects

are, for example, headaches, nausea, light headedness, etc.

The decomposition effect:

There have also been few cases where the medical composition has decomposed,

rendering the medicine useless after expiry.

Does this mean we should start taking expired medicines?

Based on the above discussions and conclusions, it might seem logical to stack up expired

medicines and use them, however, the effects are varying and no effective conclusion has been

reached. And hoarding the medicines up, without reading the usage and potency of the medicine

is more harmful than useful. Therefore, it is not advisable to intake expired medicines, without

fully understanding the consequences, because making sure that the medicine has not lost its

potency and it does not have decomposing elements requires very careful analysis. Instead, doing

off with the expired medicines and buying new ones is better for health reasons, which is

primarily why medicines are used.

Offcial Resource: mChemist