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Expired drugs: To take or not to take

Article · December 2011

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4/13/13 The Tribune, Chandigarh, India - Opinions

OPED HEA LTH

Expired drugs To take or not to take

Dr Ravi K Gupta

Expiry dates on the medications and vitamins are a conservative estimate by the manufacturers to
ensure quality, say some studies. In many instances, medicines past their expiry date are safe but
may not be as effective or potent

SHOULD we discard all medicines from our home medicine kit that have
passed their expiry date and replace them?

If someone is administered an expired medicine, is he/ she going to suffer a

serious side effect?

If someone is having a sudden and severe neck or back pain during midnight,
and the only painkiller available in the medicine kit is past its expiry date,
should the patient take it or keep on suffering?

Most of us may have faced these dilemmas at one time or other. But the
question is that what happens to the potency and safety of the drugs that
have passed their expiry dates.

The website of Harvard Medical School (HMS) Family Health Guide says that
the expiration dates on the medications and vitamins are a conservative
estimate by the manufacturers to ensure quality. In most instances, expired
medications are safe but may not be as effective or potent once past their
expiry date.

FDA ruling

Before 1979, it was not mandatory for drug manufacturers to

mention the expiration date on the products. For the first time in
1979, the Food and Drug Administration (FDA), US, made it
necessary under the law for all drug manufacturers to mention
the date up to which the full potency and safety of the drug
was certified. This resulted into the start of a new era of
discarding drugs that had passed the date of expiry mentioned
on their packing. Thus it caused huge losses to the bulk
purchasers of the drugs, especially in government health
departments and the US Army, forcing them to replace the
unused expired drugs with a fresh stock.

In 1985, this loss was noticed by the US Army authorities when

they were faced with the task of destroying and replacing the stockpiled expired drugs worth more than a
billion dollars. This triggered the process of testing the efficacy and safety of the expired drugs. The task of
testing was assigned to the FDA by the US Army.

Accordingly, the FDA tested more than a hundred prescriptions and over-the-counter medications and
observed that 90 per cent of the expired drugs were still safe and potent; the oldest drug tested had expired
15 years back at the time of testing. The study pointed out that the expiry date did not really indicate a point
at which the medication was no longer effective or had become unsafe to use. This report was published in
the Wall Street Journal (March 29, 2000), which was reported by Laurie P. Cohen. At present, there is a
programme being run jointly by the Department of Defence and the FDA, US, known as “Shelf Life Extension
Program” (SLEP) that is meant to defer drug replacement costs for date-sensitive stockpiles of
pharmaceuticals by extending their useful life beyond the manufacturer's original date of expiry. The SLEP
started in 1986 and has started providing online service since 2005.

Dos and Don’ts

Shelf life
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4/13/13 The Tribune, Chandigarh, India - Opinions

Most outdated medications, whether

Taylor and others in a paper titled “Stability profiles of drug prescription or over-the-counter, are
products extended beyond labelled expiration dates” usually not harmful. If the medications
presented the data from the Department of Defence/US have been stored under good conditions,
Food and Drug Administration (FDA) Shelf Life Extension they usually retain much of their potency
Programme, which tests the stability of drug products past for at least one to two years following
their expiration date. The paper presented in 2002, showed their expiry date, even after the
that 84 per cent of 1,122 lots of 96 different drug products, container is opened.
stored in the military facilities in their unopened original One should not consume any pills that
container, were expected to remain stable for an average of have become discoloured, turned
57 months after their original expiration date. Some US Army powdery, or smell bad; any liquids that
studies on Valium, for example, show that the drug is stable appear cloudy or filmy; or any tubes of
and completely safe and effective for up to eight years after cream that are solidified or cracked.
manufacture. Tablets of ciprofloxacin, an expensive To help maintain potency, the
antibiotic, were found completely safe and effective when medications should be stored in a closet
tested nine and half years after the expiry. or cabinet located in a cool and dry room.
The medicine kit should not be stored in
An issue of The Medical Letter quoted not only the above the bathroom where the heat and
study but also of others showing expensive medications like humidity from hot water showers/ steam
Amantadine and Rimantadine maintaining their stability after can cause medications to break down,
storage for 25 years under ambient conditions and retained lose potency and, occasionally, even
full anti-viral activity after boiling and holding at 65-85° C become harmful.
for several days. Regenthal and coauthors in 2002 observed Similarly, their storage in the kitchen next
that the drug Theophylline, in tablet form, showed 90 per to the gas stove, washbasin or
cent stability even after 30 years beyond the expiry date. dishwasher is not advisable.
It should be ensured that the bottles are
The Medical Letter also quoted that most drugs stored under tightly sealed after use.
controlled conditions retain 70 per cent to 80 per cent of Also, the medications should not be mixed
their potency for one to two years after the expiration date, in one container because chemicals from
even after the container has been opened. But it must be different medications can interact to
noted that the current US Pharmacopoeia [USP] standard is interfere with potency or cause toxic side
generally 90 per cent potency. With new individual pill effects. If two or more medications have
packaging techniques, however, it is highly likely that USP been mixed, they should be discarded.
acceptable potency would be the norm over the same time A few medications, like insulin and some
period. liquid antibiotics, do degrade quickly and
should never be used beyond the expiry
Although in certain cases, the effects of expiration of a drug date.
has been observed to be in the form of some loss of potency
If there are any doubts about the safety
of the drug over the period of time, which can range from as
little as 5 per cent of loss of potency to 50 per cent loss of or potency of a particular expired drug, it
potency, but many drugs are likely to have a reasonably is wise to consult a pharmacist who does
good potency even after five to10 years of expiry. However, not have any conflict of interest.
in the case of some antibiotics, the chemical has been
reported to get transformed into a new form after the
expiration date, which may be harmful. This was reported by
Drug disposal
Frimpter and others in the Journal of American Medical
Disposal of the expired drugs properly is
Association in 1963 (JAMA. 1963;184:111-113) in the case
equally important to avoid the harmful
of expired tetracycline that resulted into side effect on the
environmental effects and prevent
kidney although the observation and conclusions of the
accidental use of discarded expired drugs
authors are being contested by some other medical
by the children and animals. A 1996
scientists.
report of how expired medications are
In a recent article, Richard Altschuler has quoted Francis being disposed of found that 1.4 per cent
Flaherty, a former director of the testing programme of FDA of respondents returned medications to a
saying, “expiration dates put on by manufacturers, typically pharmacy, 54 per cent disposed of
have no bearing on whether a drug is usable for longer. A medications in the garbage, 35.4 per cent
drug maker is required to prove only that a drug is still good flushed medications down the toilet or
on whatever expiration date the company chooses to set. sink, 7.2 per cent did not dispose of
The expiration date doesn't mean, or even suggest, that the medications, and 2 per cent related that
drug will stop being effective after that, nor that it will they used all medications before
become harmful. Manufacturers put expiration dates on for expiration.
marketing, rather than scientific reasons. It’s not profitable Ideally, one should follow the advice and
for them to have products on a shelf for 10 years. They instructions for the disposal of the expired
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4/13/13 The Tribune, Chandigarh, India - Opinions

for them to have products on a shelf for 10 years. They
want turnover." Mr Altschuler has also quoted Joel Davis,
who has been former FDA expiration-date compliance chief
as “with a handful of exceptions - notably nitroglycerin,
insulin, and some liquid antibiotics - most drugs are probably
as durable as those the agency has tested for the military.
Most drugs degrade very slowly. In order to maintain the
potency and safety of the drugs, however, it is mandatory
that these are stored in a refrigerator and not exposed to
direct sunlight, heat and humidity.”
Thus, it is now an undisputed fact that in the case of liquid
antibiotics, nitroglycerine, insulins and the drugs meant to
save life-threatening situations, one should not take the risk
of taking the drugs that have crossed the expiry dates.
Administration of majority of other drugs, however, beyond
the date of expiry is very unlikely to result into any serious
side effects.
Safety strategies
In the light of the foregoing information, the question
remains as to what should be done with the drugs that have
passed the expiration dates mentioned by the drug
manufacturer, especially in the case of bulk purchasers in
the government sector. The US military has devised a programme of extension of shelf life of the expired drugs
by getting them tested from the FDA.
instructions for the disposal of the expired
medications as rendered by the
manufacturer, if they are provided with.
However, if there are no such
instructions, it is advisable to take out
the medicines out of their containers and
mix them with something like cat/ dog
litter or dirty household waste to which
the children and pets are not attracted
to.
Finally they should be disposed off after
sealing them in plastic bags. The expired
medicines should not be flushed down the
toilet unless specifically instructed to do
so because of the earlier reported risk of
the resistant bacteria in the aeration
tanks of sewage treatment plants by the
antibiotic substances present. The
exceptions to the rule are narcotics and
controlled substances, which are often
flushed to prevent unintentional use,
overdose and illegal abuse.

It may be worthwhile for the developing countries also to explore the possibility of identifying/ developing such
national organisations like FDA so that if the need arises, such shelf extension programmes can be undertaken.

Till the strategies of testing of such medications are developed, the individual users can check the advice
rendered by the Harvard Medical School on its website:

http://www.health.harvard.edu/fhg/updates/update1103a.shtml and by Johns Hopkins on its website:

http://www.johnshopkinshealthalerts.com /alerts/prescription_drugs/
JohnsHopkinsPrescriptionDrugsHealthAlert_677-1.html

The writer is Associate Professor, Orthopaedics, Government Medical College Hospital, Chandigarh

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