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Are Expired
Drugs Still Safe to Take?
Medically reviewed by Leigh Ann Anderson, PharmD
· Can I safely
take a medication if it has reached the drug expiration date?
· Are there
recommendations about the best way to store my medications?
· Which drugs
should never be used past their expiration date?
For many patients, these questions arise because
medications can be expensive and it is costly to frequently replace expired but
unused medications.
What does an expiration date
mean?
The expiration date is the final day that the
manufacturer guarantees the full potency and safety of a medication.
Drug expiration dates exist on most medication
labels, including prescription, over-the-counter (OTC) and dietary (herbal)
supplements.
U.S. pharmaceutical manufacturers are required by law
to place expiration dates on prescription products prior to marketing.
For legal and liability reasons, manufacturers will
not make recommendations about the stability of drugs past the original
expiration date.
However, for most drugs, it's just an arbitrary date,
usually 2 or 3 years out, that the manufacturer selects to test drug stability.
In all actuality, the stability of the drug may be
much longer, but no one tests it.
The expiration date of a drug is estimated using
stability testing under good manufacturing practices as determined by the Food
and Drug Administration (FDA).
Drug products marketed in the US typically have an expiration
date that extends from 12 to 60 months from the time of manufacturer.
Once the original container is opened, either by the
patient or the health care provider who will dispense the drug, that original
expiration date on the container can no longer be relied upon.
However, the actual shelf life of the drug may be
much longer as stability studies have shown.
At the pharmacy, "beyond-use" dates are
often put on the prescription bottle label given to the patient.
These dates often say "do not use after..."
or "discard after..." and are required by the Board of Pharmacy in
many states.
These dates are typically one year from the date of
fill. But why would these expiration dates be different?
According to the manufacturer, the stability of a
drug cannot be guaranteed once the original bottle is opened. Heat, humidity,
light, and other storage factors can affect stability.
Plus, pharmacies, both retail and hospital, nursing
homes, and consumers toss away billions of dollars of medications each year based
on stamped expiration dates on stock bottles.
In fact, according to a report from Allen, hospitals
alone discard over $800 million in drugs annually.
The United States Pharmacopeia (USP), the body that
sets the standards for pharmaceutical quality in the U.S., recommends using
"beyond use" dates.
The "beyond use" date would never be later
than the expiration date on the manufacturer's bottle.
However, the expiration date on the prescription
bottle from the pharmacy is usually one year from the date it was filled;
again, another arbitrary date.
Do expired medications lose
their potency?
The American Medical Association (AMA) concluded in
2001 that the actual shelf life of some products is longer than the labeled
expiration date.
The AMA stated the best evidence resides in the Shelf
Life Extension Program (SLEP) undertaken by the FDA for the Department of
Defense.
The original purpose of the SLEP program was twofold:
to determine the actual shelf life of stockpiled military medications for
future use, and to save government dollars.
Over 3000 lots, representing 122 different drug
products, were assessed in the SLEP program. Based on stability data, expiration
dates on 88% of the lots were extended beyond their original expiration date
for an average of 66 months.
Of these 2652 lots, only 18% were terminated due to
failure. Examples of common drug products that were tested with no failures
included amoxicillin, ciprofloxacin, diphenhydramine,
and morphine sulfate injection.
Drug expiration extension dates on
these products ranged from 12 months to 184 months (over 15 years). Biologics
are not included in the SLEP program.
These results suggest that many drug products may
have extended shelf lives beyond their expiration date.
However, it is difficult for anyone consumer or
health care provider to know which product could have an extended shelf life.
The ability for a drug to have an extended shelf life
would be dependent upon the actual drug ingredients, presence of preservatives,
temperature fluctuations, light, humidity, and other storage conditions.
Additionally, the drug lots tested in the SLEP
program were kept in their original packaging.
Once a drug is repackaged into another container, as
often happens in the pharmacy, the shelf-life could decline due to
environmental variations.
Is it safe to take expired
medications?
Studies and case reports are lacking on this topic.
In 1963, a report was published that tied
degraded tetracycline use
with a form of renal tubular (kidney) damage known as "Fanconi
Syndrome"; however, that formulation of tetracycline in no longer marketed
in the U.S., and many medical experts question the results of this case report.
Solid dosage forms, such as tablets and capsules,
appear to be most stable past their expiration date.
Drugs that exist in solution or as a reconstituted
suspension, and that require refrigeration (such as amoxicillin
suspension), may not have the required potency if used when
outdated.
Loss of potency can be a major health concern,
especially when treating an infection with an antibiotic.
Additionally, antibiotic resistance may occur with
sub-potent medications.
Drugs that exist in solution, especially injectable
drugs, should be discarded if the product forms a precipitant or looks cloudy
or discolored.
Expired medications that contain preservatives, such
as ophthalmic (eye) drops, may be unsafe past their expiration date.1 Outdated
preservatives may allow bacterial growth in the solution.
Can you use an expired EpiPen?
The manufacturer states EpiPen autoinjectors
should not be used after the expiration date as the epinephrine has been shown
to lose its potency.
Epipens are used in life-threatening situations like
anaphylaxis, so there can be a major health threat with an expired EpiPen.
However, 2017 research on expired EpiPens has been
published.
A small evaluation of almost 40 expired, unused
EpiPens gathered from patients showed that the pens retained 80% of their
initial dose of epinephrine, some for up to four years past the expiration date
on the device.
The lowest level of epinephrine was found in an
EpiPen Jr. 30 months past its expiration date; it retained over 80% of it's
original epinephrine dose.
About 65% of the EpiPens and 56% of the EpiPen Jrs.
contained at least 90% of their initial dose.
In a life-threatening allergic situation, if there is
no other option, use of an expired EpiPen should be considered if it is the
only auto-injector available and there are no discoloration or precipitates
seen in the solution.
In this case, the potential benefit of saving a life
is greater than the potential risk of death by not using it all.6,11
Which medications are unsafe
after their expiration date?
There's really no way to know unless drugs are
tested, but here are some common sense measures:
· Insulin is used
to control blood sugar in diabetes and may be susceptible to degradation after
its expiration date.
· Oral nitroglycerin
(NTG), a medication used for angina (chest pain), may lose its
potency quickly once the medication bottle is opened.
· Vaccines, biologicals or
blood products could also be subject to quick degradation once the expiration
date is reached.
· Tetracycline
may produce a toxic metabolite, but this controversial among reseachers.8
· Medicines that
looks old: powdery or crumbling medicine, drugs with a strong smell, or dried
up medicine (as in the case of or ointments or creams) should be discarded.
Proper storage of medications may help to extend
their potency. The bathroom and medicine cabinet are not ideal places to store
medications due to heat and humidity.
Similarly, medications should not be left in a hot
car or glovebox, or in freezing weather. Medications remain most stable in dry,
cool spaces away from light.
Keep the prescription bottle caps tightly closed and
always keep medications out of reach of children and pets.
Another important point, especially considering the
national opioid epidemic.
Discard unused or expired controlled substances like
hydrocodone and acetaminophen (Vicodin, Lotab, Norco) or oxycodone (Oxycontin)
as soon as possible due to the risk for overdose, theft, or diversion of the
medication.
Plus, learn about the National Prescription Drug Take
Back Day held twice per
year in your city as a safe way to dispose of these
prescription medications.
Can I take an expired
medication?
Should patients use expired medications or not? It's
always best to use medications that are NOT expired; it's just the safest
route.
If a medication is essential for a chronic and
potentially life-threatening disease, for example, a heart condition, cancer
treatment, seizure, or life-threatening allergy, it is probably wise to get a
new prescription before it expires and keep up with refills as needed.
However, if a medication is needed, and the patient
is not able to replace the expired medication, there is no evidence that it is
unsafe to take the medication in most cases.
The patient should be aware that it may not produce
the desired therapeutic effect. If this is the case, a new prescription is
needed.
If an expired medication is for a minor health
problem, for example, for a headache, hayfever, or mild pain, it may also be
safe to take it, although drug potency might not be 100% and it may not work as
well.
For example, if using ibuprofen (Advil) or
acetaminophen (Tylenol) that's outdated does not relieve your headache, it may
have lost its potency.
Research has shown many military stockpile
medications retained 90% of their potency in their original stock bottle.
However, storage conditions of these medications were
optimized for temperature and humidity, and probably do not mimic the typical
storage conditions of the average household prescription bottle.
If an expired medication is taken, and the patient
notices the drug has no effect, the medication should be replaced. Some drugs
are probably less likely to be safe if they're expired:
· a biologic
product
· insulin
· a refrigerated
liquid
· eye drops
· injectable
· a specially
compounded medication
· if it looks
like it is degraded or cloudy, or has a noxious smell, it should be discarded
and replaced.
If questions still remain about how to handle an
expired medication, it is wise to speak with your pharmacist or physician, who
can offer additional information and advice.
Leigh Ann Anderson, PharmD
Senior Editorial Pharmacist
BS, PharmD, with specialized
residency in Drug Information.
University of Florida - Shands Hopsital; Post-doc residency, Drug Information 1992 – 1993.
Campbell University College of Pharmacy; PharmD, Pharmacy 1990 – 1992.
University of Florida - Shands Hopsital; Post-doc residency, Drug Information 1992 – 1993.
Campbell University College of Pharmacy; PharmD, Pharmacy 1990 – 1992.
The Drugs.com editorial team is responsible for creating in-depth
articles and to regularly review clinical information provided by various
trusted medical publishing partners.
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