Since 1979, the Food and Drug
Administration (FDA) has required pharmaceutical manufacturers to
provide expiration dates on all their products. For the majority
of drugs sold in the United States, these dates range from 12 to
60 months from the date they are manufactured.
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.
Stability Testing
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.
It is important to note that the manufacturers’
expiration dates apply only to the original packaging of the drug,
and that once opened these dates no longer apply. Each state has
different requirements, but all pharmacists must give the consumer
some sort of expiration date, sometimes called a “beyond use” date.
This date typically is 6-12 months from the date the drug is dispensed,
but may be shorter depending on the type of medication or a manufacturer’s
expiration date.
The Importance of Storage
Medications last only as long as their storage conditions are favorable.
Drugs can lose their potency long before the expiration date if
exposed to oxygen, heat, light, or humidity. In order to maintain
their potency, medications should be stored in a place that is dry,
cool, and dark. Despite popular practice, this means that your bathroom
medicine cabinet should not be used, because its high level of humidity
can cause medications to break down and lose their effectiveness.
The FDA also recommends keeping medications in their original containers,
away from other substances that might be mistaken for it. Specific
instructions should always be followed. For example, nitroglycerin
should be kept away from light. Your pharmacist may also give you
additional storage instructions in the form of a label on the bottle
or on a handout.
Studying Shelf Life
The accuracy of drug expiration dates has been the subject of much
discussion. Since 1987, the FDA has been administering a program
called Shelf Life Extension Program (SLEP) for the military. The
program tests military stockpiles of drugs to determine stability
after the expiration dates have passed. According to the report,
of 119 drug products tested, all except for four or five were stable
beyond their original expiration dates. Some were extended for as
long as 10 years beyond their expiration dates.
As a consumer, this means you need to follow expiration
dates or beyond use dates very carefully. The impact of the SLEP
program was that drugs stored in their original containers in ideal
storage conditions can last for long periods of time. But once exposed
to the environment, there is no way to predict their effectiveness.
Unfortunately, once you bring your medications home from the pharmacy,
they are no longer being stored under such controlled conditions.
Variability
Drugs vary widely in terms of dosage, form, and stability. Some
drugs, like pediatric liquid antibiotics, insulin, and certain injectables
will expire more quickly than medications in other forms, such as
tablets. The SLEP program found solid dosage forms did better in
stability testing than injectables. The program demonstrated that
there is a lot of variability even within one product, different
lots of the same drug tested differently.
So, remember, your medications will work only as
well as they are handled. Taking them safely means storing them
properly, reading all specific instructions carefully, and not using
them after the recommended amount of time or expiration date.
Source
Interviews
We plan to do einterviews with MBBS doctors to understand 4 things
1) Tests or questions you ask in first few meetings
2) What it means in medical terms
3) What it means in non medical terms
4) What should the patient or care takers do
We might interview Aurvedic doctors, homeopathic doctors, Yoga teachers
on this health issue
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