unappealing to pharmaceutical manufacturers.
The ODA establishes mechanisms of financial sup-
port for pharmaceutical manufacturers through
grants and tax relief, in return for which the man-
ufacturer agrees to produce and market the drug.
Additional grants are available to support research
about rare diseases. In 2005 there were approxi-
mately 1,400 drugs with orphan drug status. The
US Food and Drug Administration (FDA) Office of
Orphan Products Development (OOPD) oversees
orphan drug research.
See also INVESTIGATIONAL NEW DRUG(IND); OFF-
LABEL USE.
outdated drug A DRUGthat is past the manufac-
turer’s listed expiration date. An outdated drug
may be less effective than the unexpired product or
may be harmful. Drugs deteriorate over time. Some
drugs have short effective periods, particularly
those that require refrigeration. Other drugs main-
tain potency for years. The US Food and Drug
Administration (FDA) requires pharmaceutical
manufacturers to determine the length of time a
drug remains at full potency and to incorporate an
expiration date into the drug’s labeling informa-
tion. In general, pharmacists recommend not using
a drug after one year from the date it was opened or
removed from its original packaging (including
preparation or repackaging as a prescription).
No matter what a DRUG’s official expira-
tion date, do not use or take products
that are discolored or obviously deterio-
rated (such as tablets that are crum-
bling) or when there is damage to the
container (such as a crack in a tube or a
broken lid).Factors such as exposure to heat, light, mois-
ture, and air may hasten deterioration, causing a
drug to become less effective even before its expi-
ration date. It is important to store drugs in their
original or prescription containers and in the
appropriate environment. Many people keep med-
ications in a bathroom medicine cabinet, which,
though convenient for remembering to take med-
ications at the prescribed times, is a less than ideal
environment. Most bathrooms are small and
enclosed and experience extreme variations in
heat and humidity as a result of people bathing or
showering. Pharmacists recommend storing drugs,
prescription and over-the-counter, in a cool, dry,
dark location unless the label specifies other stor-
age requirements, such as refrigeration.
See also EFFICACY; OVERDOSE.overdose Consumption of a quantity of a DRUG
in excess of its recommended DOSEor of a combi-
nation of drugs that results in potentiated effects
from any or all of the drugs. Overdose may occur
with prescription or OVER-THE-COUNTER (OTC)
DRUGS. The consequences of an overdose may
range from no apparent symptoms to potentially
life-threatening adverse effects. The severity of the
consequences depends on numerous factors,
including the person’s age, health condition,
amount and kind of drug, whether the person also
consumed ALCOHOL, and to some extent whether
the overdose is intentional or unintentional.Seek immediate medical help for any
suspected overdose. Call 911 or the US
national poison control hotline at 800-
222-1222. Do not induce vomiting
unless a health professional so advises.
Keep the package or container and any
remaining DRUGfor positive identifica-
tion.Unintentional overdose may occur when a per-
son- misreads or misunderstands the dosage instruc-
tions - forgets having taken a dose and takes another
- takes one drug thinking it is another drug
- takes multiple drugs that have the same ingre-
dients - takes a prescription drug and an over-the-
counter (OTC) drug that have the same active
ingredient - takes multiple drugs that interact in ways that
intensify the effects of one or more of the drugs
taken - drinks alcohol or uses illicit substances when
taking the medication
164 Drugs