or Brand Name?
By Colette Bouchez, HealthScoutNews
Are you and
your family filling more prescriptions today than you did last year?
Or the year before? If so, you're not alone.
People have been
flocking to pharmacies in record numbers during the past decade, with
the amount of prescriptions skyrocketing -- up from just under 2 billion
a year in 1992, to 3 billion annually in 2000, according to the National
Institute of Health Care Management Foundation.
important, studies show that today, nearly 70 percent of those prescriptions
are being filled with generic drugs -- the "off label"
versions of the brand name medications so many of us see on TV and
it's safe to say that more people today are taking generic drugs
than brand name drugs. And for most people, this works out extremely
well," says Victor Cohen, pharmacy manager at Maimonides Medical
Center in Brooklyn, N.Y.
is price: Generics often cost substantially less than brand name
drugs. According to the Congressional Budget Office, consumers can
save up to $10 billion a year from retail pharmacies if they
swap brand names for their generic equivalents.
But how do
generic drugs stack up against the more expensive brand names?
depends a lot on whom you ask.
The U.S. Food
and Drug Administration says there's virtually no discernible difference
between the two types of drugs, thanks in no small part to the regulations
the agency laid down in regard to generic approvals.
drug is identical, or bio-equivalent, to a brand name drug in dosage
form, safety, strength, route of administration, quality, performance
characteristics and intended use, according to the FDA's Center
for Drug Evaluation and Research.
Cohen is quick to add that companies that manufacture generic drugs
have to prove to the FDA that their versions meet three important
standards before gaining market approval.
he says, involves content and uniformity, factors that ensure the
main ingredient in the generic drug is identical to the brand name
and that it is not altered by the manufacturing process.
and third standards involve what are called "bio-equivalents"
and "therapeutic equivalents," meaning the generic drugs
must prove they perform in the body the same way as the original.
means that the generic drug is absorbed and used by the body in
the same way as the brand name drug. Therapeutic equivalent means
the generic has to perform in the same way, and in the same amount
of time as the original," Cohen says.
if a brand name pain reliever is supposed to begin acting on your
aching knee within 30 minutes, and keep on working for six hours,
then the generic version must do the same to gain FDA approval.
when regulations are followed, most pharmacists give high marks
however, aren't quite as enthusiastic when it comes to making the
In a comprehensive
analysis of a number of physician-studies concerning the use of
generic drugs, researchers at the University of Michigan concluded
that doctors are only "mildly positive" about the use
of generic drugs. And they're most adamant that substitutions not
be made without their consent.
the October 2001 issue of The Journal of the American Pharmaceutical
Association, the researchers said that after reviewing policy
statements on generic drugs by a number of major medical organizations,
only the American Academy of Pediatrics (AAP) appeared somewhat
in favor of making the switch. The AAP "supports the concept
of prescribing the least costly medication if safety and efficacy
are not compromised," the Michigan researchers reported.
forth by the American Academy of Family Physicians and the American
Osteopathic Association oppose any substitution of brand name drugs
with their generic equivalent without the doctor's permission.
the American Medical Association recently reaffirmed "its opposition
to the revision of state laws and pharmacy regulations which prohibit
unauthorized substitution of prescription drug products as contrary
to the public interest."
likely that a generic drug will offer you benefits equal to the
brand name version, experts say the swap should never be done without
your approval -- and your doctor's OK.
you want a generic drug, simply ask your doctor to make the substitution
when he or she writes your prescription. Unless there's a specific
reason, most physicians will comply.
To learn more
about generic drugs, visit the FDA's Office
of Generic Drugs. Or, get a fact sheet on generic drugs from
the Federal Trade Commission.
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