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Brand Name and Generic Game
You've no doubt picked up
a prescription that bears a different name than the one your doctor prescribed
and than the one you dropped off to be filled at your local pharmacy. You’ve
probably asked yourself "Should I switch from a brand name medication to a
generic? Except for price difference, are there other differences between
brand medications and generic medication?”
When a pharmaceutical company develops a generic medication, FDA approval
requires that the it contain the same active ingredients, strength, dose, and
route of administration (bio equivalence) be used to treat the same conditions
and symptoms, in addition to having the same labeling information as the
brand-name medication (therapeutic equivalence).
The main factors for a label of bio equivalency is that the generic has a
comparable rate and extent of absorption when given at the same dose under
similar conditions and that it contain equal amounts of the same therapeutically
active ingredients in identical dosage forms as the brand name drug.
But brand name and generic similarity doesn't stop there. There is also the
concept of confirming therapeutic equivalence, which, in this case, occurs after
the generic is proven bio equivalent. Therapeutic equivalence is assigned when
the generic medication has the same clinical effect and safety profile when
administered to patients under the conditions specified in the brand name
labeling. Thus both therapeutic and bio equivalence must be met. According to
the FDA, substituting brand name for generic medication is safe because of their
proven therapeutical and bio equivalency and continued monitoring.
While the FDA does not require a generic drug to undergo repetitive and very
costly clinical testing of their active ingredients or dosage, as these have
already found to be safe and effective through clinical trials on its brand name
counterpart, they do require that bio equivalency or "batch-to batch" studies be
performed to ensure the active ingredients' identity, strength, purity, and
quality.
Otherwise, permitted differences between generic and brand name medications
could include characteristics such as shape, delivery system (capsule, tablet,
liquid), excipients (corn starch, pre-gelatinized starch and starch hydrolysates),
food coloring and flavoring, and preservatives. These differences may be the
cause of some adverse effects or decreased effectiveness that a small percentage
of individuals experience. In these instances, your physician can prescribe
brand name medications as "medically necessary" so to ensure the generic brand
is not substituted.
The biggest differences that may affect your decision to take generic or brand
name medication are cost and insurance coverage. And because of medical
financial burdens that many patients face, trying generic medications first and
using brand name medications, in the event that you might experience an adverse
effect or unsatisfactory effectiveness, is a very reasonable and wise route to
chose.
By Dr. Yong H. Tsai
Published in The Daytona Beach News-Journal
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