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A Cure By Any Other Name

How generic drugs stack up against the brand-name originals

FRIDAY, April 12, 2002 (HealthDayNews) -- Are you and your family filling more prescriptions today than you did last year? Or the year before? If so, you're not alone.

Americans 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.

Perhaps more 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 in magazines.

"I think 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.

One reason 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?

The answer 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.

"A generic 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.

And Victor 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.

The first, 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.

The second 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.

"Bio-equivalent 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.

For example, 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.

All-in-all, when regulations are followed, most pharmacists give high marks to generics.

Some doctors, however, aren't quite as enthusiastic when it comes to making the big switch.

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.

Reporting in 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.

Policies set 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.

Similarly, 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."

What To Do

While it's 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.

If, however, 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.

SOURCES: Victor Cohen, R.Ph, BS, Pharm.D, pharmacy manager, department of pharmacy services and department of emergency medicine, Maimonides Medical Center, Brooklyn, N.Y., and assistant professor, College of Pharmacy, Long Island University, New York; policy statements on generic drugs from FDA Office of Generic Drugs, Center for Drug Research and Evaluation; October 2001 Journal of the American Pharmaceutical Association
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