These comments are made for the purpose of discussion and should NOT be used as recommendations for or against therapies or other treatments. An individual patient is always advised to consult their own physician.
Generic Drugs
Question: Rumors fly about the safety and purity of generic prescripts.
What are the Federal standards for generics? Are all generics
100% compatible to name brands? Are expired name brands
sold as generics? My union is considering a managed care
insurance plan that is generic prescription oriented.
Answer: To answer your last question first, absolutely not! Expired brand name drugs are not sold as generic drugs!
In order to address your question regarding standards used to evaluate generic drugs we need to define several terms.
If two products are “chemical” equivalents it means they contain equal amounts of the same drug. This does not, however, guarantee that they will have the same effect when taken. The way drugs are manufactured can effect how they dissolve and are absorbed by the body. Thus two products are only considered “bioequivalents” if they appear in the blood at about the same
time and amount.
Even if two drugs are bioequivalent, this does not guarantee that they will have the same exact effect on the body – in other words, that they are “therapeutic” equivalents. But in practice it is extremely difficult to prove therapeutic equivalence, and it is seldom necessary, anyway. The FDA usually expects a generic drug to simply be reasonably bioequivalent to the brand
name drug to be approved. “Reasonable” usually means no more than plus or minus twenty percent. This may sound like a lot of variation, but is acceptable with the vast majority of drugs.
So how do pharmacists determine if a generic product is an acceptable substitute for a brand name? Fortunately there are guides which class generics as either A, B or C depending on their bioequivalence. Pharmacies are generally permitted to dispense type A or B generics.
There are a few drugs for which generic equivalents are usually NOT substituted. It is critical to maintain precise blood levels of these drugs. Generics are not used because of doubts about the quality of the generic drugs but simply to insure that blood levels do not rise or fall unexpectedly due to changes in generic product.
Naturally the manufacturers of brand name versions of drugs would rather you did not buy generics. Yet some of these same companies manufacture hundreds of generic products themselves. The vast majority of generic products are quality, reliable products. Generics have been controversial because of several cases of manufacturers submitting fraudulent information to the FDA. Unfortunately no area of human enterprise is completely free from those who would defraud the public. This should not cause consumers to hesitate to use good generic drugs, however.
