Ch 1, Lesson 4: Name Brand vs Generic Drugs Flashcards
What is the most telling sign in a drug name that indicates it is a generic or brand name?
Generic drug names will have similar endings based upon what drug class they belong to.
Name brand drugs will have catchy names that are more memorable to their generic counterpart.
What 4 factors must generic drugs be the same as their brand name counterpart?
- Bioequivalent active ingredient
- Dosage, strength, and route of administration
- Labeling and manufacturing standards
- Monitoring of adverse events
What is an active ingredient?
An active ingredient is the specific component of a drug that accomplishes the treatment or prevention of disease.
According to the Food & Drug Administration (FDA) in the United States, a generic drug must be bioequivalent with its brand-name drug. What does it mean to be bioequivalent?
Bioequivalence is when the amount of active drug that reaches the patient’s bloodstream in the generic medication must be equivalent to that seen in the original branded medication.
What dosing, strength, and administration regulations does the FDA enforce for generic medication?
Generic medication must be identical in dosing, strength, and route of administration to the brand name medication.
What is required of the labeling and manufacturing of generic drugs?
It must have similar labeling and meet the same strict manufacturing site specifications as the branded product.
Do generic medications have to go through the same monitoring of adverse effects as the branded medication?
Yes
What are the 2 main differences between generic and branded drugs?
- Price
- Inactive ingredients
Generic drugs are approximately 80 to 85 percent less than their branded drug counterpart. Why is the branded medication so much more expensive?
Branded drugs are much more expensive due to the cost of research, clinical trials, and difficulty in the marketing field because the branded drug is unknown to health professionals and the general public. For these reasons, drug manufacturers are granted patent protection for a limited time period to compensate for said reasons and to continue to encourage new drug manufacturing.
When can drug manufacturers begin producing the generic version of a branded drug?
Once the patent for the branded drug expires.
Why do some people experience an adverse effect when switching from brand to generic?
Although the FDA requires the active ingredient in the generic drug to be identical to the branded drug; the inactive ingredients within the medication do not have to be the same. This is why some people may have a reaction when switching due to one of the inactive ingredients contained within the generic drug not being in the original branded drug.
If generic drugs aren’t 100 % identical to branded drugs due to inactive ingredient variations, does it not have the same level of effectiveness as the branded drug?
Research and clinical studies have shown that the efficacy of both a generic drug and branded drug is identical, and that the branded drug is not superior in this context.
