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Generic Substitution
JAMA. 1998;279:645.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has asked health professional organizations for assistance in informing their members of its position on generic substitution. The FDA has been receiving inquiries from state legislatures, state pharmacy boards, and drug utilization review committees as they consider issues related to the substitution of medications characterized as narrow therapeutic index drug products. A particular issue is whether the safety and efficacy profile of these products could change if a switch were made from a brand-name product to an FDA-designated, therapeutically equivalent, generic drug product.
There are products in which small changes in the dose and/or blood concentration could potentially result in clinically important changes in drug efficacy or safety. Usually these drugs require frequent dose adjustments and careful patient monitoring irrespective of whether the drug is a brand or generic drug product. These drugs may sometimes be described in FDA approved drug labeling as narrow therapeutic range drugs.
For . . . [Full Text of this Article]
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