Formulation Substitution (or Therapeutic Equivalency)
Definition: As patients and prescription benefit plans seek to lower their healthcare costs, they may substitute a less expensive therapeutically equivalent drug for a more costly drug.
Formulation substitution can include switching from a brand-name drug to a generic drug, switching from one generic drug to another generic drug, or (rather uncommonly) switching from a generic drug to a brand-name drug.
In most states, formulation substitution is allowed and encouraged, provided that the replacement formulation is deemed to be "therapeutically equivalent" to the innovator formulation by the Food and Drug Administration (FDA).
The FDA publishes a list of drug products and equivalents entitled Approved Drug Products with Therapeutic Equivalence Evaluations; this is commonly referred to as the Orange Book.
The FDA's designation of "therapeutic equivalence" indicates that the generic formulation is bioequivalent to the innovator formulation.
This means that drug products are considered to be therapeutic equivalents only if they have identical active ingredients and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
Generic Drug (or Generic Equivalent)
Definition: A drug which is exactly the same as a brand name drug and which may be manufactured and marketed after the brand name drug's patent expires (approximately 9-10 years after the brand-name drug entered the market).
Generic drugs cost significantly less than brand name drugs, and are identical in terms of efficacy, safety, side effect profile, and dosing.
Important exceptions to this may include drugs such as immunosuppressants or drugs with a "narrow therapeutic index" such as anti-arrhythmics.
"Narrow therapeutic index" refers to drugs that have a high rate of side effects at commonly administered dosages.
WITH LEROY JONES, JR."
September 30, 2009
TOPIC: "NEW SHOW - PARTICIPATORY HEALTH: ONLINE AND MOBILE TOOLS"
With Jane Sarasohn-Kahn, the author of Participatory Health: Online and Mobile Tools Help Chronically Ill Manage Their Care
Prepared for the California HealthCare Foundation
More information on this
issue @ Talking Technology with
NEW SHOW - PEW RESEARCH CENTER (with Susannah Fox, the Associate Director of the Pew Internet & American Life Project)
NEW SHOW - SENSEI (with Dr. Robert Schwarzberg - President & CEO of Sensei, Inc.)