A statement of reaffirmation for this policy was published on September 1, 2005.
A statement of reaffirmation for this policy was published on January 1, 2009.
This policy is a revision of the policy posted on February 1, 1976.

POLICY STATEMENT

This Article
Right arrow Full Text (PDF)
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation

Generic Prescribing, Generic Substitution, and Therapeutic Substitution

Committee on Drugs

Pressures generated by a constellation of professional consumer, legislative, and health care provider vider groups in this era of increasing health care costs have led to enactment of generic substitution laws in 50 states. The general acceptance of this concept, despite conflicting evidence that it has reduced the cost of prescription items to the consumer, has led to the concept of therapeutic substitution. Considerable confusion exists among health care professionals regarding the precise meaning of these concepts.

Generic prescribing is the prescribing of a drug by a physician using the generic name. This leaves the choice of brand to the dispensing pharmacist. Generic substitution is a pharmacist-initiated act by which a different brand or an unbranded drug product is dispensed instead of a drug brand that was prescribed by the physician. This means substituting the same chemical entity in the same dosage form for one marketed by a different company. Therapeutic substitution is a pharmacist-initiated act by which a pharmaceutical or therapeutic alternate for the physician-prescribed drug is dispensed without consulting the physician. This denotes replacement of the prescribed drug with a chemically different drug within the same therapeutic category, eg, hydrochlorothiazide for furosemide; ranitidine for cimetidine; chloramphenicol for erythromycin.

In 1976, the AAP Committee on Drugs published a commentary in Pediatrics (1976;57:275-277) on generic prescribing and concluded that "the lack of data on bioavailability and bioequivalence in children precludes blanket support of generic prescribing for infants and children." The Committee recently reviewed this issue and concluded that the situation has changed little during the past decade.


Statements of reaffirmation:

AAP Publications Retired and Reaffirmed
American Academy of Pediatrics
Pediatrics 2005 116: 796. [Extract] [Full Text] [PDF]

AAP Publications Retired and Reaffirmed
Pediatrics 2009 123: 188. [Extract] [Full Text] [PDF]

The following policy statement has been revised:

Generic Prescribing
Sumner J. Yaffe, C. Warren Bierman, Howard M. Cann, Sanford N. Cohen, John Freeman, Benjamin M. Kagan, Ralph Kauffman, Albert Pruitt, Sydney Segal, Lester Soyka, Charles F. Weiss, Gregory Chudzik, John C. Ballin, Pierre S. Del Prato, Alan K. Done, Louis Farchione, Godfrey Oakley, Steven Sawchuk, C. P. Scott, and Artemis P. Simopoulos
Pediatrics 1976 57: 275-277. [Abstract] [PDF]