GPI Codes - Generic Product Identifiers

Wolters Kluwer Clinical Drug Information's Generic Product Identifier (GPI) defines pharmaceutically equivalent drug products that are identical in terms of:

• active ingredient(s)
• route of administration
• dosage form
• strength or concentration
• therapeutic use

Clinical considerations may also enter into the GPI assignment. The GPI does not consider the following:

• manufacturing process
• patent or intellectual property rights
• differences in bioequivalence or therapeutic equivalence
• inactive ingredients
• legal restrictions for substitution

The GPI categorizes drug products by a hierarchical therapeutic classification scheme for use in the following:

• formulary management
• market research
• various reporting applications

The unique and proprietary therapeutic basis of this system is more useful than conventional pharmacological approaches to drug classification. This coding system is based on subsets contained in the GPI structure. Drug product records containing a GPI may be readily manipulated to categorize drug products at various levels of specificity.

A common application and use of Wolters Kluwer Clinical Drug Information's data is the identification of generic and therapeutic equivalents. Different markets and applications have different definitions of a generic drug product. The GPI is considered a starting point for selecting generic drug products and must be used in conjunction with other data elements for drug product identification. An example is the FDA's Orange Book Therapeutic Equivalence Evaluation Code (refer to the section entitled "Generic Substitution Versus Therapeutic Alternate Identification").

Note Drug products identified as "pharmaceutical equivalents" are not necessarily bioequivalent or therapeutically equivalent. Differences in bioequivalence and legal restrictions concerning drug product substitution may result from brand interchange or drug product substitution. Dosage forms considered within the GPI hierarchy are based on Wolters Kluwer Clinical Drug Information's proprietary dosage form concept.

In assigning the GPI, Wolters Kluwer Clinical Drug Information considers the therapeutic use of the drug. In some instances, drugs may be classified in a common therapeutic area for ease of identification and selection.

Wolters Kluwer Clinical Drug Information's Therapeutic Classification System (TCS)

The first 10 characters of the GPI identify the drug product according to Wolters Kluwer Clinical Drug Information's Therapeutic Classification System (TCS).

GPI Structure

The 14-character GPI consists of seven subsets, each providing increasingly more specific information about drug products. Asterisks included in the drug product name refer to the position of the product within Wolters Kluwer Clinical Drug Information's TCS. The asterisk before the name indicates the location is within the first three Record Types; the asterisk(s) after the name indicates the level of specificity. These subsets are structured and identified below: