Drug Name Confusion: Preventing Medication Errors (cont.)
"Global companies want a name to be a worldwide mark," says Doug Kapp, vice president of brand strategy at RTi-DFD, a market research company in Stamford, Conn. In helping pharmaceutical companies set their products apart from others, Kapp says his company recognizes that the name must resonate with the market target and also must pass worldwide trademark requirements.
That recognition, he says, drove his company to develop "relational asemantics," a name-generation process that assists physicians in identifying the nature of a drug. Just as the erectile dysfunction drug Viagra might suggest vitality and vigor, two of RTi-DFD's successes include Advair, linked to "advantage air for asthma," and Amerge, named for "emerging from the pain of a migraine." Kapp says that regardless of how good a name seems, it must be reviewed for potential confusion with other drugs so that "any other associations would not harm the patient in the event of an error."
Satisfying the FDA
Every drug usually has three names: chemical, generic (non-proprietary), and brand (proprietary), and each is subject to different rules and regulations. The chemical name specifies the chemical structure of the drug. It is not preapproved by any organization, nor is it recognized in any standard manuals, such as USP publications. Therefore, chemical names are primarily used by researchers, but not in medical practice.
The FDA requires that either the established, or official, name or in the absence of an official name, the common or usual name, appears on labels and labeling of a drug product. The common name, loosely referred to as the generic name, must accompany the brand name, if there is one. The established name for a drug substance is usually found in the originating country's pharmacopeia, an official book or list of drugs and medicines and the standards established for their production, dispensation, and use.
The generic name is usually created for drug substances when a new drug is ready for marketing. It is selected by the United States Adopted Names (USAN) Council, whose expertise is recognized by the FDA, according to principles developed to ensure safety, consistency, and logic. These names are typically used by health care professionals.
Generic names are coined using an established stem, or group of letters, that represents a specific drug class. For example, the USAN stems include suffixes like -mab for monoclonal antibodies, such as infliximab, or prefixes like dopa- for dopamine receptor agonists. The arthritis medications celecoxib, valdecoxib, and rofecoxib are generic names containing the -coxib stem. Each belongs to a class of drugs known as the COX-2 inhibitors.