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.
Names that include such stems, chemistry roots, or any other coded information are easier to remember, and give clues about what a drug is used for. These names, however, typically sound or look so much alike that they contribute to medication errors, especially if the products share common dosage forms and other similarities.
The brand name, also called trademark, can be created as soon as a generic name has been established. Only brand names of products subject to a new drug application or an abbreviated new drug application must be approved by the FDA first. This requirement distinguishes them from generic names.
According to a report in the January-February 2004 issue of the Journal of the American Pharmacists Association, there are more than 9,000 generic drug names and 33,000 trademarked brand names in use in the United States.
To minimize confusion between drug names that look or sound alike, the FDA reviews about 400 brand names a year before they are marketed. About one-third are rejected. The last time the FDA changed a drug name after it was approved was in 2005, when the diabetes drug Amaryl was being confused with the Alzheimer's medication Reminyl, and one person died. Now the Alzheimer's medicine is called Razadyne.
Generic name confusion also has led to regulatory action, as well as to pharmacy practice recommendations. For example, the USP and the USAN changed the drug name "amrinone" to "inamrinone" after receiving reports of serious outcomes from medication errors involving the similar name pair "amrinone/amiodarone." The generic drug industry also has responded to requests from the FDA to use a mixture of uppercase and lowercase letters to highlight differences in similar generic names, such as vinBLAStine and vinCRIStine. This step also encouraged manufacturers to supplement their new drug applications with revised labels and labeling that visually differentiated their generic names with the so-called "tall man" letters. And the NCCMERP recommendations encourage doctors to write both brand and generic names on prescriptions.
A number of other efforts are under way to reduce the incidence of medical errors stemming from similar-looking or similar-sounding names. The FDA, for example, is encouraging people to talk with their physicians to ensure that they have a complete understanding about their prescription before leaving the doctor's office, and to verify the information with the pharmacist before the medication is dispensed.