Chemical Name

The chemical name specifies the molecular structure of the drug and is used primarily by researchers. A drug's chemical name is long and usually difficult to pronounce and remember; consumers, physicians, and pharmacists are therefore better served by referring to the drug's generic name. Michael Cohen, MS, FASHP, RPh, asserts, "The chemical name should never be used in practice, unless it becomes the established or used name, [such as] sodium chloride." Cohen believes that the reasons are simple: Chemical names are not given in any of the standard manuals, such as the Physicians' Desk Reference, publications of the United States Pharmacopeia (USP), or available software and thus cannot be verified. Cohen, cofounder and president of the Institute for Safe Medication Practices (ISMP), a nonprofit organization that educates and alerts health care professionals to drug-use errors, pointed out a more serious concern involving the use of the chemical name. "Chemical names sometimes have numbers in them, such as 6-thioguanine, and any time a drug has a number associated with it, there's a concern that it'll work its way into the prescription." Cohen noted that the "6" in the chemical named might be mistaken for "6 doses."

Generic Name

The generic name is commonly used by health care professionals and is usually created when a new drug is ready to be marketed. Although the manufacturer or sponsor of the drug has the exclusive right of manufacture during the 17 years of the drug's patent, it never owns the generic name. The manufacturer or sponsor of the drug usually initiates the request for a generic name, but the generic name is always in the public domain. Once the drug's patent expires, other manufacturers may make the drug, referring to it by its generic name. In the United States, the generic name must first be approved by the U.S. Adopted Name (USAN) Council and then by the World Health Organization (WHO).

The USAN Council was begun in 1961 and is responsible for creating and assigning a serviceable, generic name to the drug. The Council is made up of three sponsoring organizations: the American Medical Association, the USP, and the American Pharmaceutical Association. A liaison for the U.S. Food and Drug Administration (FDA) is also on the Council. Before being approved by the Council, the generic name must be screened to ensure that it does not look or sound too similar to any other generic or brand name and must also be considered appropriate for the specific drug. After approving the generic name, the Council submits the name to WHO, which has final approval. The name is published in the Trademark Bulletin of the Pharmaceutical Research and Manufacturers of America and in Pharmacopeial Forum, a USP publication, to allow comments or protests. If there are no objections, the name is considered final. After being approved by WHO, the drug is assigned an international nonproprietary name.

The USAN Council adheres to a list of established guidelines in name selection. The most important criterion considered when issuing a generic name is the usefulness of that name to health care providers. Usefulness is defined by suitability in routine use, such as prescribing, dispensing, and administering; for education, such as use by students in the health care professions and by scientific and medical journals; and for international use.

Usefulness also includes simplicity: The name should be short, easy to pronounce, and euphonic. The USAN Council will not approve a generic name that is too similar to other generic or brand names. The name cannot be misleading or confusing; prefixes implying a general descriptive adjective, such as new or improved, would not be accepted, nor would prefixes suggesting the manufacturer's name or an anatomical designation. A stem, or a word common to members of a related group of drugs, is included so that shared characteristics (such as pharmacologic action) can be identified. For example, asthma drugs commonly have an ast stem. The Council uses many other specific guidelines; such guidelines include rules for preferred spelling, use of isolated letters and numbers and hyphenation, and rules for drugs that contain radioactive atoms.

Federal law mandates the use of generic names in advertising and on labels and brochures. According to Cohen, the generic name is essential to pharmacists and other health care professionals, primarily because of the stem. Because of the USAN Council's systematic approach to developing a generic name, pharmacists "can often tell you the chemical composition of it and what its indications and adverse reactions are. If a drug ends with pril they know it belongs to the class called ACE [angiotensin-converting enzyme] inhibitors."

Common examples of USAN Council-approved stems that have established chemical and/or pharmacologic uses (from the USP Dictionary of USAN and International Drug Names) are listed in Table 1.

Brand Name

Although the generic name is in the public domain, the brand name is owned solely by the manufacturer and can be created as soon as the generic name has been approved. Unlike generic names, which are created by the manufacturer in conjunction with the USAN Council, choice of the brand name is motivated by marketing considerations. "Trademark is chosen by the company that wants to market the product, and it's very much like you name a car or any other product-it's a marketing decision," explained Pamela May, attorney for SmithKline Beecham. However, the FDA must approve the name. Although the USAN Council is actively involved in name selection, the FDA has authority over drug labeling and is essentially responsible for approving or disapproving the name of the drug. If the USAN Council receives a submission for a name it considers inappropriate, the Council will suggest another name; but if the FDA disapproves of the name, the manufacturer must create a new one.

The FDA's involvement does not end there, however. "The FDA must approve every written piece involving a drug from the prescribing information to every word on every ad to the size of the print," May explained. But it is the company's marketing department that decides on the best approach-a name that is easy to spell and that consumers and health care providers will remember.

Companies want their drugs' brand name to be associated with the generic name, but not so closely that consumers confuse them. "A trademark, to serve its purpose, is a source of origin," May commented. "For example, Xerox copies only come from a Xerox copier, which only comes from Xerox. You can't get a Xerox copy from a Canon [copier]." The FDA agrees and tries to avoid excessive similarity between brand and generic names.

Creating a generic name is a science; creating a brand name is more of an art. The USAN Council has exact guidelines for assigning generic names, but the guidelines for assigning brand names outline what a company should not do. For instance, the FDA and the USAN Council discourage the use of stems; one reason is that putting a stem in a brand name may increase its similarity to the generic name. And, although a brand name is not required to indicate the drug's use, it cannot imply a wrong indication. The FDA also forbids use of words that make promises, such as cure or safe. The use of cap or Table for capsule or tablet is also discouraged because other formulations may become available. Like the generic name, a brand name cannot be too similar to generic or other brand names. As long as drug companies adhere to these guidelines, they are essentially free to choose any name for their products.

Alleviating Confusion

Generic names frequently look and sound alike. Therefore, such organizations as the ISMP recommend use of both the generic and the brand names when prescribing such medications. For example, amrinone is an inotropic agent for patients with congestive heart failure and is often used in the intensive care unit (ICU). Another drug, amiodarone, is also used in the ICU in patients with cardiac disease but this drug is an antiarrhythmic agent. Patients have died as a result of confusion between these two drugs. The ISMP has petitioned the USAN Council to change one of the generic names. In the interim, the ISMP recommends that physicians write prescriptions for "Inocor (amrinone)" or "Cordarone (amiodarone)." Cohen believes that writing both the generic and brand names will reduce the number of errors, but that a more advantageous approach would be to avoid using products identified as having problems with name confusion. For example, the ISMP recommends using Primacor (milrinone) instead of amrinone.

Confusion arising from similar-sounding drug names is occasionally unavoidable, despite the stringent USAN Council and FDA naming guidelines. To monitor the situation the USP has a Medication Errors Reporting Program that watches for similar-sounding or look-alike drug names and the FDA has a Medication Errors Committee that monitors reported medication errors and occasionally makes recommendations.

The complex procedure of giving each drug a chemical, generic, and brand name does not always eliminate confusion; however, pharmaceutical companies, the USAN Council, and the FDA, in their respective roles in the complex drug naming process, all share one basic goal: to name a drug so that the least possible confusion results.

-Linda Gundersen