Drug Name Confusion: FDA Approval

July 8, 2008

The Problems

Medication errors can occur between brand names, generic names, and brand-to-generic names like Toradol and tramadol. But sometimes, medication errors involve more than just name similarities. Abbreviations, acronyms, dose designations, and other symbols used in medication prescribing also have the potential for causing problems.

For example, the abbreviation “D/C” means both “discharge” and “discontinue.” The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) notes that patients’ medications have been stopped prematurely when D/C–intended to mean discharge–was misinterpreted as discontinue because it was followed by a list of drugs.

Illegible handwriting, unfamiliarity with drug names, newly available products, similar packaging or labeling, and incorrect selection of a similar name from a computerized product list, all compound the problem.

The XYZs of Naming Drugs

Names are part of developing a new drug. And coming up with a catchy, snappy moniker that distinguishes one drug from another isn’t easy. For the most part, drug companies want a name that will boost sales, while consumers long for some indication from the name of what the drug does. The FDA, however, won’t allow names that imply medical claims, suggest a use for which a drug isn’t approved, or promise more than they can deliver.

Naming a drug can be as complicated as creating a rhythmic cacophony of unpronounceable syllables and emphatic-sounding letters, such as C and P. Other naming strategies include letters that when strung together sound like something high-tech–think Zyprexa, Lexapro, and Xanax.

Creating the name of a new drug in a market that already houses more than 22,000 drugs is no easy process. Nor is it cheap!

At a minimum, manufacturers must make certain their proposed drug name passes the worldwide trademark requirements, complies with standards not to imply a medical claim and meets standards for patient safety.

If the FDA rejects a name that a drug company has spent years and possibly millions of dollars creating, it can cost millions more in both lost sales and trashed marketing and sales materials … and then it’s back to the drawing board!

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.
Fixing the Problems

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.

Click here to learn more on Choosing the Right Drug Name: How to Increase Your Chances for Approval