. "6 Action Agenda for the Pharmaceutical, Medical Device, and Health Information Technology Industries ." Preventing Medication Errors: Quality Chasm Series. Washington, DC: The National Academies Press, 2007.
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Preventing Medication Errors
Because generic names are assigned from a limited list of word stems, there are a limited number of ways to represent a drug, increasing the likelihood that a name similar to that of another drug will be selected. Analysis is usually based on peer review. In contrast, brand names are cleared and trademarked4 through the U.S. Patent and Trademark Office. In addition, brand names are analyzed by pharmaceutical companies themselves and the FDA (after submission of a regulatory approval application) using failure modes and effects analysis (FMEA). FMEA is a systematic approach used to identify and prevent product and process problems before they occur (IOM, 2004). With FMEA, a topic (e.g., drug name) is analyzed using a flow diagram of each step involved in the processes and subprocesses affecting the end user (e.g., using the drug in the clinical setting). A failure analysis is conducted to identify all possible points (i.e., modes) and causes of an error, and the severity and probability of each error. The final evaluation determines which modes to eliminate, control, or accept, and actions that can be taken to eliminate or reduce the error. If the company decides that the benefit/risk of the drug name is acceptable, it obtains a trademark for that name and includes the name in its application for regulatory approval.
From that point, the FDA’s Division of Medication Errors and Technical Support (DMETS) reviews brand names for prescription and certain OTC drugs to determine the potential for naming-related medication errors (FDA, 2005b).5 The FDA’s FMEA review includes several evaluations. First, FDA staff undertake a handwriting and verbal analysis (through internal testing) to determine the degree of confusion in visual appearance or pronunciation between the brand name and the names of other products on the market. Second, the FDA uses a computer software tool, the Phonetic Orthographic Computer Analysis (POCA) program, to identify names with similar spelling, letter strings, or syllables. Third, additional risk information (e.g., overlapping strengths, dosage forms, dosing recommendations, indications for use) and container labeling/packaging are evaluated (but not using FMEA) to identify areas of potential confusion and improvement (FDA, 2005a). When errors occur after approval, DMETS has limited ability to require manufacturers to make name or labeling changes.
Generally, FMEA is not used by either pharmaceutical companies or the FDA to evaluate external labeling and packaging. As a result, many of the problems listed in Box 6-2 (e.g., cluttered labeling, small font, serif
The U.S. Patent and Trademark Office examines the similarity between new and existing trademarks in terms of appearance to avoid infringing on an established trademark (Berman, 2004).
Brand names for OTCs are analyzed only for a drug that is a prescription-to-OTC switch for which an NDA exists, or for an NDA or Abbreviated New Drug Application (ANDA). The brand names of monograph drugs do not undergo FMEA analysis.