It is estimated that between 6.2% and 14.7% of all medication error events are due to look-alike or sound-alike (LASA) medication names, according to an abstract published on the British Journal of Clinical Pharmacology1. The Institute of Medicine (IOM) has recommended since 1999 that the Food and Drug Administration (FDA) encourage pharmaceutical companies to test proposed proprietary names to reduce these incidences. In addition to recommendations published by the FDA, there are three key steps biopharma companies can take to prioritize safety and medication error prevention when creating and choosing a proprietary (trade) name.
Know the risk
Having a thorough understanding of the results from an FDA Phonetic and Orthographic Computer Analysis (POCA) is critical. POCA is an automated method of analyzing Phonetic and Orthographic similarities between a candidate name and names in a variety of databases. The analysis uses drug products from a variety of data sources and assigns a combined score from 1 to 100 as well as a score for the pronunciation (phonetic) and spelling (orthographic). This calculated score is important because high levels of similarity in these areas indicate possible confusion with other names on the market.
For example, a score of 70 or greater for the combined, orthographic, or phonetic categories may trigger a closer evaluation by authorities and could lead to name denial.
Product characteristics may increase or mitigate the risks of two LASA names. Many drugs come as an oral tablet or capsule with a dose and frequency of once daily. In this case, the two products with phonetically or orthographically similar names have a much higher chance of contributing to a medication error. However, products that vary in strength, dose, frequency, route of administration, packaging, and administration setting may provide enough differentiation to have the names safely coexist in the same space.
An example of this might be a single-strength injectable given once daily only in a hospital setting, versus a multiple-strength oral tablet given twice daily in a bottle of 60 tablets. In this instance, doing a risk assessment of the name pair, including their POCA score and product characteristics, can give a better picture of risk and potential for error.
A prescription (Rx) study and focus group moves past a computer analysis and uses healthcare practitioners to analyze the proposed proprietary name, providing real-world data. These studies typically include handwritten samples for an inpatient medication order, an outpatient prescription, and a voice-recorded prescription. They are then sent to a focus group of healthcare practitioners to provide their interpretation of the name and whether they think the name looks or sounds like other names currently on the market. These studies provide a real-world glimpse into how the name will be interpreted when used in practice.
These key steps may help determine whether a product can safely coexist in the current market. Understanding this information about a proposed proprietary name and how it might contribute to a medication error will help determine the chances of regulatory authorities ultimately allowing the proposed proprietary name to be approved.
Max Straka is the Director, Drug Safety, at Leaderboard Branding, a Fingerpaint company. He previously served as a U.S. Food and Drug Administration (FDA) Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. He may be reached at email@example.com.