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  1. Medication Errors Related to CDER-Regulated Drug Products

Update on Phonetic and Orthographic Computer Analysis Tool

In conducting proprietary name reviews, the Division of Medication Error Prevention and Analysis (DMEPA) evaluates the orthographic and phonetic similarity of a proposed proprietary name to other proprietary or established names using the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names that are phonetically and/or orthographically similar to one another. POCA uses algorithms to assess the similarity of names when spoken or written and assigns a percent similarity score to a given name pair.

Version History

The orthographic component of the algorithm in POCA 3.2 was revised and deployed as POCA 4.0 to better capture the shift in the type of errors that are being reported due to the use of electronic prescribing. The algorithm was revised to put more emphasis on the similarity that occurs at the beginning of the name, especially the first three letters and on exact letter matches, and also to emphasize where names share letters that are not consecutive.  POCA 4.2 was also updated to include the ‘Suffixes in proper name of biological products’ to allow external users to search for look-alike/sound-alike suffixes in the proper names of biologic products.

The deployment of POCA 4.3 introduces a new datasource, ‘United States Adopted Name (USAN) Stem’ which provides the ability to identify the presence of USAN stems within proprietary names.  The results of the USAN stem search appear as an additional tab at the top of the results page which can be opened to see if any USAN stems were identified.  This functionality will help external users screen names for the presence of USAN stems automatically.

The POCA search results will continue to provide three data sets: combined orthographic and phonetic matches, phonetic matches, and orthographic matches. In conducting proprietary name reviews, DMEPA continues to evaluate the combined orthographic and phonetic matches based on the validation work done on the revised POCA algorithm. However, to accommodate for the increased sensitivity of the revised algorithm, FDA has revised the percentages associated with the low similarity and moderately similar categories described in our Guidance for Industry, Best Practices in Developing Proprietary Names for Drugs*. The combined orthographic and phonetic matches should now be grouped into one of the following three categories:

  • Highly Similar Pair: combined match percentage score ≥70%
  • Moderately Similar Pair: combined match percentage score ≥55% (previously ≥50%) to ≤ 69%
  • Low Similarity: combined match percentage score ≤54% (previously ≤49%)

*Guidance for Industry, Best Practices in Developing Proprietary Names for Drugs

For more information on POCA 4.3 or to download POCA 4.3, see the POCA 4.3 Homepage