Abstract
Background
Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which could create confusion among users and challenge the safe use of medicines. The availability of foreign products in local markets aggravates the situation. This study was designed to examine the registered medicine proprietary names in Sri Lanka to discern the presence of similar medicine names in the industry.
Methods
A cross-sectional study was conducted on the registered drug proprietary names in Sri Lanka. Using the RAND and RANK functions in Microsoft® excel® 365, a random sample of 385 proprietary names was selected. Two evaluators independently evaluated each proprietary name in the sample against the other registered proprietary names following a stepwise text filtering method. After each filter, the resulting proprietary names were manually examined for identical, similar-looking, and similar-sounding proprietary names to the name under evaluation. The observations were matched, categorized, and collated into ten groups.
Results
Among the 385 names evaluated, 138 (35.84%) proprietary names had no similarity to existing other registered proprietary names. The rest of the names (n = 247, 64.15%) were found to be either identical (n = 03 pairs), look-alike (n = 91 pairs), or sound-alike (n = 80 pairs) to the registered proprietary names.
Conclusion
The findings revealed the presence of equal and similar proprietary names in the system. A multifactorial strategy led by the National Medicine Regulatory Authority (NMRA) is recommended to minimize the confusing names entering the system. Primarily the NMRA’s call for action should include adequate industry guidance with specific guidelines, a significant pre-submission assessment process, and denying approval of LASA proprietary names.
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Data Availability
Abbreviations
- FDA:
-
Food and Drug Administration
- INN:
-
International nonproprietary names
- ISMP:
-
Institute for Safe Medication Practices
- LA:
-
Look-alike
- LASA:
-
Look-alike sound-alike
- MHRA:
-
Medicines and Healthcare products Regulatory Agency
- NMRA:
-
National medicines regulatory authority
- POCA:
-
Phonetic and Orthographic Computer Analysis
- SA:
-
Sound-alike
- TML:
-
Tall-man lettering
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MJ was the principal investigator. MJ, SS, and SZ designed the study. Label evaluation, analysis, and interpretation were performed by MJ, TLIS, and SS. MJ wrote the manuscript. All authors read and approved the final manuscript.
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Jayasinghe, M., Srilal, T.L.I., Subasinghe, S. et al. Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka. Ther Innov Regul Sci 57, 1248–1259 (2023). https://doi.org/10.1007/s43441-023-00557-7
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DOI: https://doi.org/10.1007/s43441-023-00557-7