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混淆药品商品名的识别:斯里兰卡安全用药的一项横断面研究。

Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use-A Cross-Sectional Study in Sri Lanka.

机构信息

Department of Pharmacy, Faculty of Allied Health Sciences, University of Ruhuna, Karapitiya, Galle, 80000, Sri Lanka.

National Medicines Regulatory Authority, Colombo, Sri Lanka.

出版信息

Ther Innov Regul Sci. 2023 Nov;57(6):1248-1259. doi: 10.1007/s43441-023-00557-7. Epub 2023 Aug 17.

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.

摘要

背景

形似音似(LASA)药物具有相似的发音(语音)和/或表现形式(拼写),这可能会使用户感到困惑,并对药物的安全使用构成挑战。当地市场上的外国产品的供应使情况更加恶化。本研究旨在检查斯里兰卡注册药品的商品名,以发现行业中是否存在类似的药品名称。

方法

对斯里兰卡注册药品的商品名进行了横断面研究。使用 Microsoft® excel® 365 中的 RAND 和 RANK 函数,随机选择了 385 个商品名的样本。两名评估员按照逐步文本过滤方法,独立评估样本中每个商品名与其他已注册商品名的相似性。在每个过滤器之后,将生成的商品名手动检查与正在评估的名称相同、相似外观和相似发音的商品名。观察结果进行匹配、分类和整理为十个组。

结果

在所评估的 385 个名称中,有 138 个(35.84%)商品名与现有其他已注册商品名没有相似之处。其余名称(n=247,64.15%)被发现与已注册的商品名相同(n=03 对)、形似(n=91 对)或音似(n=80 对)。

结论

研究结果表明,系统中存在相同和相似的商品名。建议由国家药品监管局(NMRA)领导的多因素策略,以尽量减少进入系统的混淆名称。NMRA 的首要行动呼吁应包括为行业提供充分的指导,制定具体的准则,进行重大的预提交评估程序,并拒绝批准形似音似的商品名。

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