A variety of drugs, including both innovative medicines and generics, are being discovered actively. The nomenclature of these drugs is a complex task. The drugs are named as per the schemes in which the specific syllable in the drug name conveys information about the drug’s chemical structure, pharmaceutical action, or indication. Drug names also include a unique, memorable, and acceptable prefix by the sponsoring firms.
Despite having a unique name for every medicine, sometimes two (02) or more medicines may have orthographic and phonetic similarities. This can cause confusion in the initial phases, but later it can cause severe repercussions.
The POCA was introduced to avoid this level of perplexity and risk of error. POCA stands for Phonetic and Orthographic Computer Analysis. It is a software tool that uses an advanced algorithm to determine the orthographic and phonetic similarity between two (02) drug names. It was first brought into action in 2009 by the FDA.
The Agência Nacional de Vigilância Sanitária (ANVISA) adopted the POCA program in 2018. This program analyzes orthographic and phonetic similarities that a brand has with medicines already registered in the country. This program can compare a drug’s name against multiple drug names found in several data sources. The POCA’s Brazilian database is updated in accordance with the name of the drugs already registered with the ANVISA.
The POCA search provides three (03) sets of data:
- Combined orthographic and phonetic matches
- Phonetic matches
- Orthographic matches
Based on the combined scores of the POCA, similar names are classified as:
|
Name pair categories |
Combined score |
|
High similarity name pair |
≥70% |
|
Average similarity name pair |
≥55% to ≤ 69% |
|
Low similarity name pair |
≤54% |
In the case of high similarity name pair, the risk of error is highest even if there are differences in the product profile. The same strength and dose of drugs are likely to potentiate the risk for name confusion in moderately similar names.
ANVISA has the authority to reject a name if it is confusing or misleading at any point in time. Therefore, to avoid ANVISA rejections, it is better to do a prior POCA analysis.
In addition to POCA, the ANVISA recommends performing simulation studies to evaluate the ability of consumers and health professionals to understand a medicine name.
The POCA is a useful tool to avoid confusion among phonetically similar drug brand names. It is also available online for fast and direct access without the need to download the software.
This is indeed an age of digitization for the pharmaceutical market. Right from using technology for a drug’s nomenclature to online submissions of dossiers, everything is just a click away! In such a dynamic scenario, a proper understanding and experience in the market is a must.
Our Regulatory experts at Freyr help Life Sciences companies in making well-thought-out market strategies and streamlined submissions. Be it end-to-end Regulatory support or gap analysis, or even compilation and submission of dossiers, Freyr is your one-stop solution for all your Regulatory needs.
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