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# Guidance Helps Sponsors with Proprietary Names
- URL: https://www.fdaweb.com/guidance-helps-sponsors-with-proprietary-names/
- Published: 2016-02-09T12:00:00.000Z
- Updated: 2026-09-15T02:34:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134708

> CDER Division of Medication Error Prevention and Analysis deputy director **Lubna Merchant** says that a draft guidance issued last year is to help drug and biologic product sponsors develop proprietary names that don’t cause or contribute to medication errors or misbrand a drug. Writing in a *From Our Perspective* blog [post](http://www.fda.gov/Drugs/NewsEvents/ucm485317.htm?ref=fdaweb.com), she says that the agency uses a National Coordinating Council for Medication Error Reporting and Prevention definition of medication errors as “any preventable event that may cause or lead to inappropriate medication use or patient harm.” Medication errors can occur, she writes, while the drug is in the control of the healthcare professional, patient, or consumer.  
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> Ways in which drug name confusion can cause medication errors include similarity in spelling and pronunciation, shared strength or dose between products, and confirmation bias when people who are familiar with a drug have a tendency to search for, interpret, or recall information in a way that confirms their beliefs or hypotheses.  
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> Merchant says that FDA recommends that sponsors submit their request for agency review of a proposed proprietary name as soon as they have the recommended supporting information outlined in a guidance on such submissions. She says that in its review, FDA looks for error-prone naming attributes and potential sources for error, including the spelling and pronunciation of the name and its appearance when scripted. The agency also performs prescription simulation studies with staff by asking them to interpret a proposed proprietary name in simulated real-world use conditions. It also evaluates name similarity through its Phonetic and Orthographic Computer Analysis program to identify names that look or sound like the proposed name.  
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> If an error is identified from MedWatch reports, she says, FDA may recommend that the sponsor make changes to the product labeling and packaging. In rare cases, Merchant says, the agency works with sponsors to change a proprietary name to resolve medication errors resulting from name confusion. It also may use drug safety communications, consumer updates, or scientific publications to inform the public about medication errors. And sponsors may conduct outreach to the public about medication errors through mass mailings, e-mails, educating drug representatives, and reaching our directly to pharmacies and wholesalers.  
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> “To help reduce drug name confusion errors,” Merchant concludes, “we encourage healthcare professionals to be aware of drug names that look and sound alike, and identify drug names that may be problematic. Pharmacists and nurses should match the drug’s indication to the patient’s condition before dispensing or administering the product. It is also important for patients to double-check their medications and ask their healthcare provider or pharmacist about medications that look or sound different than expected.”