Abstract
Recent observational studies of medication errors in community pharmacies suggest that ‘wrong drug’ errors, which occur when a patient receives a drug other than the one prescribed, may occur as many as 3.9 million times per year in the US. Similarity between drug product attributes, especially similarity between drug names, is thought to be a contributing cause of these errors. The challenge facing drug companies is to design new drug names that will not be confused with existing names. In this paper, we attempt to lay out a systematic approach to the design of safe drug names by characterising the process of design as a multiple-objective optimisation problem. We then identify and define the most important constraints (both technical and legal/regulatory) and objectives (such as meaning, memorability, and pronouncability) that a drug name must satisfy and critique methods for evaluating a given name with respect to each safety objective and constraint.
There are a variety of preapproval tests that can be done on a name to test its vulnerability to confusion. These include computerised searches for existing similar names or products, soliciting expert judgements, doing traditional psycholinguistic tests on memory and perception and observing error rates during simulated ordering, dispensing and administration tasks. A different set of strategies is needed to prevent confusion between similar names that are already in use. Preventing confusion between already marketed products typically involves collecting voluntary reports of names involved in confusion errors, posting warnings and alerts both electronically and in areas where drugs are used, including the indication on the prescription, storing confusing drugs in different locations, improving lighting, providing magnifiers, removing one of the confusing drugs from the system or insisting on double-checking for products thought to be vulnerable to confusion.
Finally, since no single design will be optimal with respect to all of the objectives, we describe several approaches to selecting one design from a set of competing alternatives. The pharmaceutical industry and the US FDA have taken important steps recently to improve the preapproval screening of new drug names, but a great deal of research still needs to be done to establish a valid scientific basis for these decisions.
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Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
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Acknowledgements
We have benefited from discussing this topic with Jim Battles, Ken-Yu Chang, Mike Cohen, Bonnie Dorr, William Fisher, Tony Grasha, Bob Lee, Paul Luce, Jerry Phillips, Susan Proulx, Gordon Schiff, John Senders, Richard Shangraw, David Tcheng and Maury Tepper, as well as the speakers at the 26 June 2003, 20–21 October 2003 and 4 December 2003 meetings on minimising drug name confusion, which were sponsored by Health Canada, the US FDA, the Institute for Safe Medication Practices, The Pharmaceutical Research and Manufacturers of America (PhRMA) and other interested parties.
This paper grew out of presentations made at the aforementioned meetings and at the 2nd US/UK Patient Safety Research Methodology Workshop, Safety by Design, which was held on 23-24 September 2003 in Rockville, MD, USA and was sponsored by the Agency for Healthcare Research and Quality (AHRQ) in the USA and the National Patient Safety Research Agency in the UK.
This project was supported in part by the AHRQ grant 1 R01 HS011609-01A2.
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Lambert, B.L., Lin, SJ. & Tan, H. Designing Safe Drug Names. Drug-Safety 28, 495–512 (2005). https://doi.org/10.2165/00002018-200528060-00003
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DOI: https://doi.org/10.2165/00002018-200528060-00003