Healthy Skepticism Library item: 5842

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lambert BL, Lin SJ, Tan H.
Designing safe drug names.
Drug Saf 2005; 28:(6):495-512

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.

Keywords:
Confusion/prevention & control Drug Labeling/methods Drug Labeling/standards Humans Medication Errors/prevention & control Pharmaceutical Preparations* Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S. Terminology*