Naming, labeling, and packaging of pharmaceuticals

The problem of medical errors associated with the naming, labeling, and pac kaging of pharmaceuticals is discussed. Sound-alike and took-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient inju ry or death. The existing medication-use system is flawed because its safet y depends on human perfection. Simplicity, standardization, differentiation , lack of duplication, and unambiguous communication are human factors conc epts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, curre nt methods are based on long-standing commercial considerations and bureauc ratic procedures. The process for naming a marketable drug is lengthy and c omplex and involves submission of a new chemical entity and patent applicat ion, generic naming, brand naming, FDA review, and final approval. Drug com panies seek the fastest possible approval and may believe that the incremen tal benefit of human factors evaluation is small. "Trade dress" is the conc ept that underlies labeling and packaging issues for the drug industry. Dru g companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem r emains. Drug names, labels, and packages are not selected and designed in accordanc e with human factors principles. FDA standards do not require application o f these principles, the drug industry has struggled with change, and privat e-sector initiatives have had only limited success.