Naming, Labeling, and Packaging of Pharmaceuticals
Naming, Labeling, and Packaging of Pharmaceuticals
The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of privatesector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains.
Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.
Confusing drug names, labels, and packages are important sources of medical errors. Drug names often sound and look alike, labels contain visually confusing information, and packages may be designed for the marketplace rather than for practice conditions. Pharmaceutical companies believe that practitioners are responsible for accurate dispensing and drug delivery. As a result, the current system relies on an assumption of perfection by practitioners to eliminate errors in dispensing.
There are well-known, effective methods for minimizing confusion and making it more difficult to commit medical errors. However, pharmaceutical companies tend to resist implementing these methods because of the complexity, cost, concern about increasing already cumbersome regulations, fear of liability exposure, and loss of competitive advantage. In addition, the various regulatory agencies have only recently begun to consider safety issues. Therefore, some new approach or combination of approaches is required to help us discover and continually define methods for improving safety.
This article is an adaptation of a confidential working paper discussing the problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals that was prepared for the Executive Session on Medical Error and Patient Safety, John F. Kennedy School of Government, Harvard University. The working paper was presented January 22, 1999. The facts presented here are accurate to that date; this article also discusses subsequent regulatory changes. The purpose of the article is to provide background information not readily available in standard sources. Information has been provided by members of the Executive Session and through confidential interviews with representatives of the American Society of Health-System Pharmacists (ASHP), the Food and Drug Administration (FDA), the Institute for Safe Medication Practices (ISMP), the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the U.S. Pharmacopeia (USP).
The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of privatesector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains.
Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.
Confusing drug names, labels, and packages are important sources of medical errors. Drug names often sound and look alike, labels contain visually confusing information, and packages may be designed for the marketplace rather than for practice conditions. Pharmaceutical companies believe that practitioners are responsible for accurate dispensing and drug delivery. As a result, the current system relies on an assumption of perfection by practitioners to eliminate errors in dispensing.
There are well-known, effective methods for minimizing confusion and making it more difficult to commit medical errors. However, pharmaceutical companies tend to resist implementing these methods because of the complexity, cost, concern about increasing already cumbersome regulations, fear of liability exposure, and loss of competitive advantage. In addition, the various regulatory agencies have only recently begun to consider safety issues. Therefore, some new approach or combination of approaches is required to help us discover and continually define methods for improving safety.
This article is an adaptation of a confidential working paper discussing the problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals that was prepared for the Executive Session on Medical Error and Patient Safety, John F. Kennedy School of Government, Harvard University. The working paper was presented January 22, 1999. The facts presented here are accurate to that date; this article also discusses subsequent regulatory changes. The purpose of the article is to provide background information not readily available in standard sources. Information has been provided by members of the Executive Session and through confidential interviews with representatives of the American Society of Health-System Pharmacists (ASHP), the Food and Drug Administration (FDA), the Institute for Safe Medication Practices (ISMP), the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the U.S. Pharmacopeia (USP).
