STANDARDIZED CLINICAL DRUG NOMENCLATURE

To encourage federal agencies, the pharmaceutical industry, pharmacy and medical software providers, and purveyors of clinical data repositories and drug databases to explore the potential benefits of supplementing or modifying the National Drug Code with a coding system that can be used effectively to support patient care, research, and financial management; further,

To encourage that such a coding system encompass prescription drug products, nonprescription medications, and dietary supplements and include both active and inactive ingredients.

Rationale

Clinical decision support systems (CDSS) in computerized provider order entry (CPOE) and pharmacy information systems have been widely used for screening drug interactions and patient allergies. For this screening to be effective, a baseline coding structure for medications must be available, and the coding system needs to include prescription and nonprescription medications, dietary supplements, and drug excipients.

The National Committee on Vital and Health Statistics (NCVHS) has recommended regulatory changes to give the Food and Drug Administration (FDA) full control over the National Drug Code (NDC). Currently, FDA controls only a portion, and manufacturers control the remainder. FDA has made recommendations for uniform standards to enable electronic prescribing (e-prescribing) in ambulatory care. During the past several years, NCVHS has focused considerable attention on the feasibility and desirability of standards to support e-prescribing and the need for standard terminology for clinical drugs to facilitate automated drug-use review and decision support for patient safety. In previous reports, NCVHS documented NDC shortcomings, most notably concern about perceived weaknesses of the current NDC database and linkage of the NDC to RxNorm concepts. NCVHS expressed the need for harmonization of terminologies to eliminate incompatibilities that impair drug utilization studies and may negatively affect patient safety. RxNorm, a standardized nomenclature for clinical drugs, is produced by the National Library of Medicine. In RxNorm, the name of a clinical drug combines its ingredients, strengths, and form. RxNorm has limitations, however; it does not identify a product’s excipients or include herbal products or nonprescription medications.