Ampoule labelling.

Bar coding for the medication administration step of the drug-use process is discussed. FDA will propose a rule in 2003 that would require bar-code labels on all human drugs and biologicals. Even with an FDA mandate, manufacturer procrastination and possible shifts in product availability are likely to slow progress. Such delays should not preclude health systems from adopting bar-code-enabled point-of-care (BPOC) systems to achieve gains in patient safety. Bar-code technology is a replacement for traditional keyboard data entry. The elements of bar coding are content, which determines the meaning; data format, which refers to the embedded data and symbology, which describes the "font" in which the machine-readable code is written. For a BPOC system to deliver an acceptable level of patient protection, the hospital must first establish reliable processes for a patient identification band, caregiver badge, and medication bar coding. Medications can have either drug-specific or patient-specific bar codes. Both varieties result in the desired code that supports patient's five rights of drug administration. When medications are not available from the manufacturer in immediate-container bar-coded packaging, other means of applying the bar code must be devised, including the use of repackaging equipment, overwrapping, manual bar coding, and outsourcing. Virtually all medications should be bar coded, the bar code on the label should be easily readable, and appropriate policies, procedures, and checks should be in place. Bar coding has the potential to be not only cost-effective but to produce a return on investment. By bar coding patient identification tags, caregiver badges, and immediate-container medications, health systems can substantially increase patient safety during medication administration.

Drug Labeling↗

PubMed2003

Echinacea and truth in labeling.

BACKGROUND: Echinacea sales represent 10% of the dietary supplement market in the United States, but there is no guarantee as to the content, quality, variability, or contamination in Echinacea preparations. OBJECTIVE: To qualitatively and quantitatively assess the contents of Echinacea-only preparations available in a retail setting. METHODS: One of each single-herb Echinacea preparations that were available in August 2000 was obtained from several stores in the Denver, Colo, area. Thin-layer chromatography (TLC) was used to determine species and measure quantity. From this information, accuracy of species labeling and comparison of constituent to labeled content were assessed. The samples were stratified by whether they were labeled as standardized, and the standardized and nonstandardized samples were compared by ratio of constituent to labeled content. RESULTS: Of the samples, 6 (10%) of 59 preparations contained no measurable Echinacea. The assayed species content was consistent with labeled content in 31 (52%) of the samples. Of the 21 standardized preparations, 9 (43%) met the quality standard described on the label. Labeled milligrams were weakly associated with measured constituent (r = 0.35; P =.02). CONCLUSIONS: Echinacea from retail stores often does not contain the labeled species. A claim of "standardization" does not mean the preparation is accurately labeled, nor does it indicate less variability in concentration of constituents of the herb.

Drug Labeling↗