OTC PRODUCTS
Calling for universal use of barcodes
A pharmacist reported that an over-the-counter (OTC) product purchased by the hospital, oxymetazoline hydrochloride decongestant spray, 0.05%, lacked a barcode and could not be scanned at the bedside (see photo). Instead, nurses had to scan the barcode on the product's carton, which is usually discarded after opening. The hospital purchased another brand of oxymetazoline and found that it also lacked a barcode on the container.
The FDA barcode rule requires certain human drug and biological product labels to have a barcode on the immediate container with, at a minimum, the National Drug Code. However, the rule exempts manufacturers from having to print a barcode on the immediate container of many OTC products. The rule notes that a barcode is required only on the immediate container of OTC drugs that are "dispensed pursuant to an order and are commonly used in hospitals," or that are packaged or labeled for hospital use. Because "commonly used in hospitals" is open to interpretation, manufacturers of OTC drugs used in hospitals may not print a barcode on the immediate container.
The Institute for Safe Medication Practices (ISMP) has contacted the FDA and Major Pharmaceuticals, the product's manufacturer, about the situation. Given that almost any OTC drug may be used in a hospital, ISMP urges all drug manufacturers to comply with the rule, even if not required to do so.
ANTICOAGULANT FORUM
Join a new safety campaign
For more than 28 years, the Anticoagulation (AC) Forum has been educating healthcare professionals and advocating for clinical best practices in the field of anticoagulation therapy. The AC Forum recently released an FDA-funded report, Core Elements of Anticoagulation Stewardship Programs, similar to successful stewardship campaigns involving antibiotics. The anticoagulation stewardship guide outlines ways to improve the safety and quality of patient care and reduce adverse drug events associated with anticoagulants. The guide defines seven core elements for implementing anticoagulation stewardship programs, starting with securing administrative leadership commitment and ending with advancing education, comprehension, and competency. It also includes a checklist for evaluating current practices and a gap analysis that identifies weaknesses in oversight modalities (such as regulations and quality measures) for hospitals and skilled nursing facilities. The guide is available for download at http://www.ismp.org/ext/330. There is no cost to join the AC Forum and all resources are free of charge.
BORTEZOMIB
Take the right route
Bortezomib is a proteasome inhibitor prescribed to treat certain types of cancer. Of the three bortezomib products available on the market, only the product marketed as Velcade is approved for both subcutaneous and I.V. administration. The two FDA-approved generic bortezomib products, which are available from Dr. Reddy's and Fresenius Kabi, are labeled for I.V. administration only. Recently a hospital reported that a pharmacist erroneously dispensed the Fresenius Kabi product for subcutaneous use.
One might assume that the I.V.-only products are identical to Velcade, but they are not. The formulation of the Fresenius Kabi product is different than that of Velcade; whether the Dr. Reddy's product also differs is unclear. However, no bioequivalence studies support subcutaneous administration of either product.
The package labels for the Fresenius Kabi and Dr. Reddy's products state, "For Intravenous Use Only," but fail to note that these products should not be administered subcutaneously. The FDA should work with the two manufacturers to clarify the proper routes of administration in their product labeling. For now, "For Intravenous Use Only" should be emphasized on the labels of the Fresenius Kabi and Dr. Reddy's products with use of red type and a larger font.