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buffsthestuff said:The crimped on cap reads "warning: paralyzing agent" whats the deal with that I just emailed the guy but i've never seen this before
REGULATORY FOCUS
Warning: Keep off the Caps
USP wants to see only cautionary statements on the caps of injectable products.
Daphne Allen
In an effort to reduce medication errors, the United States Pharmacopeia (USP) has proposed revisions to General Chapter <1>, “Injections,” that will restrict the printing on caps and ferrules of all injectable drug products to cautionary statements only. General Chapter <1> covers in-jectable drug packaging and labeling.
USP announced the proposed revisions, which would become official October 1, 2005, in its May/June 2003 Pharmacopeial Forum (PF). The move was based upon a 1997 recommendation from the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP). According to NCCMERP’s Web site, if such a restriction were implemented, it could “help to reduce errors in which product labeling and package design have been identified as contributing factors.” At the time, NCCMERP also recommended that IV drug names be visible on both sides of a container, and drug names be printed at least as large as company names and logos.
USP agrees with NCCMERP’s view on cap printing. “USP expert committees involved in this decision believe that limiting the print on these drug products will help to ensure that cautionary messages will immediately be recognized to help prevent life-threatening medication errors,” said Diane D. Cousins, vice president of USP’s Center for the Advancement of Patient Safety. “However, to minimize the impact on industry, the plan is to delay implementation of the change to allow organizations time to comment.”
In 1999, USP’s PF ran the article “Status of Proposal to Restrict Printing on Vial Caps and Ferrules and to Require Color Coding of Closure Systems for Neuromuscular Blockers.” Since then experts have considered the pros and cons of such labeling restrictions. After public comments received during the past year were reviewed, proposed changes to the General Chapter were made through a collaboration of USP’s expert committees on parenteral products—industrial, nomenclature and labeling, anesthesiology, and safe medication use.
USP is also proposing that injectable preparations of neuromuscular blocking agents (NMBAs) bear a cautionary statement on the ferrules and cap overseals. NMBAs, often called paralyzing agents, produce skeletal muscle paralysis when an artificial breathing apparatus is used, particularly during surgical procedures. Caps and ferrules of these products would have to bear the words, Warning: Paralyzing Agent or Paralyzing Agent in black or white print for contrast. Once official, this requirement would mark the second time a warning has become mandatory. A current pharmacopeial standard requires the warning statement Must Be Diluted on caps and ferrules of potassium chloride for injection concentrates.
Comments on the proposed revisions to General Chapter <1> “Injections” should be addressed to James W. Kelly at USP, 12601 Twinbrook Parkway, Rockville, MD 20852. Additional questions pertaining to injections can be e-mailed to media [email protected].
Copyright ©2003 Pharmaceutical & Medical Packaging News
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