According to recent news that our Washington D.C. pharmacy error injury attorneys have been following, the U.S. Food and Drug Administration (FDA) has committed to reduce medication mistakes by publishing a draft guidance by the end of this fiscal year. The FDA states that one third of medication errors, including 30% of errors ending in deaths that are reported to the Institute of Safe Medication Practices (ISMP), may occur as a result of drug labeling and packaging.
The FDA reportedly claimed that medication errors often happen as a result of names that look alike or sound alike, encoded numerals, failure to recognize active ingredients, dangerous medical abbreviations, and name length.
In a FDA workshop last month, Carol Holquist, RPh and director of FDA’s Division of Medication Error Prevention and Analysis reportedly claimed that guidance on these medication mistake issues is an important first step to developing a consensus to form new FDA regulations, which can take around 10-15 years.
The American Society of Health-System Pharmacists (ASHP)’s director of Medication Use Quality Improvement, Bona Benjamin, also reportedly told the workshop group that the ASHP’s 2007 recommendations for the FDA are still current—that human factoring should be applied scientifically to drug packaging and labeling, and barcode verification should be encouraged, as nearly 20% of hospitals are using barcode medication verification.
The U.S. Pharmacopeial Convention Health Literacy Panel also released label recommendations for dispensed prescription packaging in May, in an effort to reduce patient error, or patient injury. The panel called for organizing labels and presenting them to patients in a clear, concise, simple way that is standardized, to improve legibility, and use specific text to accurately describe drug dosages and directions, and to provide labeling in the patient’s preferred language.
Planned FDA Guidance on Drug Labeling Seeks to Help Reduce Medication Errors, Modern Medicine.com, July 20, 2010
USP Advisory Panel Recommends Standardizing Prescription Container Labeling to Improve Patient Understanding of Medication Instructions, PR Newswire/U.S. Pharmacopeial Convention, May 10, 2010
Related Web Resources:
U.S. Food and Drug Administration: Medication Error Reports