Volume 4, No. 3 • Fall 1989

Drug Accident Shows Need for Label Standards

David Eric Lees, M.D.

To the Editor

“The best laid schemes o’ mice and men gang aft a-gley.”

In the December, 1987 issue of the Anesthesia Patient Safety Foundation Newsletter an article entitled “Better Labels Will Cut Drug Errors” detailed the efforts of the D4267 Committee of the American Society for Testing and Materials (ASTM) to reduce medication errors by improving labeling, legibility, and color coding of anesthetic drugs.

The author of the article, Dr. Leslie Rendell-Baker, noted, however that even with the efforts of the ASTM committee, “There still remains the manufacturer’s tendency to adopt labels designed to identify dearly all their own products rather than using different designs for each group of products”.

A recent event at a university hospital in the Northeast illustrated Dr. Rendell-Baker’s point all too well. A resident from another training program was accepted for a one month cardiac anesthesia rotation at the university program. The resident prepared the room and drugs according to the university hospital’s protocols, but, unfortunately (unknown to the staff at the university hospital), the resident brought his own drug labels from his parent program. The resident’s parent program continued to use the older non-ASTM color coded anesthesia drug labels, whereas the university hospital program used the ASTM D42 67 anesthesia drug labels. During the conduct of the anesthetic, the university hospital attending physician supervising the resident accidentally administered an incorrect drug, assuming that the syringe has been labeled according to the university hospital protocol.

Obviously, several errors were made. The resident should not have brought materials, be they drugs, equipment or labels, from another hospital and the attending physician should not have given anesthesia “by colors”. It does illustrate, however, the point that primary reliance on a backup safety mechanism may act to your detriment. This standard is not meant to preclude reading and confirming the syringe or vial labeling. In aviation safety circles, this is referred to a “primary backup inversion”, where the primary system which is the human and human vigilance become the backup system and the backup system (color coding) becomes the primary.

The bigger problem and question, however, is why several years after the standard had been published, a major manufacturer still produces “the familiar colors” that have been “traditionally supplied” to the anesthesia community as well as the “new color code standards”? The manufacturer would only make the older product if there was still a demand within the anesthesia community. Obviously, more information on the new standard is necessary. Practicing anesthesiologists must purchase the new labels and manufacturers should withdraw the older labels from the marketplace.

It is not enough for organizations to participate in the drafting of voluntary consensus standards; once completed and endorsed, these standards must be publicized and marketed to both consumers and manufacturers.

David Eric Lees, M.D., Professor and Chairman, Department of Anesthesiology, New York Medical College.