Medication Labels Need Practical Standards

John Beauregard, MD

Letters To The Editor:

Dr. Foster gave an excellent review on the history, current status, and future for drug labeling in the operating room. I would like to express a personal concern regarding the labeling issue. While I strongly believe that labeling of syringes is critical to patient safety, I am concerned that in an age of overregulation, rules devoid of common sense may be placed upon us by the regulating and accreditation bodies. Few would argue that unlabeled syringes pose a potential danger to patients. Propofol may be an exception since no other medication in the operating room is similar in appearance. (However, even propofol should be labeled if anything is added to it.) Even an unlabeled syringe does not seem unreasonable in a dire emergency when left in the vial from which it was drawn up, if discarded soon afterwards. But the potential for catastrophic iatrogenic patient injuries is tremendous if the syringe is not labeled with the contents and concentration of the medication. Imagine administering succinylcholine thinking that it is midazolam! However, should an anesthesiologist have to worry about being cited by a regulating body or an accreditation organization because the syringes at his side are not timed, dated, and initialed by the physician who drew them up? Would criticism be warranted if the syringe were not labeled as to the concentration of medication when only one standard concentration is available? Common sense would dictate that any medication that is altered in concentration, available in different concentrations, or has other medications added to it must be labeled as to content and concentration especially if the anesthesiologist will not be in attendance for 100% of the case. But should we be cited if we did not record for example, that the concentration of fentanyl was 50 µg/ml when that concentration is the only concentration offered in the institution? I agree with the premise that concentration changes should be recorded on a nonstandard label to prevent the assumption by a different caretaker that the medication is a standard concentration.

Patient safety regarding drug administration depends both on a system which reduces errors, i.e., vial and syringe labeling, and a compulsive practitioner who establishes and maintains safe habits, especially pertaining to drug administration. This includes careful examination of the vial before drawing up medicine as to content and integrity, labeling of the syringe, checking the label before inserting it into the IV tubing, and double-checking as the syringe is placed back on the cart. There is no substitute for this compulsive attitude and the establishment of safe habits in the practitioner. Bar-coding may help the system, but the actions of the practitioner are paramount.

It is my hope that the Anesthesia Patient Safety Foundation will encourage the JCAHO and others to establish practical standards with respect to drug labeling in the operating room, so they do not institute onerous and unrealistic “standards” on all of us.

John Beauregard, MD
Washington, DC