Background: Pharmacies rely on printing software for labeling drugs. Software typically interfaces with electronic medical record to reduce error by automation, producing an adhesive label. Pharmaceuticals requiring dilution,... [ view full abstract ]
Background: Pharmacies rely on printing software for labeling drugs. Software typically interfaces with electronic medical record to reduce error by automation, producing an adhesive label. Pharmaceuticals requiring dilution, doses prescribed to pediatric patients, and drugs administered by syringe pump all run a labeling error risk because they must be dispensed to the user in containers not labeled by the manufacturer. We report a 10-fold drug overdose caused by a design and usage flaw in pharmacy labeling, and discuss ergonomic issues related to labeling intravenous preparations in high intensity and acuity environments like the operating room.
Methods/Case: A 15-year-old healthy girl with scoliosis underwent thoracic posterior spinal instrumentation and fusion. Anesthesia was induced with sevoflurane with propofol and remifentanil maintenance infusions. Tranexamic acid was administered with loading dose of 10mg/kg over 20 minutes, followed by an infusion of 5mg/kg/h. This dose has been shown to maintain therapeutic levels in children, and was administered by a syringe pump (Medfusion 3500, Smiths Medical ASD Inc., St. Paul, MN, USA)from a 60ml syringe that was dispensed from the operating room pharmacy. Although these pumps have “drug libraries” which load preset parameters for each drug, the hospital has not implemented that software; instead the pumps are manually user programmed. After completion of loading dose, maintenance infusion was begun after confirming the pump was programmed in accordance with the syringe label, which depicted a concentration of 5mg/ml. Soon after starting surgery the pump alarmed,indicating a near empty syringe, which alerted the anesthesiologist that there was a problem, as the syringe should have lasted the entire case. Upon close inspection, it was noted that the label was ripped and stuck back on the syringe, obscuring the “0” in the drug concentration, which should properly have read “50mg/ml” rather than 5mg/ml. The infusion was stopped, and the patient suffered no consequences of the error.
Results/Discussion: There are many regulations that stipulate how manufacturers must design drug vial labels, however despite numerous studies and advisories about optimal labeling of syringes and infusions, there is no standardized labeling practice after dilution, reconstitution, or preparation of drugs. Indeed,there is often no communication between the pharmacy and end-user(anesthesiologist or nurse) regarding formatting or use of drug labels to enhance safety and identification. Labels can emphasize data of little use to the clinician while obscuring the information that is critical for safe administration of the drug. Labels not specifically designed to fit on syringes further obscure these data, and orientation of print and international standardized color codes may be ignored.
Conclusions: Hospital pharmacies and anesthesiologists must work together to utilize drug labels that are designed to enhance readability and instantaneous recognition of clinically important drug information, especially when syringes are mounted in pumps. Labeling of syringes with stickers not optimized for this purpose compound the risk of drug errors.This is of greater importance as anesthesiologists rely on pharmacies to mix and prepare drugs. Standardized concentrations with pre-programmed pump drug libraries, use of barcodes or RFID may also be effective strategies to reduce errors.
