Beginning in 1997, the Institute for Safe Medication Practices (ISMP) reported on cases in which patients have inadvertently received the incorrect product due to mistakes involving unlabeled medications and solutions. Reports submitted to PA-PSRS reveal that unlabeled bowls, basins, and cups continue to present a problem.
One report described an occurrence in an operating room (OR) where Monsel’s solution (20% ferric subsulfate) and Lugol’s solution (potassium iodide) were both on the surgical field. The surgeon, wanting to use the Lugol’s solution, removed the Monsel’s bowl off the field without asking the scrub nurse to identify the solution. No further information was contained in the report. In another report highlighting what could have been a dangerous situation, three unlabeled basins that contained water, saline, and renografin solutions were found on a sterile back table in the OR.
Several reports outside of PA-PSRS that gained national attention illustrate the potential hazards of this practice. In one case, a 37-year old male patient’s genitals were severely burned when his physician mistakenly applied TBQ (a cationic germicidal detergent with a pH of 13) instead of vinegar for a wart removal. In another case, a patient was accidentally injected with hydrogen peroxide instead of lidocaine for local anesthesia. During the surgical procedure hydrogen peroxide was drawn into a syringe from an unlabeled basin instead of the intended lidocaine, which was also in an unlabeled cup. Even in the radiology department, unlabeled products can lead to tragic outcomes. For example, a patient was accidentally injected with lidocaine 2% instead of contrast media [Omnipaque (iohexol)] during angiography. The patient suffered a grand mal seizure but recovered.1
A report from Hospital Pharmacy in 1989 described the case of a patient who died during a surgical procedure to remove a cancerous eye. In this case, an unlabeled specimen cup was filled with glutaraldehyde to preserve the patient’s enucleated eye, but was mistaken as spinal fluid. The fluid had been removed to reduce pressure because the malignancy had spread to the brain. The spinal fluid was in an identical unlabeled cup. Near the end of the procedure, an anesthesiologist accidentally injected the glutaraldehyde intrathecally, believing it was the patient’s spinal fluid.2
Recent findings from the 2004 ISMP Medication Safety Self Assessment® for hospitals, gathered from more than 1,600 hospitals across the country, show that less than half (41%) of the hospitals always label containers (including syringes, basins, or other vessels used to store drugs) on the sterile field, even when just one product or solution is present. Eighteen percent do not label medications and solutions on the sterile field at all, and another 41% apply labels inconsistently. Although this represents an improvement from the 2000 findings (25% reported full labeling; 24% reported no labeling), surprisingly, this rather basic safety measure is not widely implemented in most hospitals.3
While you may not have experienced a Serious Event involving unlabeled medications and solutions, it is important to develop and implement policies and procedures for the safe labeling of these items, which are often used in sterile settings. These settings include operating rooms, ambulatory surgery units, labor and delivery rooms, physician’s offices, cardiac catheterization suites, endoscopy suites, radiology departments, and other areas where operative and invasive procedures are performed. Consider the following measures, most of which are mentioned in the Association of PeriOperative Registered Nurses (AORN) Guidance Statement: Safe Medication Practices in the Perioperative Practice Settings.4
Examples of safe practices to consider include:
- Making labeling easy by purchasing sterile markers, blank labels, and preprinted labels prepared by the facility or commercially available (e.g., Healthcare Logistics) that can be opened onto the sterile field during all procedures. To minimize staff time, prepare surgical packs in advance with sterile markers, blank labels, and preprinted labels for all anticipated medications and solutions that will be needed for the case.
- Using labels on all medications, syringes, medicine cups basins, or other containers of solutions as well as chemicals, reagents on and off the sterile field, even if there is only one medication or solution involved.
- If drug or solution names are similar, using tall man lettering on the labels to differentiate them (e.g., HYDROmorphone) or highlight/circle the distinguishing information on the label.
- When possible, purchasing skin antiseptic products in prepackaged swabs or sponges to clearly differentiate them from medications or other solutions to eliminate the risk of accidental injection.
- Individually verifying each medication and completing its preparation for administration, delivery to the sterile field, and labeling on the field before another medication is prepared.
- Verifying with the physician any medication on the physician’s preference list before delivery to the sterile field, labeling, and/or administration.
- Having the scrub person and circulating nurse concurrently verify all medications/solutions visually and verbally by reading the product name, strength, and dosage from the labels. If there is no scrub person, the circulating nurse could verify the medication/solution with the licensed professional performing the procedure.
- When passing a medication to the licensed professional performing the procedure, visually and verbally verifying the medication, strength, and dose by reading the medication label aloud.
- Keeping all original medication/solution containers the room for reference until the procedure is concluded.
- At shift change or relief for breaks, having entering and exiting personnel concurrently note and verify all medications and their labels on the sterile field.
- Not making assumptions about what is in an unlabeled basin, bowl, cup or syringe.
- Discarding any unlabeled medication/solution found and considering the occurrence as a near miss.
- Performing regular safety rounds in areas that routinely have basins, bowls, cups, etc., to observe labeling procedures, promote consistency, and inquire about barriers to change.
- ISMP. Medication Safety Alert! 18 June 1997. (2), 12.
- Cohen MR. Medication Error Reports. Hospital Pharmacy.1989;24(7).549.
- ISMP. Medication Safety Alert! 12 December 2004. (9), 24.
- Association of periOperative Registered Nurses (AORN). AORN Guidance Statement: Safe Medication Practices in Perioperative Practice Settings [online]. 2004. [Cited 22 Feb 2005.] Available on Internet: http://www.aorn.org/about/positions/pdf/7f-safemeds-2004.pdf.