Drug Dilution Errors in The Operating Room. Operating Room Drug Safe Labelling System Update Needed

Question:

Recently our pharmacy replaced remifentanil 2 mg/ml vials with 1 mg/ml vials. To provide uniformity, syringe pumps used in our perioperative areas are programmed to default to 40 mcg/ml of remifentanil. Thus, remifentanil is now needed to be diluted to 25 ml instead of 50 ml with the diluent. In this instance, however, the drug was diluted to 50 ml with resulting concentration of 20 mcg/ml causing confusion while programming the appropriate dose on the syringe pump. Many drugs such as epinephrine, phenylephrine, and ephedrine are diluted in the operating room (OR) by the provider prior to administration to the patient. Although the Safe Label System displays if a drug requires dilution and the diluent based on the hospital’s formulary, it does not specify the volume of the diluent. I believe an opportunity thus exists to potentially minimize drug dilution error in the OR. An added display of volume of diluent required to obtain a certain concentration of the drug would avoid having to manually calculate the diluent volume possibly preventing a human error.

Gundappa Neelakanta MB,BS is a clinical professor in anesthesiology at David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA.

The author has no conflicts of interest.

Response:

The Anesthesia Patient Safety Foundation is committed to patient safety and has identified medication safety as one of its Perioperative Patient Safety Priorities. An integral part of this safety has been the installation of safe labelling systems in the operating room. A widely used system (CODONICS Safe Label System SLS 550i) recognizes, displays, and prints color coded syringe labels of drugs used in the operating room (OR) with name of the drug, its concentration, preparer’s initials, date and time of expiration and a bar code. It also gives audio feedback of the drug scanned with its concentration and dilution, if required. These labels comply with The Joint Commission NPSG.03.04.01*, and meet the intent of ISO 26825, ASTM 4774 Standards & ASA Guidelines.

Safe Label System uses barcode technology at the point of care and creates full color, easy-to read and ready-to-apply Joint Commission compliant syringe labels on demand. The system meets the ISMP Guidelines and their 2025 goals for perioperative/procedural areas as well as the APSF recommendations that every anesthetizing location should have a mechanism to identify medications before drawing them up or administering them (barcode reader). Over the last ten years, Codonics has received a few requests from our customers to provide ‘preparation instructions’ on the Safe Label System display. The feature is part of our test track database, which captures all customer product enhancement requests. To date, however, preparation instruction development has not been prioritized. Although our engineering staff has done some preliminary conceptualization of the functionality, it requires additional business justification and a better understanding of the anesthesia workflow in order to bring the feature to market. Certainly, Codonics is interested to discuss specific requirements with clinicians to ensure the final product enhancement meets customers’ needs. In fact, such collaboration has helped us to expand the value of Safe Label System, and we continue to invest in development and product improvements for our entire patient safety product line. The Safe Label System capabilities have expanded from providing safety and compliance in the operating room to delivering integration with anesthesia drug carts to reduce stock outs, with AIMS (Epic/Cerner) to improve charge capture and 340B accountability, and with the testing of waste and returns to help prevent drug diversion, as well as interoperability with smart pumps to reduce manual steps and human error. Finally, it will provide future integration with BD Intelliport. Codonics welcomes a future opportunity to work with clinicians on a solution with potential to help minimize drug dilution errors in this environment.

Cristy Berg CTSM
VP of Communications
Codonics

References

1. Anesthesia Patient Safety Foundation (APSF). APSF Perioperative Priorities and Ongoing Activities. APSF website https://www.apsf.org/patient-safety-priorities/
2. Codonics Patient Safety. Safe Label System. Codonics website. https://www.apsf.org/patient-safety-priorities/
3. The Joint Commission(TJC). NPSG (Effective Jan. 2021 for the Ambulatory Health Care Program.TJC website. https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2021/npsg_chapter_ahc_jan2021.pdf
4. Committee on Equipment and Facilities. Statement on Labeling of Pharmaceuticals for use in Anesthesia. Oct. 27, 2004. Dec. 13, 2020. https://www.asahq.org/standards-and-guidelines/statement-on-labeling-of-pharmaceuticals-for-use-in-anesthesiology