Statement on Labeling of Pharmaceuticals Used in the Practice of Anesthesiology

Developed By: Committee on Equipment and Facilities
Last Amended: October 15, 2025  (Original Approval: October 27, 2004)

Accurate labeling of medications is an essential step in decreasing the risk of medication errors,^1-3 by influencing the selection of the correct medication, determining the correct dose to be administered, and verifying that the medication chosen has not passed its expiration time or date. This is especially true for the practice of anesthesiology, which involves administration of a wide variety of potent, rapidly-acting medications with diverse actions that are often used in the course of a single anesthetic, at times simultaneously. These medications, including sedatives, opioids, neuromuscular blockers, and vasoactive agents, are often given in high-acuity situations, in environments with high workload, poor visibility, and multiple distractions. Studies recognize that perioperative medication errors are a significant source of morbidity and, on occasion, mortality.^4-7 Concern about medication errors extends to regulatory agencies, the federal government, and the general public.

This statement emphasizes the importance of consistency and uniformity, when possible, in medication labeling to protect patient safety. The primary consideration for the design and use of labels for syringes, drug infusion bags, and medication containers in the practice of anesthesiology should be the reduction of medication errors and thus safer patient care. The ASA supports the manufacture and use of labels that meet the standards consistent with those established by ASTM International (formerly the American Society for Testing and Materials), the International Organization for Standards (ISO), U.S. Pharmacopeia (USP), as well as recommendations and guidelines from the U.S. Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP).

Label Content: Label content may differ depending on whether the label is applied to a syringe, used for infusion bags, or on medication containers such as vials and ampules. The most prominently displayed information on every label should be the generic name of each medication and concentration. Labels should also include the date and time of preparation of the medication, the preparer’s name or initials, and route of administration (when applicable). For infusion bags, anesthesiologists should identify a policy with their facility administration for when a patient’s name should be applied to a pre-filled infusion bag. Vials, ampules, syringes, and containers of medications intended only for regional anesthesia shall be clearly marked as such.

Font and Print Characteristics: The text on the label should be designed to enhance the legibility of the drug name and concentration as recommended by standard setting organizations like ASTM International and ISO. 

Text and Background Contrast: Maximum contrast between the text and background should be provided by the use of high-contrast color combinations.

Reserved Colors: Nine classes of drugs commonly used in the practice of anesthesiology have standard background/text colors for user-applied syringe labels established by ASTM International and ISO: (1) Induction agents; (2) Benzodiazepines and their antagonists; (3) Neuromuscular blockers and their antagonists; (4) Opioids and their antagonists; (5) Anti-emetics; (6) Vasopressors and hypotensive agents; (7) Local anesthetics; (8) Anti-cholinergic agents; and (9) Beta-blockers. Label colors are intended only as an aid in identification of drug classes. The user should always read the label and correctly identify the drug prior to administration. 

Label Material: Label material should allow the user to write information on it using a ball-point pen or felt-tip marker without smudging or blurring.

Additional Considerations:

Bar Codes: Bar coding on labels, required by the FDA for medication containers since 2004⁸, can be utilized in several ways. Bar codes contain the drug’s National Drug Code (NDC) number, which is associated with the generic name and strength.⁹ When medications are bar coded, there is an opportunity for reduction of a number of medication errors. Electronic label printers can read the medication name and concentration from a medication vial and quickly print a syringe label that may be more legible and complete than one written by hand. Some electronic label printers may verbally confirm the medication (adding a second-check that is often missing from anesthesia practice).¹⁰ Additionally, a bar code scanner or label printer might populate the electronic record, or apply a machine-readable element to the syringe label for scanning, thereby decreasing workload and potentially reducing the risk of a medication error.¹¹

Text Modification: Text modifications are used to reduce the likelihood of medication errors related to look-alike drug names. Tall Man Lettering (TML) is currently used to visually differentiate their established names. Other methods for modifying text have been studied but are not widely used at this time (e.g., font color). Anesthesiologists should be familiar with TML drug names recommended by the FDA and ISMP that are commonly administered.^12,13

Regulatory Considerations: Anesthesiologists should be aware of regulatory agencies and accrediting organization standards regarding medication labeling. For example, The Joint Commission (TJC) National Patient Safety Goal (NPSG) 03.04.01 is used to improve safety of using medications. The NPSG describes multiple elements of performance for medication labelling in perioperative and other procedural settings, including a description of immediately administered medications.¹⁴

Placement of Syringe Labels: Consistent labeling practices, including how the label is applied to the syringe, may reduce medication errors. Labels should be placed in a way that avoids obstructing the view of gradations on the syringe barrel and its contents (e.g., a label at the top of the syringe barrel should not obscure the full extent of the solution in the syringe). The label should ideally be applied longitudinally, directly adjacent to the gradation lines so that the scale, name, strength, and dose of the drug are visible during administration.^15,16

Readability and Recognition of Color: Use of color can affect the ability of anesthesiologists and others to read labels. Although standard setting organizations specify color-coding for syringe labels, impaired color vision may affect a clinician's ability to distinguish between different-colored labels.^16-19 The use of laser goggles may also affect the ability to accurately discern syringe label colors.^20,21 Readability may also be affected by low light conditions. Anesthesiologists should be aware of such considerations and make appropriate modifications to ensure medication safety.

Regardless of the patient safety labeling features described above, reading the label prior to drug administration remains the most important and essential action for reducing medication errors.

Additional Information:
ASA Committee on Equipment and Facilities maintains a more complete discussion of its recommendations as a committee resource for the labelling of pharmaceuticals used in the practice of anesthesiology. 

References:

1. Merry AF, Shipp DH, Lowinger JS. The contribution of labelling to safe medication administration in anaesthetic practice. Best Pract Res Clin Anaesthesiol. 2011; 25:145-159.
2. Orser BA, Chen RJB, Yee DA. Medication errors in anesthetic practice: a survey of 687 practitioners. Can J Anaesth. 2001; 48:139-146.
3. Wahr JA, Abernathy III JH, Lazarra EH, Keebler JR, Wall MH, Lynch I, Wolfe R, Cooper RL. Medication safety in the operating room: literature and expert-based recommendations. BJA. 2017; 118:32-43.
4. Currie M, Mackay P, Morgan C, Runciman WB, Russell WJ, Sellen A, Webb RK, Williamson JA. The “wrong drug” problem in anaesthesia: an analysis of 2000 incident reports. Anaesthesia and Intensive Care. 1993; 21:596-601. 
5. Fasting S, Gisvold SE. Adverse drug errors in anesthesia, and the impact of coloured syringe labels. Can J Anesth. 2000; 47:1060-1067. 
6. Merry AF, Webster CS. Labeling and drug administration error. Anaesthesia. 1996; 51:987988. 
7. Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of perioperative medication errors and adverse drug events. Anesthesiology. 2016; 124:25-34. 
8. Food and Drug Administration. Bar code label requirement for human drug products and biological products. https://www.govinfo.gov/content/pkg/FR-2004-02-26/pdf/04-4249.pdf. Accessed June 25, 2025.
9. ASTM Designation: D6398 − 08 (Reapproved 2014), Standard Practice to Enhance Identification of Drug Names on Labels.
10. Orser BA, U D, Cohen MR. Perioperative medication errors: building safer systems. Anesthesiology. 2016; 124:1-2.
11. Jelacic S, Bowdle A, Nair BG, Kusulos D, Bower L, Togashi K. A system for anesthesia drug administration using bar code technology: The Codonics Safe Label System and Smart Anesthesia ManagerTM. Anesth Analg. 2015; 121:410-421.
12. Institute for Safe Medication Practices (ISMP). FDA and ISMP Lists of Look-Alike Drug Names with Recommended Tall Man Letters. https://www.ismp.org/sites/default/files/attachments/2017-11/tallmanletters.pdf. Accessed June 25, 2025.
13. U.S. Food and Drug Administration. FDA Name Differentiation Project.: FDA List of Established Drug Names Recommended to Use Tall Man Lettering (TML). Content current as of 04/28/2020. https://www.fda.gov/drugs/medication-errors-related-cder-regulated-drug-products/fda-name-differentiation-project. Accessed June 25, 2025.
14. The Joint Commission. National Patient Safety Goals. https://www.jointcommission.org/standards/national-patient-safety-goals/. Accessed June 25, 2025.
15. Grissinger M. Reducing errors with injectable medications: unlabeled syringes are surprisingly common. P&T. 2010; 35:428-429.
16. ASTM Designation: D4774 – 11, Standard Specification for User Applied Drug Labels in Anesthesiology. 
17. ISO 26825:2008, Anaesthetic and respiratory equipment – User-applied labels for syringes containing drugs used during anaesthesia – Colour, design and performance.
18. Filiatrault P, Hyland S. Does colour-coded labelling reduce the risk of medication errors? Can J Hosp Pharm. 2009; 62:154-156.
19. Grigg EB, Roesler A. Anesthesia medication handling needs a new vision. Anesth Analg. 2018;126:346-350.
20. Boucek C, Freeman JA, Bircher NG, Tullock W. Impairment of anesthesia task performance by laser protection goggles. Anesth Analg. 1993; 77:1232-1237.
21. Park JC, Herbert EN. Laser goggles alter the perceived colour of drug labels, increasing the risk for drug errors. Can J Ophthalmol. 2013; 48:e27-e28.