Statement on Labeling of Pharmaceuticals for Use in Anesthesiology

Developed By: Committee on Equipment and Facilities
Last Amended: December 13, 2020 (original approval: October 27, 2004)

Statement: The primary consideration for the design and use of labels for syringes, drug infusion bags, and medication containers should be the reduction of medication errors and thus safer patient care. This is particularly true for the potent medications used in the practice of anesthesiology. Therefore, the ASA supports the manufacture and use of labels that meet the standards described below, which are consistent with those established by ASTM International (formerly the American Society for Testing and Materials), the International Organization for Standards (ISO), as well as recommendations and guidelines from the Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP).

Label content: Syringes: The drug's generic name and concentration (in units per mL) should be the most prominent items displayed on the label of each syringe. The date and time of preparation, and the preparer's initials or name, should also be included. The patient's name and route of administration may also be printed on the label. Infusions: For infusion bags containing pharmaceuticals for use in the practice of anesthesiology, the total volume of the bag and the generic name and amount of each added pharmaceutical should be the most prominently displayed information. The final concentration of each pharmaceutical in units per mL should also be displayed, as well as the date and time of preparation, the preparer's name or initials, and the patient's name. Vials and ampules: Medication containers intended for use in the practice of anesthesiology should display the generic name and concentration (as the total amount of medication in the container divided by the total volume) most prominently. Preferably, the concentration in units per mL is also displayed. 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 in ASTM D4267, Standard Specification for Labels for Small-Volume (100 ml or less) Parenteral Drug Containers, ASTM D6398, Standard Practice to Enhance Identification of Drug Names on Labels, ASTM D4774, Standard Specification for User Applied Drug Labels in Anesthesiology, ASTM D4775, Standard specification for identification and configuration of prefilled syringes and delivery systems for drugs (excluding pharmacy bulk packages), and ISO 26825:2008, Anaesthetic and respiratory equipment – User-applied labels for syringes containing drugs used during anaesthesia – Colour, design and performance. These standards include recommendations for font size, extra space for separation around the drug name to improve readability, and the use of additional emphasis for the initial syllable, or a distinctive syllable, for drugs with similar names.

Text/Background contrast: Except as specified under "Reserved colors" below, maximum contrast between the text and background should be provided by the high-contrast color combinations specified in Section 6.3.1 of ASTM D6398-08, as shown in the table below. This reduces the impact of color blindness.

Reserved colors: Nine classes of drugs commonly used in the practice of anesthesiology have standard background/text colors established for user-applied syringe labels by ASTM D4774-11, Standard Specifications for User Applied Drug Labels in Anesthesiology and ISO 26825:2008, Anaesthetic and respiratory equipment – User-applied labels for syringes containing drugs used during anaesthesia – Colour, design and performance (which specifies only eight; beta-blockers are not included): (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 (see table, below). Text is black on the specified background color for most agonist agents, and is black on the white-striped specified background color for most antagonist agents. For two special medications, succinylcholine and epinephrine, text is the specified color on a black background bar at the top of the label.

IMPORTANT: The colors represented in this electronic file are not intended to be used for color matching.

NOTE: RGB (Red, Green, Blue) is used only for digital (computer-based) designs. Any design created with an RGB color profile must be converted to CMYK (Cyan, Magenta, Yellow, blacK) or PMS color codes before printing. As a rule of thumb, RGB should only be used when designing for computer-based applications.

Label material: the material used for the label shall allow the user to write information on it using a ball-point pen or felt-tip marker without smudging or blurring as specified in Section 2.3 of ISO 26825:2008.

Rationale: Labeling of medications is an essential step in decreasing the risk of medication errors,^1-3 and influences selection of the correct medication, determining and then administering the correct dose, and ensuring 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 medications. Medications with widely differing actions, for example, sedative/hypnotics, opiates, neuromuscular blockers, vasopressors, and vasodilators, are often used in the course of a single anesthetic, at times simultaneously. These medications are often given in high-acuity situations, in environments with high workload, poor visibility, and multiple distractions. It is recognized that perioperative medication errors are a significant source of morbidity and, rarely, mortality.^4-7 Concern about medication errors extends to regulatory agencies, the federal government, and the general public.

This document is intended to provide information to several different populations, for multiple purposes. Each has its own needs and requirements with regard to labeling. This statement can help clinicians to understand the importance of labeling, especially syringe labeling, as well as provide guidance on best practices for labeling. Furthermore, it can help to guide decisions about selection and purchase of labeling products. It can provide guidance to medication manufacturers, who usually print their own labels for medication containers, and suggest ways to better support clinicians who use their products. Producers of pre-printed labels, including those who make pre-filled syringes, or manufacturers of label printers intended for use at the point of care, can utilize the information in this statement to better align their products with recommended practices.

Labels may be applied in various circumstances. They are most commonly applied to syringes drawn up by anesthesia providers at the point of care. They may also be prepared and labeled in an on-site pharmacy. Additionally, it is increasingly common for pre-filled and pre-labeled syringes to be supplied by manufacturers. Infusion bags are labeled by the manufacturer, and additional labels are applied by the on-site pharmacy or by the provider at the point of care, when medications are added. Medication containers are labeled by drug manufacturers. Different standards apply for each of these situations, and they are currently not unified.

Medications are often identified and selected based upon their location as well as visual features of the container/syringe. The recognition and identification of such an object depends on shape, color, brightness, and contrast; as these elements become increasingly distinctive, identification of the object becomes faster and more accurate.^8-11 Identification of a medication is verified by reading the label. Therefore, although multiple factors contribute to medication errors, consistency and clarity of pharmaceutical and syringe labeling, in accordance with human factors principles, remain important elements of error prevention.

Additional Considerations:

Label enhancements: Bar coding on labels, required by the FDA for medication containers since 2004¹², can be utilized in several ways. The bar code contains the drug’s National Drug Code (NDC) number, which is associated with the generic name and strength, at a location on the label which will not interfere with the label’s legibility, as specified in Section 8 of ASTM D6398.¹³ When medications are bar coded, there is an opportunity for reduction of a number of medical errors. Electronic label printers can read the medication name and concentration from a medication vial and quickly print a syringe label that is more legible and complete (e.g., patient name, expiration time or date) than one written by hand. The electronic label printer can potentially verbally confirm the medication (adding a second-check that is often missing from anesthesia practice)¹⁴. Additionally, a bar code scanner or label printer might populate the electronic record, or apply a machine-readable element to the syringe label that can be scanned into the electronic record as the medication is administered, thereby decreasing workload and potentially reducing the risk of a medication error.¹⁵

Lettering: In 2001, the FDA Office of Generic Drugs requested manufacturers of sixteen look-alike name pairs to voluntarily revise the appearance of their established names in order to minimize medication errors resulting from look-alike confusion. Letters from the FDA encouraged manufacturers to revise labels and labeling, using TALL MAN lettering (TML) to visually differentiate their established names. Since then, the FDA and ISMP have expanded the list to include other easily confused generic and brand names. TML can be used along with color or bolding to draw attention to the dissimilarities. The following table, showing TML drug names of easily confused medication names that may be administered by the anesthesia care team during a procedure, is taken from lists compiled by the FDA and ISMP.^16,17

* Brand names, which always start with a capital letter

Regulatory requirements: National Patient Safety Goal (NPSG) 03.04.01, to improve the safety of using medications, was first introduced by The Joint Commission (TJC) in 2007.¹⁸ It defines TJC Elements of Performance (EP) for labeling of medications and solutions in the perioperative setting, both on and off of the sterile field. Several requirements for compliance with this NPSG are relevant to this Statement. First, all medications and solutions that are not immediately administered must be labeled. A medication that is immediately administered is defined as one that is prepared or obtained, taken directly to a patient, and administered to that patient, without any break in the process. Second, each medication must be labeled as soon as it is prepared, which is when it is taken from its original packaging and transferred to another container. Third, the label must include the following information: medication or solution name, strength, amount of the medication or the solution containing the medication (if not apparent from the container), diluent name and volume (if not apparent from the container), and either expiration time (when expiration occurs in less than 24 hours) or date (when not used within 24 hours). However, the date and time are not necessary for short procedures, as defined by the organization. It can be inferred from the EP describing when a label is to be applied that syringes should be labeled and filled (in that order) one at a time. Finally, any medication or solution found unlabeled should be discarded.

Placement of syringe labels: While unlabeled syringes are known to be problematic, labels placed on syringes can also promote error. Consistent labeling practices, including how the label is applied to the syringe, may reduce medication errors. If the label is applied in such a way as to not be visible at the time the medication is administered, or if the label covers the gradations on the syringe, a "syringe swap" (medication error where the wrong medication is administered) may occur or an incorrect dose may be given. Labels should therefore 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). It has been recommended that the label should be applied directly below the gradation lines so that the scale, name, strength, and dose of the drug are visible during administration.¹⁹

Readability and color recognition: ASTM²⁰ and ISO²¹ standards specify color-coding for syringe labels. However, the use of color-coding for anesthesia syringe labels remains controversial.^22-24 The impact of color blindness may affect a clinician's ability to distinguish between different-colored labels. The use of laser goggles may also affect the ability to accurately discern syringe label colors.^25,26 Readability may also be affected by low light conditions. Further research into the effectiveness of color coding, especially given the advent of newer technologies that hold promise to reduce medication errors, seems warranted.²⁴ Given these considerations, it remains important for clinicians to use all available methods to ensure medication errors do not occur, including reading labels.

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. Treisman A. Feature and objects in visual processing. Scientific American. November 1986; pp: 114-125.
9. Triesman A. Features and Objects. Quarterly J of Exp Psychology. 1988; 40A (vol 2) 201-237.
10. Kosslyn SM. Aspects of a cognitive neuroscience of mental imagery. Science. 1988; 240:1621-1626.
11. Grigg EB, Martin LD, Ross FJ, Roesler A, Rampersad SE, Haberkern C, Low DKW, Carlin K, Martin LD. Assessing the impact of the anesthesia medication template on medication errors during anesthesia: a prospective study. Anesth Analg. 2017; 124:1617-1625.
12. 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 December 29, 2019.
13. ASTM Designation: D6398 − 08 (Reapproved 2014), Standard Practice to Enhance Identification of Drug Names on Labels.
14. Orser BA, U D, Cohen MR. Perioperative medication errors: building safer systems. Anesthesiology. 2016; 124:1-2.
15. 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.
16. Institute for Safe Medication Practices (ISMP). Look-Alike Drug Names with Recommended Tall Man Letters; 2016. https://www.ismp.org/tools/tallmanletters.pdf. Accessed December 29, 2019.
17. FDA Name Differentiation Project. FDA List of Established Drug Names Recommended to Use Tall Man Lettering (TML). Content current as of 9.4.2019. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm164587.htm. Accessed December 29,2019.
18. The Joint Commission. National Patient Safety Goals Effective January 2020. https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/npsg_chapter_hap_jan2020.pdf. Accessed December 29, 2019.
19. Grissinger M. Reducing errors with injectable medications: unlabeled syringes are surprisingly common. P&T. 2010; 35:428-429.
20. ASTM Designation: D4774 – 11, Standard Specification for User Applied Drug Labels in Anesthesiology.
21. ISO 26825:2008, Anaesthetic and respiratory equipment – User-applied labels for syringes containing drugs used during anaesthesia – Colour, design and performance.
22. Filiatrault P, Hyland S. Does colour-coded labelling reduce the risk of medication errors? Can J Hosp Pharm. 2009; 62:154-156.
23. Janik LS, Vender JS, Gissinger M, Litman RS. Pro/Con debate: Color-coded medication labels. Anesthesia Patient Safety Foundation Newsletter. February 2019, 33:74-75. Available at https://www.apsf.org/newsletter/february-2019/. Accessed December 29, 2019.
24. Grigg EB, Roesler A. Anesthesia medication handling needs a new vision. Anesth Analg. 2018;126:346-350.
25. 25.  Boucek C, Freeman JA, Bircher NG, Tullock W. Impairment of anesthesia task performance by laser protection goggles. Anesth Analg. 1993; 77:1232-1237.
26. 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.

Useful Websites:

For referenced ASTM International standards, visit the ASTM Website Reading Room at:
http://www.astm.org/READINGLIBRARY/ (Accessed December 29, 2019)
or, send an email to ASTM customer service at: [email protected]

For referenced ISO standards, visit the ISO (International Organization for Standardization) Website at: http://www.iso.org/iso/home.html (Accessed December 29, 2019)

FDA Name Differentiation Project
http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm164587.htm
Accessed December 29, 2019

FDA/ISMP Tall Man Letters
ISMP List of Look-Alike Drug Names with Recommended Tall Man Letters; 2016
https://www.ismp.org/tools/tallmanletters.pdf
Accessed December 29, 2019.

Safe Practice Guidelines for Adult IV Push Medications, 7.23.2015?
Institute for Safe Medication Practices (ISMP). ISMP Safe Practice Guidelines for Adult IV Push Medications; 2015. https://www.ismp.org/guidelines/iv-push
Accessed December 29, 2019

FDA Bar Coding Requirement
https://www.govinfo.gov/content/pkg/FR-2004-02-26/pdf/04-4249.pdf
Accessed December 29, 2019