Compliant Medication Labels In The News
Articles & Mentions
Here's why it's so important that you take compliant medication labeling seriously. We've captured highlights of articles from regulatory, pharmacy and anesthesia industry publications related to medication labeling requirements and specifications with links to the full articles to raise your awareness.
Table of Contents:
Standard Specification for User Applied Drug Labels in Anesthesiology, ASTM D4774 - 11(2017)
This specification covers the size, color and pattern, and type used on labels applied to syringes filled by the users or their agents to identify the drug content. The size and background color requirements of drug labels are presented in detail.
Read the abstract here: https://www.astm.org/Standards/D4774.htm and purchase the full report from this link as well.
Statement on Labeling of Pharmaceuticals for Use in Anesthesiology, ASA, Last Amended: October 28, 2015 (original approval: October 27, 2004)
The primary consideration in the design of labels for syringes and drug infusion bags should be patient safety and the reduction of medication errors. This is particularly true for the potent medications used in the practice of anesthesiology. Therefore, the ASA supports the manufacture and use of labels meeting the following standards, which are consistent with those established by ASTM International (ASTM), the International Organization for Standardization (ISO), and the Institute for Safe Medication Practices (ISMP).
Download the full Statement here including information on label enhancements to reduce drug administration errors: https://www.asahq.org/standards-and-guidelines/statement-on-labeling-of-pharmaceuticals-for-use-in-anesthesiology
Color-Coded Syringes for Anesthesia Drugs—Use With Care: U.S. National Library of Medicine, National Institutes of Health, Journal List > Pharmacy and Therapeutics (P&T), 2012 April, Matthew Grissinger, RPh, FASCP
Since 2007, color-coded, pre-filled, anesthesia drug syringes from repackaging companies such as PharMEDium, Ameridose, CAPS, and others have been marketed to anesthesia providers (e.g., anesthesiologists, anesthetists, nurse-anesthetists). They have gained the attention of anesthesia providers who previously had to prepare and label all drug syringes themselves.
This article presents a word of caution: “Unless precautions are taken to prevent mix-ups with color-coded syringes, the Institute for Safe Medication Practices (ISMP) has concerns about the potential risks associated with devices. Although the ISMP has promoted color coding for user-applied labels among anesthesia providers, this system was not designed for labels used on commercial products.”
The ISMP, the American Medical Association (AMA), and the American Society for Health-System Pharmacists (ASHP), among other organizations have voiced concerns about over-relying on color-classification systems as the primary way to identify a drug. In 2005, Michael Cohen, ISMP President, testified before the FDA that color can be effective but only when it’s one of several variables: “When anesthesia providers prepare drugs in the OR, they follow these steps:
- retrieve the needed medication from a cart,
- read the vial or ampule label
- draw up the medication
- apply a color-coded adhesive label to the syringe.
In most cases, only a single agent within each drug class is needed. Each drug has its own color, and anesthesia providers know what is in each syringe because they prepared it.”
While pre-filled, color-coded syringes also have different colors for various drug classes of anesthetics, a risk remains: often there are multiple drugs within a class, each with very different properties. These drugs are all available in syringes of the same color—and sometimes in the same size. Using pre-filled, color-coded syringes, can result in the use of many different agents within a class that share syringes of the same color, thereby raising the risk that the clinician will select the wrong drug.
Read the full article here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351859/
Note: With Vigilant Labels’, case-specific label sets are printed on-demand. The labels are color-coded for various drug classes of anesthetics; however, the difference is that anesthesia providers apply the label to each syringe as they prepare it.
Syringe Labeling Compliance in an Academic Medical Center;
Objective: Measure anesthesia providers’ rate of compliance with written guidelines governing syringe labeling in the operating rooms of an academic medical center.
Not surprisingly, this study found no anesthesia provider in compliance with ASA/JC syringe labeling standards.
Read the abstract here:http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2011&index=15&absnum=5678
This result is all too common, and as the abstract concludes, indicative of a faulty system that requires mending. This is precisely why Click-to-Comply from Vigilant Labels was developed. The time-consuming and disruptive nature of handwritten labels and existing automated label printers fosters this poor compliance. With Click-to-Comply, proper syringe labeling takes only seconds and does not require anesthetizing teams to handwrite, use keyboards or keypads, or wait for individual labels to be printed one at a time.
The Joint Commission: National Patient Safety Goals Effective January 2017; NPSG.03.04.01
National Patient Safety Goal 3 is designed to improve the safety of using medications. It specifically requires providers “Label all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings.” The rationale is defined as follows:
“Medications or other solutions in unlabeled containers are unidentifiable. Errors, sometimes tragic, have resulted from medications and other solutions removed from their original containers and placed into unlabeled containers. This unsafe practice neglects basic principles of safe medication management, yet it is routine in many organizations.
The labeling of all medications, medication containers, and other solutions is a risk-reduction activity consistent with safe medication management. This practice addresses a recognized risk point in the administration of medications in perioperative and other procedural settings. Labels for medications and medication containers are also addressed at MM.05.01.09”
Download the full pdf version here to see the specific Elements of Performance for NPSG 03.04.01 beginning on page 2: https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2017.pdf
IV Product Labeling: Practices to Improve Patient Safety: January 2008, Pharmacy Purchasing & Products Magazine, Timothy S. Lesar, BS, PharmD
For IV drugs compounded in your pharmacy, follow ISMP’s recommendations in establishing your labeling standards. Put thought into how information will be expressed on your labels and where the labels will be placed on the IV bags. Label placement should allow for inspection of the critical information on the bag. In developing your label template, ask yourself the following:
- Is there enough white space on the label to promote readability?
- Is the font big enough?
- Are the colors used helpful in communicating vital information?
- Ask your staff members to review the template and several sample labels.
Read the full article here: https://www.pppmag.com/documents/V5N1/p2_4.pdf
Errors with Injectable Medications: Unlabeled Syringes are Surprisingly Common! ISMP Article: November 15, 2007
Research shows that the incidence of errors with injectable medications is higher than with other forms of medications. Several factors can increase the risk of errors and patient harm with injectable medications including preparation of the drug in clinical areas instead of the pharmacy.
Unlabeled syringes are a significant risk associated with preparation of injectable products in clinical areas. ISMP staff consultants frequently visit healthcare facilities and confirm that unlabeled syringes are observed in every patient care area, from typical nursing areas to diagnostic testing areas. This article discusses Safe Practice Recommendations: https://www.ismp.org/resources/errors-injectable-medications-unlabeled-syringes-are-surprisingly-common
Joint Commission: Pharmacy Rules/Regulations by State for Compliance with USP 797 Medication Compounding 2/28/2017
Download this sitemap for state by state rules for compliance with USP 797 Medication Compounding: https://www.jointcommission.org/assets/1/6/Feb_2017_State_Compounding_Regulations.pdf
Institute for Safe Medication Practices: ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations, Original Publication: 2013 Revised: 2016
Errors during pharmacy preparation of parenteral products and admixtures have frequently been reported to the ISMP National Medication Errors Reporting Program (ISMP MERP) and have also been a topic of discussion in the ISMP Medication Safety Alert!
Download the ISMP Guidelines pdf here: https://www.ismp.org/sites/default/files/attachments/2017-11/Guidelines%20for%20Safe%20Preparation%20of%20Compounded%20Sterile%20Preperations_%20revised%202016.pdf Specific guidelines for computer generated labels for CSP preparation start on page 15.
ASHP Guidelines on Compounding Sterile Preparations: Drug Distribution and Control: Preparation and Handling–Guidelines; American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:145–66.
Download the article here, https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/compounding-sterile-preparations.ashx including Packaging and Labeling information beginning on page 125.
USP General Chapter 797 Pharmaceutical Compounding – Sterile Preparations
USP General Chapter 797 describes a number of requirements and develops standards for preparing compounded sterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. Read the latest updates and proposed revisions here: http://www.usp.org/compounding/general-chapter-797
CMS Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications, Center for Clinical Standards and Quality/Survey & Certification Group, October 30, 2015
Hospital policies and procedures for the preparation and administration of all drugs and biologicals must not only comply with all applicable Federal and State laws and be consistent with accepted standards of practice based on guidelines or recommendations issued by nationally recognized organizations including (but not limited to):
- American Society of Health-System Pharmacists (http://www.ashp.org/default.aspx)
- Infusion Nurses Society (http://www.ins1.org)
- Institute for Safe Medication Practices (www.ismp.org)
- National Coordinating Council for Medication Error Reporting and Prevention (www.nccmerp.org)
- U.S Pharmacopeia (www.usp.org)
This guidance article includes specific labeling requirements for CSP preparation, including “beyond use date” labeling as follows: “Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer…,” the CSP must be labeled with at least:
- Patient identification information
- The names and amounts of all ingredients
- The name or initials of the person who prepared it; and
- The exact one hour “beyond use date” (see below).
Read the full article here, including the specific labeling requirements for CSP preparation beginning on page 8: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-01.pdf
Society for Technology in Anesthesia: Corporate Member
Vigilant Labels solves Anesthesia and PACU syringe labeling challenges through technology that fits the provider’s workflow. The Click-to-Comply solution allows providers to print USP 797 compliant labels in just two clicks. Stop handwriting your syringe labels. Stop worrying about Joint Commission or AAAHC site visits. Implement Vigilant Labels Click-to-Comply and simplify the burdens of syringe labeling.
Vigilant Labels is the “Maximum Funding” Entrepreneur Grand Prize Winner, Advisor News, December 14, 2017
Vigilant Labels was the grand prize winner of this competition for startups with its Click-to-Comply system. Founder Dr. Peter Baek developed Click-to-Comply to solve the critical workflow challenges faced by anesthesiologists, pharmacists and nurses to comply with medication labeling rules, regulations and best practices. The company improves anesthesia syringe labeling by utilizing technology and integrations to electronic medical record software systems. Vigilant Labels solves these complex challenges and the resulting benefits enhance patient safety, increase compliance and reduce costs for the healthcare provider.
How one doctor is making the Operating Room safer with Click-to-Comply; By anguyen posted 25/11/2017 In Life Sciences and Healthcare
Read about Dr. Peter Baek’s motivation to found Vigilant Labels: “Dr. Baek understood that it was difficult for nurse anesthetists and anesthesiologists to comply with strict regulations regarding medication labeling. For one, information on a syringe label is quite detailed … Yet, common practice is that this information is printed by hand which results in illegibility as the details are scribbled and squeezed together to fit the medication label. Dr. Baek therefore started Vigilant Labels to make the process easier and more efficient.