Epidural Label Safety Checklist Introduction
The Medication Safety Checklist for Epidural Labels is designed to:
- Heighten awareness of the characteristics of a safe label for medications intended for administration by the epidural route;
- Assist organizations to evaluate label content and design for epidural products;
- Provide a baseline for hospital efforts to enhance the safety of epidural medication use, at the individual facility and aggregate level
The checklist includes 24 assessment items divided into 4 sections covering the label content, label design, label position, and other considerations for labels for epidural products.
This checklist was informed by a prospective risk assessment project undertaken by an Ontario hospital evaluating the medication use process associated with epidural medications and planned changes to an external vendor for medication preparation.
The checklist was developed with stakeholder input and pilot tested in March 2015. The checklist was revised based on feedback from the pilot test and expert reviewers.
Why a checklist for epidural labels?
It is crucial to consider the intended use of the product and the needs of the end user for each medication label -- label content and design have been identified as contributing factors to numerous medication incidents.
The release of the Thiessen Review of the Oncology Under-Dosing Incident1 has resulted in increased attention to medication labelling in the oncology setting and beyond. Additionally, hospitals are increasingly turning to external compounders, e.g., specialty pharmacies, drug preparation premises (DPP), and manufacturers to support availability and integrity of parenteral products in order to ensure compliance with Accreditation Canada Medication Management Standards and United States Pharmacopeia (USP) requirements for sterile products. Use of external vendors may increase variability in label information content and design when compared to in-house preparation in hospitals.
Medications commonly administered by the epidural route include local anaesthetics and opioids. A key risk with these products is that they physically resemble products for intravenous administration; i.e., they are provided in minibags or parenteral syringes. While opioids are high-alert medications and, by definition, have a higher risk or patient harm if an error occurs, the greater risk of harm with epidural products is associated with incorrect administration of the local anaesthetic component. Local anaesthetics can be cardiotoxic if administered intravenously and fatalities have resulted when these mix-ups have occurred.2
About ISMP Canada's Medication Safety Self-Assessment and Safety Checklist Programs
ISMP Canada is not a standard-setting organization. As such, the assessment items in this checklist are not intended to represent a minimum standard of practice and should not be considered as such. Some of the items represent innovative practices and system enhancements that are not yet widely implemented. However, their value in reducing errors is grounded in scientific research and expert analysis of medication errors and their causes. Medication Safety Self Assessment and Checklist findings are intended for internal use and become more useful as repeat assessments are performed to see where improvements have been achieved over time.
The Epidural Label Safety Checklist and its components are copyrighted by ISMP Canada and may not be used in whole or in part for any other purpose or by any other entity except for self-assessment of medication systems by hospitals, and other pharmacy, manufacturing or compounding entities as part of their ongoing quality improvement activities.
1 Thiessen JJ. A Review of the Oncology Under-Dosing Incident. A Report to the Ontario Minister of Health and Long-Term Care, July 12, 2013. Available from: http://www.health.gov.on.ca/en/public/programs/cancer/drugsupply/docs/report_thiessen_oncology_under-dosing.pdf
2Epidural Medications Given Intravenously May Result in Death. ISMP Canada Safety Bulletin 2006; 6(7). Available from: http://ismp-canada.org/download/safetyBulletins/ISMPCSB2006-07Epidural.pdf