ALERT: Rocuronium Vials Lack Recommended Warning on Ferrule
The current COVID-19 pandemic has increased the demand for certain critical medications. The neuromuscular blocking agent rocuronium is one such medication. Neuromuscular blocking agents are high-alert medications and, when used in error, can lead to devastating injuries or death.
- Rocuronium 50 mg/5 mL (from Auro Pharma Inc.) has the warning “Paralyzing Agent” on the cap but lacks this warning on the ferrule (Figure 1); this is inconsistent with safety recommendations designed to mitigate the risk of errors with neuromuscular blocking agents.
- The warning on the vial label is hidden behind a peel away label (Figure 1) instead of being prominently displayed on the principal display panel.
- Risk reduction strategies are needed—in particular, applying end-user warnings to the vial and alerting staff—until planned changes are made by the manufacturer and the existing supply is depleted.
BACKGROUND
The current COVID-19 pandemic has increased the demand for certain critical medications. The neuromuscular blocking agent rocuronium is one such medication. Neuromuscular blocking agents are high-alert medications and, when used in error, can lead to devastating injuries or death.1
SAFETY CONCERN
FIGURE 1. Auro rocuronium vials without the “Paralyzing Agent” warning on the ferrule, nor prominently displayed on the principal display panel. (Image courtesy of Auro Pharma Inc.)
In accordance with recommendations established to address selection errors at the point of care,2,3 neuromuscular blocking agents in Canada should carry a prominent warning on the vial labels, cap, and ferrule.3 The Auro product does not carry the recommended warning on its ferrule, nor does it prominently display the warning on the principal display panel. It also lacks the recommended red cap and red ferrule with the warning in white lettering. This deviation from safe labelling and packaging recommendations increases the risk that this product may be misidentified and inadvertently administered.4
RESPONSIVE ACTION
FIGURE 2. Proposed improvements for Auro rocuronium vials: the “Paralyzing Agent” warning in white lettering on the red cap and red ferrule, and prominently displayed on the principal display panel (Images courtesy of Auro Pharma Inc.)
HealthPRO Procurement Services Inc. has communicated with Auro about the risk. The company has indicated that they will be changing the cap and ferrule to red, both of which will display the warning “Paralyzing Agent” in white letters (Figure 2). Auro will redesign the vial label to prominently display the warning on the principal display panel (Figure 2). The company will also provide an auxiliary label that includes the warning, for application to syringes. Auro has submitted the label changes to Health Canada for approval; however, until the new format becomes available, hospitals may be accessing the original supply. Auro and other Canadian manufacturers are to be commended for voluntarily implementing safety recommendations for labelling and packaging of neuromuscular blocking agents.2
RISK MITIGATION STRATEGIES
In the interim, until the current supply is exhausted AND the new stock is in use, hospitals that purchase the Auro rocuronium product should take the following precautions:1,4
- Apply end-user warnings, such as an auxiliary label indicating “Paralyzing Agent”, on the vial.
- Review how and where the product is stored, to ensure that such warnings are clearly visible.
- Assess the risk of a look-alike mix-up with existing products in the pharmacy, intensive care unit, or other areas where rocuronium would be used.
- Where available, use bar-code scanning technology throughout the medication-use process.
- Alert staff about the risk of errors.
The Canadian Medication Incident Reporting and Prevention System (CMIRPS) is a collaborative pan-Canadian program of Health Canada, the Canadian Institute for Health Information (CIHI), the Institute for Safe Medication Practices Canada (ISMP Canada) and Healthcare Excellence Canada (HEC). The goal of CMIRPS is to reduce and prevent harmful medication incidents in Canada.
Funding support provided by Health Canada. The views expressed herein do not necessarily represent the views of Health Canada.
The Healthcare Insurance Reciprocal of Canada (HIROC) provides support for the bulletin and is a member owned expert provider of professional and general liability coverage and risk management support.
The Institute for Safe Medication Practices Canada (ISMP Canada) is an independent national not-for-profit organization committed to the advancement of medication safety in all healthcare settings. ISMP Canada’s mandate includes analyzing medication incidents, making recommendations for the prevention of harmful medication incidents, and facilitating quality improvement initiatives.
Report Medication Incidents (Including near misses)
Online: ismpcanada.ca/report/
Phone: 1-866-544-7672
ISMP Canada strives to ensure confidentiality and security of information received, and respects the wishes of the reporter as to the level of detail to be included in publications.
Stay Informed
Subscribe to the ISMP Canada Safety Bulletins and Newsletters.
This bulletin shares information about safe medication practices, is noncommercial, and is therefore exempt from Canadian anti-spam legislation.
Contact Us
Email: cmirps@ismpcanada.ca
Phone: 1-866-544-7672
©2024 Institute for Safe Medication Practices Canada.