September 30, 2011: Narcotic (Opioid) Medication Safety - Manufacturer Enhances Safety by Changing Vial Closures for Injectables
Sandoz Canada Inc. and ISMP Canada received reports of concerns about “tip-off” closures that were in use for a variety of injectable opioid medications manufactured by this company (see Figure 1). Reporters found that a “tip-off” closure could be replaced onto a vial after it had been opened, with little or no evidence of tampering. As such, the medication could be withdrawn and replaced with another substance, such as normal saline.Medication incidents occurred in the hospital setting in which patients had insufficient treatment of their pain. Incidents with oversedation also occurred when a higher opioid dose was prescribed on the assumption that the previous dose had been ineffective.
ISMP Canada worked in consultation with HealthPRO Procurement Services (an organization that also advised ISMP Canada of reports of product problems) and provided information to Sandoz Canada Inc. After careful analysis of the situation, the manufacturer decided to change the packaging for all injectable opioid medications that were available in a vial with a “tip-off” closure to the more commonly used closure (see Figure 2). Closures have now been changed for all of the opioid products manufactured by Sandoz Canada Inc. that are currently on the Canadian market.
ISMP Canada thanks the reporters and HealthPRO for sharing information related to these incidents, and thanks Sandoz Canada Inc. for implementing this change to improve patient safety.
