In several of our recent columns on the recent fatal accident with the neuromuscular blocking agent vecuronium, we discussed the role of inadequate warnings (see our Patient Safety Tips of the Week for December 11, 2018 “Another NMBA Accident”, January 1, 2019 “More on Automated Dispensing Cabinet (ADC) Safety” and February 12, 2019 “From Tragedy to Travesty of Justice”). We’ve recommended that the warning on the ADC screen should be one that requires verification that the patient is intubated/ventilated or that the drug is being used to facilitate intubation. A high alert medication like an NMBA should also require an independent double check. And the warning on the vial of vecuronium obviously was not salient enough to attract the attention of the nurse who prepared and administered the vecuronium to a patient who was not being ventilated. And a barcoding system was not operational in the radiology area where the drug was administered. There were multiple other factors contributing to the cascade of events that led to the fatal outcome but the above are examples of where effective warnings could have averted this tragic outcome.
Inadequate warnings have also been contributing factors to many other serious medication-related incidents. So it is very timely that ISMP has highlighted the problem in one of their recent Medication Safety Alerts (ISMP 2019). This is an outstanding article that uses multiple human factors concepts and empirical evidence to make recommendations that should help all organizations that deal with medications.
ISMP notes that a warning system may include several components that complement each other and various forms of technology. ISMP notes that the ability of warnings to be effective depends on their ability to:
1. reach their target audience
2. capture the attention of recipients at the right time
3. cause recipients to understand the risk, believe that the warning relates to them, and understand the actions they need to take
4. lead the recipients to respond appropriately
ISMP notes that practitioners will not typically search for or seek out warnings. So, warnings must be sufficiently conspicuous to capture attention. The article discusses in detail the following important features of warnings:
· Target audience
· Source credibility
· Clinical importance
· Font size and text format
· Font style
· Letter case
· Signal words
· Color
· Affirmative wording
· Pictorials
· Placement
· Physical interactivity
· Specifics for electronic alerts
· Usability testing
· Perception of risk
We encourage you to go to the ISMP article for details on each of those. For example, under “signal words” they note that “Danger” is more likely to attract attention than “Caution” or “Warning”. They also note that signal words may be used in either auditory or visual warnings.
The section on “Specifics for electronic alerts” is very important. It describes location of text in the visual field and the importance that no scrolling be required in the main message (noting a difference between primary and secondary text). The most critical warnings should be interactive (modal) and should shade the rest of the screen while being presented. It discusses how options that require a response should be presented and that the safest choice should be presented first and should be the default option.
This ISMP article is a “must read” for anyone dealing the patient safety and all healthcare workers who deal with medications. Many of the concepts also apply to warnings that may apply to things other than medications (for example, oxygen, other medical gases, various medical devices, etc.).
And, just because you can design an effective warning, don’t forget the best preventive action in many cases is not give the healthcare worker the opportunity to select the dangerous medication in the first place. For example, do not put neuromuscular blocking agents in places they don’t belong. NMBA’s should only be kept in areas where they are truly needed (OR, ICU, ER, or as part of Rapid Sequence Intubation kits). They should not be stored in floor stock or ADC’s on other units.
References:
ISMP (Institute for Safe Medication Practices). Your attention please… Designing effective warnings. ISMP Medication Safety Alert! Acute Care Edition 2019. February 28, 2019
https://www.ismp.org/resources/your-attention-please-designing-effective-warnings-0
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