Failure Mode Effects Analysis (FMEA)
Conducting an FMEA can identify opportunities for labeling-related errors. The FMEA should address each step of the process that is impacted by labeling. Begin by observing compounding personnel in the cleanroom. Identify each point in their workflow where a problem could develop. This observation process should span different shifts and staff members to determine procedural consistency.
In addition, observe the stocking and picking processes in action to determine where a mistake is likely to occur. Watch for every step that requires your staff to make a decision as this provides the opportunity for human error to occur. Pay particular attention to:
- Drugs that are labeled with similar colors
- Look-alike, sound-alike drugs
- Clutter in the storage and dispensing areas
- The potential for drugs to fall from one bin into another
- The effects of high-volume periods on the pharmacy staff
- Workflow where multiple products occupy the same work space1
1. Lesar TS. IV product labeling. Pharm Purch Prod. 2008;1:2-4.
Optimal Label Components
- Include sufficient white space to promote readability
- Test label readability with a matte versus a glossy finish
- Use the largest font size possible: 12-point type is recommended
- Use fonts with proportional spacing rather than fixed-width spacing
- Ensure that the USP guidelines for standardizing abbreviations are implemented consistently
- For doses that will be administered via smart pump, ensure that the label information is presented to match the order by which the user programs the pump. Should your facility change smart pump vendors, check that workflow required for the new equipment is reflected in the order of information on the label
- Always spell out ‘units’, as ‘U’ can be mistaken for a zero and result in a 10-fold overdose
- Do not permit the use of slashes or hyphens within your labels as these can easily be misinterpreted as the number one and result in an administration error
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