By ClinSmart on Nov 29, 2017 9:00:00 AM
The integrity and safety of a clinical trial greatly depends on adherence to the carefully considered and approved administration protocol for a new investigational drug. Medication errors rarely are the fault of the individual, yet are a consequence of inappropriate naming and labeling of new drugs. Specifically, it has been shown that eliminating look-alike and sound-alike names and removing ambiguous naming conventions greatly decreased medication errors. Historically, design issues with new drug products were not identified and resolved until post marketing surveillance activities or in some cases, when medication errors reached and harmed patients. So now, the FDA is driving the implementation of well-defined naming and labelling strategies that can be used by the companies before the product gets in the hand of the user.
One of the first steps a company can take before sending in a new drug application to the FDA, is evaluate how and why problems have occurred with similar products and eliminate them from your product’s naming and labeling design. Below are some quick suggestions that you team may want to consider as well.
Naming Consideration Tips
- Perform a preliminary screening to see if your drug is obviously like another one on the market. Things to look for include similar spelling or similar pronunciation of the names.
- Names that begin and end with the same letter tend to get confused a lot so try to avoid that.
- Do not include a name in which a medical abbreviation is incorporated. For example, Macrobid where BID is the medical abbreviation for ‘twice daily’.
- Ensure that the name is not the same as a discontinued product.
Labelling Consideration Tips
- Understand how your drug will be stored to eliminate look alike labels. In storage settings, it is very easy to mix up drug products if labels are the same color and/or design.
- Design the label so visual clutter is at a minimum to ensure that important information (ie. a warning) is read.
- Use positive statements instead of negative. In other words, do not use the word ‘NOT’ because it may be overlooked. Indicate ‘For IV use only’, instead of ‘NOT for intrathecal use’.
- Warnings should consider how the patient (in most cases a lay person) and medical professional may interpret the warnings.
Perform a simulated use testing
Once you have the name and label confirmed, it’s important to perform a simulated test and consider all environments of use throughout the entire process (prescription from doctor, storage in facility, pharmacist handling, administration at home or in the clinic). These tests seek to assess actual use in realistic situations and determine whether all users can safely and correctly perform their critical tasks.
There are consistently new drugs coming on the market so deriving a unique name and label is no easy task. But if you start with these tips and discuss with your FDA representative, collectively, you’ll find an appropriate solution that will eliminate medication errors and ensure the integrity of your clinical trials.