Package and Label Evaluation

The Med-E.R.R.S. staff uses the experience we've gained through interactions with other companies, as well as our knowledge of medication error causality, to perform expert reviews of drug product packaging and labels. Our findings help clients create packaging and labels that are easy to understand and consistent with the most current FDA regulations. Our overall goal is to reduce the risk of error in whatever clinical setting the product is used.

We collaborate with the client to obtain background information about the product and to discuss the proposed packaging and label. We then apply various tools and techniques to "error-proof" the written and associated graphic information on medication cartons, ampuls, vials, syringes, and other drug-related materials and tools. Included in our review is consideration of the clinical environment in which the product will be used. Enlisting the aid of our pharmacy and nursing consultants in clinical practice, we consider such factors as:

• overall appearance of the label
  
• readability and placement of the product name and information
  
• presence of confusing terminology, abbreviations, and other extraneous information; and
  
• visibility and positioning of important information.
  

Once we analyze the data, we submit an executive summary to the client with our recommendations.