Risk Assessment Services

Exclusive to The Medication Safety Board, EVALUATE-ERR® is a risk assessment service that is used to assess a unique aspect of a product, such as a container label issue, change in product packaging or presentation, special packaging requirements, or product interface with medication-related technology, in order to identify areas of vulnerability and to help mitigate risks. We employ Failure Mode and Effects Analysis (FMEA) to determine which path or choice to follow to minimize the risk of error and provide specific recommendations and error-reduction strategies.

Examples of how the risk assessment service can help you with medication safety issues include:

• Change in presentation of a product (e.g., vial to prefilled syringe)
• Determining appropriate co-packaging
• Best expression of product information (e.g., strength, form, schedule, formulation)
• End-user (i.e., practitioner or patient) instructions for use (IFU)

Companies may proactively choose to use our risk assessment services, or be asked by a regulator to provide a risk assessment related to their product. For example, the US Food and Drug Administration (FDA) recommends that companies who are developing a new preparation of an already-marketed product perform a risk assessment using Failure Mode and Effects Analysis (FMEA).