Exclusive to The Medication Safety Board is a risk assessment service that evaluates a unique aspect of a product, such as a container label issue, a dosage form, special packaging requirements, or product interface with medication-related technology. 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).