Exclusive to Med-ERRS, EVALUATE-ERR® is a risk assessment service that assesses a unique aspect of a product, such as a dosage form, special packaging, or trademark. 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 EVALUATE-ERR® service can help you with medication safety issues include:
- Change in presentation of a product (e.g., vial to pre-filled syringe)
- Nomenclature strategy for a product line extension or new indication (e.g., use of modifier or new trademark)
- Non-proprietary name evaluation
- Determining appropriate co-packaging
- Best dosage expression (strength, form, schedule or formulation)
- End-user (practitioner or patient) instructions for use (IFU)
Companies can employ the EVALUATE-ERR® service for internal use, or be asked by the FDA to provide a risk assessment related to their product. In their guidance, the 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).
Safety Issue: Family Tradenames