Premarket Screening

Screening of new packaging and labeling prior to submission to regulatory authorities

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One of the most common concerns expressed by those who report medication errors to the ISMP National Medication Errors Reporting Program (ISMP MERP) is related to actual and potential errors involving product container labels. For example, ISMP receives multiple complaints each week about look-alike product labeling; confusing, misleading, or missing information on container labels; and issues involving labels that do not fully comply with USP <7> or the US Food and Drug Administration (FDA) guidance statements. These situations can and do lead to patient harm and even death.

During product development, companies can rely on The Medication Safety Board to screen proposed packaging and labeling against products that are already in the marketplace in order to identify any potential look-alike issues. The Medication Safety Board also provides review of product packaging and labeling to ensure consistency with current safety and regulatory standards and requirements, prior to submission to regulatory authorities. The Medication Safety Board uses internal experts as well as its network of clinical and medication safety practitioners to identify potential risks for product confusion and opportunities for design improvement. No other organization has the level of expertise in this area due to our relationship with ISMP and our regular review of reported errors and safety issues.