Safe Medication Use 75F40125Q00401

Background The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) is interested in obtaining products, services, and access to medication error[1] data collected from across the United States to inform regulatory and mission critical surveillance activities. FDA considers risks from medication errors in its overall assessment of drug safety. For example, regulatory actions to minimize medication error risks include requiring a boxed warning in the Prescribing Information to prevent dosing errors, changing a proprietary name to prevent wrong drug errors, and revising container labels to prevent wrong route of administration errors.[2],[3],[4] As the FDA continues assessing adverse events associated with the use of drug products in the postmarketing setting, FDA seeks to enhance data coverage through available products, services, and access to medication error data associated with FDA regulated drug products that is gathered nationwide from healthcare providers, consumers, patient safety organizations, published literature, and other sources of safety information. Objectives FDA s objective is to acquire: Medication error case reports collected from across the U.S. population (including pediatrics and adults) throughout the medication use process[5] with sufficient granularity to understand the type of error, where the error originated, specific product(s) involved in the error, causes or contributing factors for the error, actions taken or recommended to prevent the error from occurring, adverse events and outcomes associated with the error. Unlimited, multi-user access to medication error data from an existing web-based analytics platform[6] that contains at least 5 years of medication error case reports from across the United States to support surveillance activities for identifying and tracking medication error safety related issues. Medication error data to inform appropriate responses to emerging public health safety concerns to ensure the safety of FDA-regulated drug products. Advanced subject matter expertise, training, and education to increase existing knowledge and experience within FDA on medication error prevention and analysis, including medication error risks, incidence trends, causes, and mitigation strategies.

Amendment 1: The purpose of this amendment is to provide the answers to questions received. -------------------------------------------------------------------------------------------------------------------------------- Background The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) is interested in obtaining products, services, and access to medication error[1] data collected from across the United States to inform regulatory and mission critical surveillance activities. FDA considers risks from medication errors in its overall assessment of drug safety. For example, regulatory actions to minimize medication error risks include requiring a boxed warning in the Prescribing Information to prevent dosing errors, changing a proprietary name to prevent wrong drug errors, and revising container labels to prevent wrong route of administration errors.[2],[3],[4] As the FDA continues assessing adverse events associated with the use of drug products in the postmarketing setting, FDA seeks to enhance data coverage through available products, services, and access to medication error data associated with FDA regulated drug products that is gathered nationwide from healthcare providers, consumers, patient safety organizations, published literature, and other sources of safety information. Objectives FDA s objective is to acquire: Medication error case reports collected from across the U.S. population (including pediatrics and adults) throughout the medication use process[5] with sufficient granularity to understand the type of error, where the error originated, specific product(s) involved in the error, causes or contributing factors for the error, actions taken or recommended to prevent the error from occurring, adverse events and outcomes associated with the error. Unlimited, multi-user access to medication error data from an existing web-based analytics platform[6] that contains at least 5 years of medication error case reports from across the United States to support surveillance activities for identifying and tracking medication error safety related issues. Medication error data to inform appropriate responses to emerging public health safety concerns to ensure the safety of FDA-regulated drug products. Advanced subject matter expertise, training, and education to increase existing knowledge and experience within FDA on medication error prevention and analysis, including medication error risks, incidence trends, causes, and mitigation strategies.