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Medication Errors Related to CDER-Regulated Drug Products

Mission: Increase the safe use of drug products by minimizing use error related to the naming, labeling, packaging, or design of drug products regulated by the Center for Drug Evaluation and Research (CDER).

Vision: To eliminate medication errors in the U.S. healthcare system.

The Division of Medication Error Prevention and Analysis (DMEPA) within CDER is responsible for monitoring and preventing medication errors related to the naming, labeling, packaging, and design for CDER-regulated drugs and therapeutic biological products.

FDA defines a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a healthcare provider, patient, or consumer.  This definition is based on the one stated by the National Coordinating Council for Medication Error Reporting and Prevention1,  The deliberate or intentional use (e.g., abuse, misuse, off label use) of a drug product in a manner that is inconsistent with FDA-required labeling isn’t generally considered a medication error. A “preventable event” refers to events that are due to errors that could be avoided. For example, a patient who receives a wrong drug because of look-alike container labels is a preventable event. A patient with no previous history of allergies who experiences anaphylaxis after taking a sulfa drug is not considered preventable. A medication error may or may not result in an adverse event.

DMEPA has a multidisciplinary staff of safety analysts who receive specialized training in the regulatory review and analysis of medication errors, and provide expertise within FDA and to external organizations to assess the risk of medication errors throughout a product’s lifecycle, from preapproval to postmarket.

As part of the FDA preapproval process for new drug products, DMEPA reviews, and determines the acceptability of proposed proprietary names to minimize medication errors associated with product name confusion.  DMEPA also reviews proposed container labels, carton labeling, prescribing information (including the Instructions for Use and Medication Guides), packaging, product design, and human factors protocols and study results to minimize or eliminate hazards that can contribute to medication errors.  DMEPA also provides guidance for manufacturers to consider when naming and designing their drug products.2,3,4,5

DMEPA monitors and analyzes medication error reports associated with marketed drug products, including over-the-counter (OTC), prescription, generics, and biosimilars and other therapeutic biologicals.  The reporting of medication errors is voluntary in the United States, but DMEPA encourages healthcare providers, patients, consumers, and manufacturers to report medication errors to FDA, including circumstances such as look-alike container labels or confusing prescribing information that may cause or lead to a medication error.  Depending on the type of error, root cause, contributing factors, and safety risks for a reported medication error, FDA may take regulatory action such as revising the labeling or issuing a safety communication to help prevent errors. In some cases, FDA may consider a change to the proprietary name to address safety issues resulting from name confusion errors.

DMEPA also collaborates with external stakeholders, regulators, patient safety organizations such as the Institute for Safe Medication Practices (ISMP), standard setting organizations such as the United States Pharmacopeia (USP), and researchers to understand the causes of medication errors, the effectiveness of interventions to prevent them, and address broader safety issues that contribute to medication errors.

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1 Our definition is based on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) definition and taxonomy for medication errors.  Available from https://www.nccmerp.org/.  [cited May 2018].
2 FDA guidance for industry Contents of a Complete Submission for the Evaluation of Proprietary Names. We update guidances periodically.  For the most recent version of a guidance, see FDA’s website on guidance documents (available from https//www.fda.gov/RegulatoryInformation/Guidances/default.htm).
3  FDA draft guidance for industry Best Practices in Developing Proprietary Names for Drugs.  When final, this guidance will represent FDA’s current thinking on this topic.
4 FDA guidance for industry Safety Considerations for Product Design to Minimize Medication Errors.
5 FDA draft guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. When final, this guidance will represent FDA’s current thinking on this topic.

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