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Medication Errors Related to CDER-Regulated Drug Products

The Division of Medication Error Prevention and Analysis (DMEPA) and Division of Mitigation Assessment and Medication Error Surveillance (DMAMES) within FDA’s Center for Drug Evaluation and Research (CDER), Office of Medication Error Prevention and Risk Management (OMEPRM) are responsible for monitoring and preventing medication errors related to the naming, labeling, packaging, and design for CDER-regulated drug and biological products.

The National Coordinating Council for Medication Error Prevention and Analysis (NCC MERP) 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. 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 receiving a wrong drug because of look-alike container labels is a preventable event. The development of anaphylaxis in a patient with no previous history of allergies after taking a sulfa drug is not considered preventable. A medication error may or may not result in an adverse event.

DMEPA and DMAMES have multidisciplinary teams 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 postapproval.

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.

Postapproval, DMEPA and DMAMES collaborate to monitor and analyze 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 to FDA’s Adverse Event Reporting System (FAERS) is voluntary in the United States, though FDA encourages healthcare providers, patients, consumers, and manufacturers to report medication errors, 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 and DMAMES also collaborate 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.

DMEPA and DMAMES also meet with federal partners, including the VA National Center for Patient Safety, to share information (e.g., best practices, front line experience, research, training) that inform medication error prevention and analysis.


FDA Guidance for Industry

We update guidances periodically. For the most recent version of a guidance, see FDA’s website on guidance documents.

FDA guidance for industry, Contents of a Complete Submission for the Evaluation of Proprietary Names (April 2016).

FDA  guidance for industry, Best Practices in Developing Proprietary Names for Human Prescription Drug Products (December 2020).

FDA draft guidance for industry, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products (December 2020).  When final, this guidance will represent FDA’s current thinking on this topic.

FDA draft guidance for industry, Nonproprietary Naming of Biological Products: Update (March 2019).  When final, this guidance will represent FDA’s current thinking on this topic.

FDA guidance for industry, Safety Considerations for Product Design to Minimize Medication Errors. April 2016.

FDA guidance for industry, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. May 2022.

FDA draft guidance for industry, Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications (September 2018). When final, this guidance will represent FDA’s current thinking on this topic.

FDA draft guidance for industry, and Food and Drug Administration staff, Applying Human Factors and Usability Engineering to Medical Devices (February 2016). When final, this guidance will represent FDA’s current thinking on this topic

FDA PDUFA Pilot Project: Proprietary Name Review Concept Paper (September 2008).

FDA Drug Safety Communications for Drug Products Associated with Medication Errors

ISMP FDA Advise-ERR Articles

Campaign to Eliminate Use of Error-Prone Abbreviations

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