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.
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
- FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)
- FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved
- FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam)
- FDA Drug Safety Communication: FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam)
- FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients
- FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death
- FDA Drug Safety Communication: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)
ISMP FDA Advise-ERR Articles
- FDA Advise-ERR: Pen injectors need pen needles
- FDA Advise-ERR: Reported Medication Errors with Veklury (Remdesivir) Emergency Use Authorization
- FDA Advise-ERR: Taking Crysvita with active vitamin D analogs is contraindicated
- FDA Advise-ERR: Covers still being applied without the clonidine patch
- FDA Advise-ERR: Lumoxiti has unique preparation instructions!
- FDA Advise-ERR: Vyxeos: Verify Drug Name and Dose to Avoid Errors!
- FDA Advise-ERR: Concomitant use of Entresto and ACE inhibitors can lead to serious outcomes
- FDA Advise-ERR: Veterinary Drug and Human Drug â A Drug Name Mix-up
Campaign to Eliminate Use of Error-Prone Abbreviations
- ISMP List of Error-Prone Abbreviations, Symbols, and Dose Designations
- Facts about the Joint Commission's Do Not Use List of Abbreviations
Resources For You
- Agency for Healthcare Research and Quality: Medical Errors
- Centers for Disease Control and Prevention: Medication Safety
- Department of Veterans Affairs National Center for Patient Safety
- Institute for Safe Medication Practices
- National Patient Safety Foundation Institute for Healthcare Improvement
- To Err is Human: Building a Safer Health System (Institute of Medicine)
- Preventing Medication Errors: Quality Chasm Series (Institute of Medicine)
- National Coordinating Council for Medication Error Reporting and Prevention
- Report medication errors to FDA Medwatch
- From our perspective: Working to prevent proprietary drug name confusion
- Computerized Prescriber Order Entry Medication Safety (CPOEMS)
- Update on Phonetic and Orthographic Computer Analysis Tool
- ISMP's List of Error-Prone Abbreviations, Symbols, and Dose Designations
- FDA Drug Info Rounds Video: Medication Errors
- FDA List of Established Drug Names Recommended to Use Tall Man Lettering
- Over-the-Counter (OTC) Dosage Delivery Devices
- Avoiding Medication Mistakes