MedWatch reporting

  • PTCB PTCE
  • Patient Safety and Quality Assurance
  • Multiple choice
  • Difficulty 3 of 5

Question

A pharmacy technician identifies a medication error involving a confusing drug name and informs the pharmacist. Which FDA program can receive a report of the error?

  1. MedWatch✓ Correct

    FDA identifies MedWatch as a route for reporting medication errors.

  2. REMS@FDA✗ Incorrect

    REMS materials describe medication-specific safety programs, rather than serving as the cited error-reporting route.

  3. A recall classification✗ Incorrect

    A recall class describes a product hazard, not the reporting program.

  4. Tall-man lettering✗ Incorrect

    Lettering distinguishes names; it is not a reporting program.

Answer

A. MedWatch

Rationale

FDA encourages reports when drug names contribute to errors. MedWatch is a route for reporting those events to FDA.

RememberReport medication errors to FDA through MedWatch.

Sources

  • Drug Name Review U.S. Food and Drug Administration · License: US government work (public domain) · Retrieved · Video Transcript · page updated Thu, 03/03
  • What's in a REMS? U.S. Food and Drug Administration · License: US government work (public domain) · Retrieved · Current REMS · page updated Fri, 01/26
  • FDA Name Differentiation Project U.S. Food and Drug Administration · License: US government work (public domain) · Retrieved · FDA List of Established Drug Names Recommended to Use Tall Man Lettering (TML) · page updated Fri, 06/12
  • Medication Errors: U.S. Food and Drug Administration · License: US government work (public domain) · Retrieved · Page 43

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