VIV Podcast

Drug Naming and Medication Errors

A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it’s look alike or sound alike errors, drug modifier misidentification, or proprietary vs. non-proprietary names, confusion may lead to medication errors – which of course can have fatal effects on patients and consumers. Listen as we chat with Karen Zimm and Paul Pluta on the particulars of the drug naming process, definitions, and categories for drug names, highlighting case study scenarios where drug name communications have led to adverse events. 

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Resources for this Episode:

Articles:

  1. Medication Safety: Industry Considerations Part 1 - Problem Overview
  2. Regulatory 101: Medication Safety - Industry Considerations, Part 2, Drug Names
  3. Regulatory 101: Drug Name Modifiers – Definition, Categories, Generics, And CAPA
  4. Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology And Format
  5. Medication Safety And Drug Names - Valproic Acid Product Problems

References:

  1. FDA.  Guidance for Industry.  Best Practices in Developing Proprietary Names for Drugs. 
  2. FDA.  Contents of a Complete Submission for the Evaluation of Proprietary Names. 
  3. FDA.  Safety Considerations for Product Design to Minimize Medication Errors. 
  4. FDA. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.  
  5. Medicines & Healthcare products Regulatory Agency (UK MHRA).  MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label. 
  6. European Medicines Agency (EMA).  Guideline on the acceptability of names for human medicinal products processed through the centralized  procedure.
  7. Health Canada.  Guidance Document for Industry.  Review of Drug Brand Names.  
  8. Health Product Regulatory Authority (Ireland).  Guide to Invented Names of Human Medicines.  
  9. To Err is Human:  Building a Safer Health System.  Institute of Medicine, National Academic Press, Washington, DC, 2000. 
  10. Preventing Medication Errors.  Institute of Medicine.  National Academic Press., Washington, DC, 2007.

 




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