This week, Stacey is joined by Paul Pluta and Karen Zimm to discuss the particulars of the drug naming process, definitions, and categories for drug names. Karen and Paul present case study scenarios where drug name communications have led to adverse events. 

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.

Resources for this Episode:


  1. Medication Safety: Industry Considerations Part 1 - Problem Overview 

Regulatory 101: Medication Safety - Industry Considerations, Part 2, Drug Names

Regulatory 101: Drug Name Modifiers – Definition, Categories, Generics, And CAPA

Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology And Format 

Medication Safety And Drug Names - Valproic Acid Product Problems


  1. FDA.  Guidance for Industry.  Best Practices in Developing Proprietary Names for Drugs. 

FDA.  Contents of a Complete Submission for the Evaluation of Proprietary Names. 

FDA.  Safety Considerations for Product Design to Minimize Medication Errors. 

FDA. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. 

Medicines & Healthcare products Regulatory Agency (UK MHRA).  MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label.

European Medicines Agency (EMA).  Guideline on the acceptability of names for human medicinal products processed through the centralized  procedure.

Health Canada.  Guidance Document for Industry.  Review of Drug Brand Names.

Health Product Regulatory Authority (Ireland).  Guide to Invented Names of Human Medicines.  file:///D:/HPRA%20Drug%20names.pdf

To Err is Human:  Building a Safer Health System.  Institute of Medicine, National Academic Press, Washington, DC, 2000. 

Preventing Medication Errors.  Institute of Medicine.  National Academic Press., Washington, DC, 2007. 

Karen R. Zimm, Ph.D. 

Karen is currently an Associate Director in Global Regulatory Affairs for Johnson & Johnson Pharmaceutical Research and Development with responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in technical operations with Pharmaceutical Sourcing Group – Americas, a division of Ortho-McNeil Pharmaceutical and research & development for the R.W. Johnson Pharmaceutical Research Institute and Whitehall Robins Healthcare (Wyeth Consumer Products). She earned her Bachelor of Science in Pharmacy and PhD in Pharmaceutics under Dr Joseph Schwartz from the Philadelphia College of Pharmacy and Science, MBA in Pharmaceutical Management from Drexel University, and the MS in Quality Assurance/Regulatory Affairs from Temple University. In addition she is a licensed pharmacist and an adjunct professor for the School of Pharmacy/Quality Assurance-Regulatory Affairs at Temple University in Philadelphia, PA.

Paul L. Pluta, Ph.D.

Paul is a pharmaceutical scientist with technical development, manufacturing, and management experience. He has been involved in nearly all phases of pharmaceutical development and manufacturing including R&D formulation and process development, dissolution, stability, regulatory, quality assurance/control, compliance, specifications, scale-up, technology transfer, technical support, and validation/qualification. In his time at Abbott he had numerous new product and supporting regulatory submissions, as well as, extensive product technical support experience. Additionally, his validation experience includes manufacturing process validation, cleaning validation, and associated systems qualification including aseptic systems. He was also a practicing pharmacist for many years in community and hospital environments with direct involvement in preventing medication errors. He may be reached at [email protected].

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