Ensure Patient Safety When Naming Biological Medications
May 23, 2014
By David Charles, MD and Mary Ann Chapman, PhD
If requiring biological medications to have unique names would help ensure patient safety, wouldn’t it be an important convention to implement? The United States Food and Drug Administration (FDA) and several other organizations are currently considering requirements for naming biological medications—those often produced from cells or living organisms. Te question is whether biological medications that are similar to one another should have similar nonproprietary names (that is, non-brand names), or whether their names should be identical.
In making this determination, it is critical to recognize that the variations among biological medications can sometimes lead to differences in side effects or immune responses in a given patient. In such cases, physicians must be able to identify exactly which medication caused the reaction so that it can be properly documented and reported, and patients can be switched to a different medication. Only if biological medications have distinct non-proprietary names can the correct medication be identified definitively, quickly, and easily. Thus, to promote patient safety, it is essential that similar biological medications have unique non-proprietary names.Biologics, Regulatory Issues
Categorized in: Policy Briefs, Policy Papers