Guidelines to Reduce Drug Name Confusion and Medication Errors

At the time the NEJM correspondence was published, the FDA did not have draft guidance on drug naming regarding safe practices. The response from the FDA was based on experience and protocol. However, because confusing drug names can have a serious impact on a patient’s life, the FDA and governmental organizations issued guidance on drug naming in an effort to prevent medication errors.4 “We put out guidance in this area in late May that outlines all considerations when reviewing drug names. We look at a plethora of things, including similarity to other drug names. We look at each name in a specified way. We have a specialized tool, called POCA, which is a tool that assesses similarity scores with other names on the market. In addition, we conduct further analysis to identify whether other items could lead to drug name confusion,” said Taylor.

Conclusion

Overall, it is important to report any instances of drug name confusion to the FDA. “This is something the FDA will evaluate and address on an ongoing basis. It is important for the FDA to do root cause analysis and apply experiences to the next name going through the approval system, so we don’t perpetuate the problem,” said Taylor.

References:

  1. Institute for Safe Medication Practices. Similar Drug Names Confused. Available at: https://www.ismp.org/newsletters/ambulatory/showarticle.aspx?id=7. Accessed: July 22, 2014.
  2. Garick, MB. Possible Confusion in Names of New Treatments for Prostate Cancer. N Engl J Med. 2013 (368): 194.
  3. Taylor KA. More on Confusion of Drug Names. N Engl J Med. 2013 (368): 1946-1947.
  4. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs. Available at: www.fda.gov. Accessed: July 22, 2014.