News & Info

Medication errors involving drug names that may look or sound similar to one another have become a prominent issue worldwide.  As such, regulatory authorities are beginning to require sponsors to perform safety testing of trademarks prior to the drug being approved.

Below are the links to the various health authorities’ guidances:

• The Health Canada guidance became effective January 1, 2006.
• The EMEA guidance is currently being revised and is scheduled to be finalized in July 2007. 
• While no formal guidance is expected from FDA for several more years, the “Guidance for Industry, Premarketing Risk Assessment” does contain some information regarding Assessing and Minimizing the Potential for Medication Errors. 
• Also, as of May 2007, The World Health Organization, in collaboration with The Joint Commission International has released a statement on “Nine Life-Saving Patient Safety Solutions,” one of which addresses look-alike and sound-alike medication names.

Contact Med-E.R.R.S. for more information on how we can help you fulfill the requirements outlined in the guidances

Below are links to additional news releases and information related to medication safety and error prevention.

To arrange interviews, email Renee Brehio (Public Relations) or call her at 704-831-8822.

• On March 7, 2007, Med-E.R.R.S. and the law firm of Dorsey & Whitney held a seminar entitled Pharmaceutical Branding: Trademark Registration and FDA Regulatory and Safety Issues 

  Designed for professionals working in the areas of pharmaceutical trademark development, the seminar discussed the processes used by the FDA and the USPTO to evaluate and approve (register) trademarks, with a focus on avoiding confusability among drug names.  For a copy of the slide presentations, please contact info@med-errs.com .

• Med-E.R.R.S. announces a new collaboration called PhyVe (02/2007)
• View the agenda and presentations from the joint FDA, ISMP and USP meeting entitled: “Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products.” (01/2007)
  
  

  Meeting URL: http://www.fda.gov/cder/meeting/parenteral_labeling.htm
  Presentations URL: http://www.fda.gov/cder/meeting/parenteral/presentations.htm

• Pharmaceutical trademarks used in one country for a product may represent a different active ingredient in another country.  Click here for more information. (5/2006)
• OTC brand name line extensions can cause errors. Click here for more information (5/2007)
• Listen to the recording of the John Gormley live radio interview on medical errors (11/2006)
• Med-E.R.R.S. Announces New Board Members (2/2006)

Past Articles From the ISMP Medication Safety Alert!