Volume 6, Issue 1 UPDATE-ERR™ Winter 2013
President's Message

Dear Friends and Colleagues:

Happy New Year!

We are pleased to report that, amid the holiday rush, FDA released the first of three draft guidances that relate to medication safety. The draft guidance entitled, "Safety Considerations for Product Design To Minimize Medication Errors," focuses on the utility of performing proactive risk-assessments in the early stages of pharmaceutical product design. Over the past several years, Med-ERRS has become more involved with providing this type of service in advance of the performance of testing with proposed end users.

See below for links to the Federal Register notice and the draft guidance, which is open for public comment. Please contact us for more information on how Med-ERRS can help you with your product risk-assessment needs.

We eagerly await the release of the other two medication safety-related guidances which will focus on labels and packaging and nomenclature, although no schedule for their release has been announced.

As always, please contact us directly if you would like our schedule or would like to discuss any of our services.

Best wishes for a prosperous 2013.


In the News

FDA announces draft guidance, "Safety Considerations for Product Design To Minimize Medication Errors"

Federal Register announcement; Draft Guidance

FDA approves 35 new chemical entities in fiscal year 2012

News from the ISMP Medication Safety Alert! Newsletter (November 15, 2012)

ISMP announces launch of third error reporting program

ISMP launched its third national patient safety reporting program. The ISMP National Vaccine Errors Reporting Program (ISMP VERP) joins the National Medication Errors Reporting Program (ISMP MERP) and the Consumer Medication Errors Reporting Program (C-MERP). VERP ( captures the unique causes and consequences of vaccine-related errors. The program was designed with the assistance of the California Department of Public Health. As with all ISMP reporting programs, reporter information is confidential. Reports to VERP will be sent to the US Food and Drug Administration and the Centers for Disease Control and Prevention.

Med-ERRS Services

  • Trademark Evaluation : Med-ERRS has developed a service for evaluating the safety of trademarks called the ERRS MODEL ® , which incorporates various techniques recommended by the FDA to evaluate the safety of trademarks.
  • SCREEN-ERR : Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.
  • Package and Label Evaluation : Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and world wide regulatory authorities.
  • Safety Consulting : Provides consultative services which are related to a variety of medication safety-related issues.

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