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Volume 7, Issue 4 UPDATE-ERR Fall 2014

 

President's Message

Dear Friends and Colleagues:

Last month, FDA established a public docket, to discuss with industry, issues related to reserving proprietary names for drug products. FDA and industry stakeholders have expressed interest in the past with exploring the possibility of ‘‘reserving’’ proprietary names for companies once the names have been tentatively accepted by the Agency. 

Eliminating “tentative approvals” and instead permitting “name reservations” early in the approval process would hopefully provide sponsors with initial clarity and confidence in moving forward to the final stages of product development and marketing.

FDA invites comments on all matters related to a potential program for reserving names for drug products and is particularly interested in obtaining feedback and details from industry. Below is a list of some, but not all, of the matters they are asking for input on:

  • Examples of drug market launches being delayed, the length of the delay and drugs launched without a proprietary name due to name rejection by the FDA 
  • Potential approaches for reserving proprietary names that would create more “certainty” for applicants than the current tentative acceptance
  • How the program would create certainty while balancing/minimizing risks of medication errors
  • Parameters that would be necessary – voluntary vs. mandatory
  • The number of applicants that would be interested in participating in a “voluntary name reservation program”
  • What mechanisms can be used to provide notice to an applicant of possible confusion between its proposed brand name and other proposed brand names in pending applications

The docket will be open for public comments until October 27, 2014. Please click here to view the docket and submit your comments. Med-ERRS highly encourages our industry clients and colleagues to submit their experiences and comments to the docket. We will be submitting our feedback later this month.

If you have any questions regarding the docket, please visit the FDA website at www.fda.gov.

Warm regards, 

Susan


 
In the News

 Upcoming Conferences:

PTMG 2014 Fall Meeting in Chicago

Med-ERRS will attend this year's Fall PTMG conference in Chicago in early October. We are particularly excited to hear Kellie Taylor's perspectives and updates on the recent developments in FDA’s review of proprietary names for pharmaceuticals.

For those who are attending the conference and are interested in meeting with us, please email Diane Bernstein at dbernstein@med-errs.com.


Relevant Safety Issues from ISMP's Medication Safety Alert!® Newsletter

TraZODONE and traMADOL bottles look alike

A pharmacist recently alerted us to the look-alike bottles of traZODONE and traMADOL from Teva (Figure 1). The pharmacist indicated that she has intercepted errors involving these products before they reached the patient. Both products share multiple characteristics that contribute to the problem, including: 1) look-alike names; 2) same dosage strength; 3) same color scheme used for the dosage strength, tablet count, and manufacturer name; 4) same color used for the bottle caps; and 5) the products may be stored near one another on pharmacy shelves. ISMP has notified the US FDA and has asked Teva to take steps to change the packaging of these products. 

Key Takeaway: It is crucial for sponsors to evaluate their product's name in combination with its product packaging and design to minimize the chance of medication errors occurring. 


ISMP Medication Safety Alert®, Community/Ambulatory Care: Volume 13, Issue 7


 Our Services 
  • NEW!PREVIEW-ERRsm: This service is used to rapidly eliminate unacceptable trademark candidates from client's lists of trademark candidates by providing preliminary, top-of-mind, expert healthcare professional opinions and reactions to proposed names before any trademark searching or testing has been completed.
  • SCREEN-ERR®: Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.
  • ERRS MODEL®: Med-ERRS has developed this service for evaluating the safety of trademarks. ERRS MODEL incorporates various techniques recommended by the FDA to proactively help prevent medication errors by testing for potential look-alike and sound-alike confusion with proposed trademarks.
  • EVALUATE-ERR®: A safety consulting service that examines a unique aspect of a product (such as a dosage form, special packaging, or trademark) and its vulnerability to user error.
  • Package and Label Evaluation: Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and worldwide regulatory authorities.
  • Safety Consulting: Provides consultative services which are related to a variety of medication safety-related issues.

 

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