Close

Volume 7, Issue 3 UPDATE-ERR Summer 2014

 

President's Message

Dear Friends and Colleagues:

After many years of anticipation, last month the FDA finally released their long-awaited draft guidance outlining its recommended best practices for trademark name development titled, “Best Practices in Developing Proprietary Names for Drugs.” 

Industry has been encouraged to submit comments to the docket until the July 28 deadline. Med-ERRS is in the process of putting together comments that we will submit in the coming weeks which will reflect our constructive suggestions for improvement to the new guidance. In addition, we've already started developing a new process to use with our clients to satisfy the new recommendations contained in the document. If you have questions or would like to learn more about the new guidance, feel free to:

  • Reach out to the Med-ERRS team directly at anytime (info@med-errs.com or 215-947-8306)
  • Listen to the upcoming FDAnews webinar on the new FDA draft guidance (July 22, 2014, registration details below)
  • Listen to the upcoming webinar on the new FDA trademark draft guidance hosted by Deputy Director, Kellie Taylor, PharmD, M.Ph. (July 15, 2014 at 11:00 am EST, please click here)

 

Med-ERRS is also excited to announce that we recently expanded our trademark service portfolio by adding a brand new offering called PREVIEW-ERRsm.

PREVIEW-ERR is a “knock-out” trademark service that we use to evaluate multiple pharmaceutical trademark candidates in the very early stages in the trademark development process. It quickly eliminates unacceptable trademarks candidates from lists of proposed trademark candidates to obtain preliminary, top-of-mind, expert healthcare professional opinions and reactions to proposed names. 

This new service is not intended to be a legal screening, a trademark search or to replace trademark confusability testing. Instead, it is designed to assist clients with quickly obtaining a snapshot of the overall potential viability of proposed names before conducting more involved and more time intensive trademark searching or testing.

Med-ERRS can review a list of 25-50 proposed brand names and provide feedback using PREVIEW-ERR in no more than 48 hours.

To learn more about PREVIEW-ERR, please reach out to us directly or click here.

Warm regards, 

Susan


 
In the News

 Upcoming FDAnews Webinar

Choosing the Right Drug Name: How to Increase Your Chances for Approval 

Med-ERRS President, Susan Proulx, PharmD, has teamed up with FDAnews to present a 90-minute webinar  titled, "Choosing the Right Drug Name: How to Increase Your Chances for Approval". The webinar will look closely at the recently released FDA proprietary name development draft guidance and its recommended 4-step process. 

The webinar is planned for July 22, 2014 from 1:30-3:00 pm EST.

To register for this webinar please visit: www.fdanews.com/rightdrugname or click here.


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

Dosing Error with Tasigna

Patient confusion may lead to dosing errors with TASIGNA (nilotinib) due to pre-printed dosing instructions on the manufacturer's packaging that reflect only the usual recommended starting doses. A patient with chronic myeloid leukemia (CML) was prescribed Tasigna 150 mg with instructions to take 2 capsules (300 mg) twice daily, the recommended starting dose for newly diagnosed CML. Product labeling for Tasigna includes a boxed warning about QT prolongation and sudden death. After several weeks on this new medication, the patient developed QT prolongation.

After this was discovered, the patient's physician followed the manufacturer's label recommendation which state if clinically significant moderate or severe non-hematologic toxicity develops, providers should withhold the medication then resume at 400 mg ONCE daily when the toxicity has resolved. The patient was instructed to hold the medication for 2 weeks and then undergo further clinical evaluation.

After the QT prolongation resolved, a new Tasigna prescription was provided for a reduced dose of 400 mg once daily. The patient filled the prescription, and the pharmacy provided 200 mg capsules in a blister pack similar to the 150 mg capsules, with instructions to take 2 capsules (400 mg) daily. At a follow-up visit after the reduced dose was ordered, an EKG again showed QT prolongation. During this visit, it came to light that Tasigna capsules are packaged in a 2-part blister pack of 28 capsules, each with pre-printed instructions to take 2 pills every morning and 2 pills every evening. This caused confusion about what dose to take.

Even though the prescription label attached to the outside of the Tasigna blister packs instructed the patient to take two 200 mg capsules daily, the patient took 2 capsules twice daily as listed on the blister packs. So, instead of decreasing the dose from a total of 600 mg daily to 400 mg daily, as per the manufacturer's labeling, the patient accidentally increased the dose to 800 mg daily (400 mg twice daily). Fortunately, the error was identified during the office visit and it was quickly corrected.  

Key Takeaway: It is crucial for sponsors to evaluate product packing design issues such as this one early in the development process to minimize the chance of similar errors occurring.

ISMP Medication Safety Alert®, Acute Care: Volume 19, Issue 10


 
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.

 

200 Lakeside Dr, Suite 200
Horsham, PA 19044
215-947-8306
www.med-errs.com

info@med-errs.com