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Fall 2013 Med-ERRS Newsletter

Volume 6, Issue 4 UPDATE-ERR Fall 2013

President's Message

Dear Friends and Colleagues:

We can’t believe that summer is already over and the holidays are only a short few months away. 

Med-ERRS recently had the opportunity to attend the Pharmaceutical Trade Marks Group (PTMG) Annual Meeting in Vienna, Austria. This year, the meeting focused on “Barriers to a Global Brand.” This was a highly relevant topic for Med-ERRS and our clients considering the ever-increasing challenges the pharmaceutical and biotech industries currently face in the business of developing and protecting its trademarks. 

I had the honor of speaking during the meeting on the impact of new proposals on name creation and the issues our industry currently faces in evaluating and selecting appropriate trademarks on a global scale. If you are currently facing any of these challenges, please don’t hesitate to reach out to us as we would be happy to help you through this increasingly complex process of finding a safe and viable trademark for your pharmaceutical product. 

Lastly, many of you are probably wondering when the new FDA guidance on trademark nomenclature will be released  our current projection is that it may be released this Spring. We will be sure to include an announcement and a link to the new guidance when it becomes available. 

We hope that you enjoy the rest of the year and although it may be early – we wish you the happiest of holidays.

Warm regards,
Susan


In the News

Current Events Affecting Global Trademark Submission

New Photo Album on the Med-ERRS Website

Our photos are up from the 2013 Annual INTA Meeting and PTMG's 87th Conference. Many of our friends, clients and colleagues stopped by to see us this year while we were in both Dallas and Vienna. We captured many of these moments and added them to an album on our website. You may view these photos by clicking here

Please be sure to take a look as you may be featured in the album.


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

GlycoTrol vs. Glucotrol Trademark Mix-Ups 

A patient was discharged from a hospital to a long-term care (LTC) facility with the dietary supplement “Glycotrol” listed among the medications she had taken home. But at the LTC facility, the product was communicated as GLUCOTROL (glipiZIDE), an antidiabetic agent. No doubt many would see (or hear) GlycoTrol as Glucotrol given their nearly identical names, and assume that the drug name was misspelled. That’s evidently what happened here, and the patient’s LTC physician prescribed Glucotrol, believing the patient had taken the drug prior to hospitalization. The patient became hypoglycemic, which required readmission to the hospital. While several strategies by the LTC staff may have helped prevent this error, we call upon the maker of GlycoTrol to change the name of its product to prevent mix-ups.
ISMP Medication Safety Alert®, Acute Care: Volume 18, Issue 16

                  

It’s Letairis, not Letaris

LETARIS is a formerly marketed Dutch brand name for letrozole, which is indicated for the treatment of local or metastatic breast cancer that is hormone receptor positive or has an unknown receptor status in post-menopausal women. Letrozole is known by the brand name FEMARA in the US. LETAIRIS (note the additional letter i after the letter a) is ambrisentan, a drug approved by the US Food and Drug Administration (FDA) for primary pulmonary hypertension. Unfortunately, these names are so close that patients are in danger of getting the wrong drug should a misspelling occur. Recently, a patient admitted for exacerbation of pulmonary hypertension had a pre admission medication form on which Letairis was misspelled as“Letaris.” A search of Micromedex 2.0 for Letaris provided a hit for “letrozole,” a 2.5 mg tablet. Since Letairis is available as a 5 mg tablet, two letrozole 2.5 mg tablets might have been used. Fortunately, given the patient’s diagnosis, a pharmacist contacted the patient’s physician and the error was recognized. The patient’s own Letairis was used until a supply could be obtained. Spelling it as Letairis does properly refer one to ambrisentan in Micromedex. However, Lexicomp, Facts and Comparisons, and Monthly Prescriber’s Reference (MPR) do not list Letaris. We have notified Micromedex about this issue. Incidentally, checking with some hospital formularies that can be accessed online, we found that a few misspelled Letairis as Letaris.
ISMP Medication Safety Alert®, Acute Care: Volume 18, Issue 20

Name Mix-Ups Due to Computer System Shortcuts & Confirmation Bias

A LTC facility received bacitracin ointment from the pharmacy for a resident. The resident did not have an order for bacitracin ointment, but she did have an order for a different antibiotic ointment, BACTROBAN (mupirocin). Upon investigation, it was determined that a technician at the pharmacy incorrectly entered the order as bacitracin ointment, and the error was not detected by the pharmacist who checked the order. When entering the order into the pharmacy computer, the technician used a common shortcut and typed just the first three letters of the drug name – BAC – into the computer. Errors can easily occur if there are multiple drug names with the same first three letters, as people tend to see what they believe they should see, not necessarily what is on the screen. This is an example of confirmation bias: seeing what you expect to see and missing information that signals you have selected the wrong product. Confirmation bias is particularly prevalent in experienced staff because they can picture in their mind what they are expecting to see.
ISMP Medication Safety Alert®, Long-Term Care Advise-ERR: Volume 1, Issue 2

Our 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.
  • EVALUATE-ERRsm: 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.
  • 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 worldwide regulatory authorities.
  • Safety Consulting: Provides consultative services which are related to a variety of medication safety-related issues.
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