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Volume 9, Issue 1 UPDATE-ERR Summer 2016

 

President's Message

Dear Friends and Colleagues:

About a year ago, the Health Canada a guidance requiring companies to “safety test” their proposed drug brand names before submission to the regulatory authority went into effect. This requirement incorporates a long, arduous process that can be complex and time consuming.

Over the past year, Med-ERRS has worked on a number of trademark projects for name submission to Health Canada. Some of these projects were global in nature, and Canada was just one piece of the regulatory and safety puzzle; others were single-country projects that focused just on Canada. Each had their challenges.

We learned some things over the year and refined our process accordingly. One lesson is that if you are trying to achieve a global name, you must include Canada testing early in the process, as the rigors of the guidance may “knock out” a potential name that may be acceptable in other jurisdictions. We have heard some good news as well. Some  names that Med-ERRS tested have been granted a notice of compliance (NOC). This tells us that our methodology for complying with the guidance is acceptable to Health Canada. Please contact us if you would like to hear more about this methodology.

There are no official statistics yet of how many names Health Canada has reviewed under the new guidance and how many have been accepted, but if we hear anything, we will report it here.

Warm regards,

Susan

Susan Proulx


In The News


Upcoming Conferences

 PTMG 2016 Fall Meeting in Oslo

Med-ERRS will attend this year's annual Pharmaceutical Trademarks Group Autumn meeting in Oslo, Norway from October 5 through October 8. Susan Proulx (President of Med-ERRS) plans to attend. If you would like to  schedule a time to speak with Susan while in Oslo, please email darbitman@med-errs.com.


Recent News from ISMP Medication Safety Alert! Newsletter

Misread handwritten order.

ISMP recently received a report from a long-term care (LTC) facility about an order for clonazepam 1mg PO TID that was misinterpreted as LORazepam 1 mg PO TID (Figure1) by the pharmacy. Fortunately, a nurse caught the error before the resident received the wrong drug. While nurses may be familiar with residents and know which benzodiazepine the physician has prescribed, the pharmacist filling the prescription may not. Transitioning to a fully utilized electronic health record (EHR) with electronic prescribing can help eliminate the risk of misinterpreting handwritten orders.

ISMP June 2016 Image

Figure 1. Handwritten order for clonazepam misread as LORazepam

Excerpted from ISMP Medication Safety Alert! Community/Ambulatory Care edition Volume 15, Issue 6, June 2016

 


Label characteristic contributes to errors.

The way the manufacturer’s strength is oriented on a product container label is an important safety consideration, especially for pharmacists, pharmacy purchasers, and medication safety officers.  The Apotex brand of ARIPiprazole tablets is a case in point. Take a look at the bottles in Figure 1. Bottle size, shape, label, and container colors are all similar. Still, you would certainly be able to identify what the medication is. It is the way the product strength appears that is troubling.

Since most drug containers are round, when strengths appear to the far right of the label, they may easily be missed if the container is turned just slightly (Figure 1). The drug name may be readily visible but not the strength. Confirmation bias could lead to a mix-up. In this case, the font size used to express the strength is also much smaller than the font size used for the drug name, which may add to the confusion. A pharmacist told ISMP that he recently picked up the wrong bottle and nearly dispensed the wrong strength. Sometimes graphic designers and reviewers view sample label print-outs on a flat surface, without considering how the label will look when applied to a round container, or how the product will be stored and later used.

When we checked label graphics from other US ARIPiprazole generic manufacturers, they all had the strength either immediately following the drug name on the same line or had the strength centered immediately beneath the drug name, as it should be. When there’s a choice of brands for specific products, avoid labels that separate the dose/strength from the product name. A good reference to check for container label appearance is DailyMed, a service provided by the US National Library of Medicine (http://dailymed.nlm.nih.gov/dailymed/index.cfm).

ISMP January 2016 Image

Figure 1. Strength may easily be missed if the bottle is slightly turned to the right.

Excerpted from ISMP Medication Safety Alert! Community/Ambulatory Care edition Volume 15, Issue 1, January 2016


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Our Services

  • 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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