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Volume 2, Issue 3 UPDATE-ERR™ Spring 2009

President's Messaage

Summer 2009

Have you or any of your colleagues had the pleasure of receiving an FDA communication asking you to conduct an FMEA or usability testing on your product? It seems that the requests by FDA to provide them with documentation of having performed these activities are growing by leaps and bounds, and Med-ERRS is here to help. Failure Mode and Effects Analysis (FMEA) is the underlying methodology that we have always used to evaluate the trademarks, package labels and healthcare technology devices. Now, with this growing number of requests by FDA, we can use that same methodology to evaluate a unique aspect of your product, whether it be a new form of drug delivery, nomenclature for a line extension, or a particular adverse effect that could lead to increased patient harm.

Med-ERRS also partners with human factors experts to provide usability testing on your package labels and devices. Used in conjunction with FMEA, usability testing can add another dimension of safety to your product as well as help to meet these additional requests from regulatory authorities.

Contact us if you are interested in learning more.

Warm regards,

Susan

Articles of Interest

To Err is Human - To Delay is Deadly
http://www.safepatientproject.org/safepatientproject.org/pdf/safepatientproject.org-ToDelayIsDeadly.pdf

Survey on LASA drug name pairs:
Who knows what’s on your list and the best ways to prevent mix-ups?
  http://www.ismp.org/newsletters/acutecare/articles/20090521.asp

Potential Signals of Serious Risks:
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008

Docket No. FDA-2008-N-0648, OC 2009136.  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; PDUFA Pilot Project Proprietary Name Review.
http://edocket.access.gpo.gov/2009/pdf/E9-14212.pd

Ask an Expert

If you have a question related to one of Med-ERRS services or have an industry-specific inquiry, please Click Here and one of our experts will get back to you with an answer.

 

ISMP Information

Institute for Safe Medication Practices (ISMP) is pleased and excited to announce the launch of CoConsumer Med Safety Websitensumer Med Safety (www.consumermedsafety.org), the first and only website on the internet exclusively designed to bring the message of medication safety to the consumer market.

ISMP steadfastly believes that consumers can and want to play a key role in their safety when receiving and taking medications. This unique, interactive website offers consumers a reliable source of information, rich with stories and advice that will clearly impact consumer medication safety. 

Benadryl Gel for the skin has been mistaken as an oral medicine:
March/April 2009
http://www.ismp.org/Newsletters/consumer/Issues/20090301.asp

It may not be safe to cut a medicine patch:
May/June 2009
http://www.ismp.org/Newsletters/consumer/Issues/20090501.asp

Pharmaceutical Bar Coding: Moving Forward in Canada: 
May/June 2009
http://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2009-4-PharmaceuticalBarCodingMovingForwardinCanada.pdfSubscribe to ISMP Newsletters

 

Med-ERRS Services

****** Please contact us for our 2009 pricing******

  • Trademark Evaluation: Med-ERRS has developed a service for evaluating the safety of trademarks called the ERRS MODELTM, 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. 
  • EVALUATE-ERR: Conducts an in-depth analysis of error reports using data from the client as well as other medication error databases.

Company Spotlight

D.Portilho Trademark Consulting & Auditing

Deborah Portilho, a Brazilian trademark attorney and marketing specialist, has recently launched the first company specializing in trademark audits in Brazil - D.Portilho Trademark Consulting & Auditing. According to Deborah, who has vast experience in the area of Intellectual Property, particularly as relates to Pharmaceutical Trademarks , trademark audits facilitate both the management and the strategic decision-making processes, provide agility to the marketing department and, more importantly, contribute to the effective reduction of the costs related to the administration of the company's trademark portfolio. You can learn more about this specialty company by visiting their website at www.dporthilo.com.br. Deborah can also be reached directly at mail@dporthilo.com.br and by telephone at 55 21 2542-1591.

Tepper & Eyster, PLLC

We are pleased to announce the formation of Tepper & Eyster, PLLC, a new law firm with old roots in the pharma trademark area. Founding members Maury Tepper and Kathryn Eyster have both been actively engaged in helping companies develop, protect and maintain pharmaceutical trademarks. Maury has previous industry experience with GlaxoSmithKline and has been a speaker and participant at all of the FDA Public meetings dealing with proprietary name review. Tepper & Eyster will maintain a focus on pharmaceutical marks. You can reach them at (919) 861-8901 or email mtepper@teiplaw.com.

This section details new and/or existing organizations that provide valuable services throughout the pharmaceutical / biotech industry. Med-ERRS provides these links solely for convenience and not as an endorsement of the content of these third party sites or any products or services offered on said sites.


Med-ERRS

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Horsham, PA 19044
215-947-8306