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Spring 2012 Med-ERRS Newsletter

Volume 6, Issue 2 UPDATE-ERR™ Spring 2013

President's Message

Dear Friends and Colleagues:

Happy Spring!

We are excited about the warmer weather and about introducing our newly branded service offering, EVALUATE-ERRsm. Exclusive to Med-ERRS, EVALUATE-ERR is 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. Med-ERRS employs Failure Mode and Effects Analysis (FMEA) to determine which path or choice to follow to minimize the risk of error and provide specific recommendations and error-reduction strategies. 

As you may recall, in late 2012, the FDA released a draft guidance focusing on the utility of performing proactive risk-assessments in the early stages of pharmaceutical product design. Over the past several years, Med-ERRS has become more involved with providing this type of service and has developed extensive experience in performing these assessments for our clients using EVALUATE-ERR. 
                        
Health Canada also recently released a new draft guidance titled, “Review of Drug Names for Look-alike Sound-alike (LASA) Attributes.” This guidance outlines what will soon become a requirement for all sponsors to perform a full-scale look-alike, sound-alike brand name assessment to demonstrate the safety of a proposed name. Sponsors will soon be responsible for carrying out testing procedures such as database searches, simulations and Failure Mode and Effects Analysis to demonstrate that their submitted brand name is not likely to cause confusion with other health products that are authorized for use in Canada.

Med-ERRS is currently working on adapting our services to meet these requirements and we are happy to discuss any questions you may have in regards to this new information. 

Susan


In the News

FDA announces draft guidance, "Safety Considerations for Product Design To Minimize Medication Errors." Federal Register announcement Draft Guidance

Health Canada announces new draft guidance for industry, “Review of Drug Names for Look-alike Sound-alike (LASA) Attributes.” Draft Guidance

Upcoming Meetings Med-ERRS will be Attending

Med-ERRS will be attending the International Trademark Association’s annual meeting from May 4-8, 2013 in Dallas, Texas.

Stop by and say hello at booth 316.


Newest Additions to the Med-ERRS Team

Susan O’Donnell: Susan has taken on the responsibilities of Project Coordinator for the team. She will be responsible for creating the project surveys for proposed trademarks being tested and tabulating the results for analysis by the Med-ERRS professional team. Susan comes to us with many years of experience as a pharmacy technician having worked in mail order pharmacy. Susan is a graduate of Temple University and resides in Hatboro, PA with her husband and son.

Diane Bernstein: Diane has taken on the responsibilities of Marketing Development Representative. She will be responsible for all sales and marketing related activities within the company. In addition, she will oversee the advertising and promotion initiatives. She will also be the initial point of contact for client and media related inquiries. Diane comes to us with a number of years of experience working as a pharmaceutical sales representative in a specialty business unit. Diane received her degree at Pennsylvania State University and currently resides in Yardley, PA with her new husband.


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

KADCYLA vs. HERCEPTIN Mix-Ups

Genentech’s KADCYLA (adotrastuzumab emtansine) is an antibody drug conjugate (ADC) that contains the HER2 antibody trastuzumab linked to emtansine, a potent cytotoxic agent. KADCYLA is for patients with HER2-positive metastatic breast cancer who previously received trastuzumab (HERCEPTIN), another monoclonal HER2-targeted antibody, and a taxane, separately or in combination. Kadcyla was recently approved by the US Food and Drug Administration (FDA). Unfortunately, the official name of this product, ado-trastuzumab emtansine, may not be fully communicated when prescribed or may be read incompletely, thus creating a significant risk of confusion with trastuzumab. The dosing and treatment schedules for these drugs are quite different, so if one is accidentally used for the other, the patient might experience severe toxicity or inadequate therapy.

For example, the recommended dose of ado-trastuzumab emtansine (Kadcyla) is 3.6 mg/kg given as an IV infusion every 3 weeks (21-day cycle) as a single agent until disease progression or unacceptable toxicity. Doses higher than that should not be given. Trastuzumab is prescribed in doses up to 8 mg/kg every 3 weeks—more than twice the maximum dose of Kadcyla.
 
ISMP recommends that drug information systems and guidelines employ strategies to differentiate the names and warn against confusion as a proactive risk reduction strategy. Ideally, prescribers and medication safety leaders should promote use of both the brand and generic name when communicating orders on preprinted order sets or computer prescriber order entry systems. Such a redundancy can be helpful in reducing error potential.

Due to the serious nature of this potential error, just this week, ISMP issued a NAN Alert (National Alert Network), which can be viewed by clicking here.
Excerpted from ISMP's Medication Safety Alert! Newsletter: Volume 18, Issue 5


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.
  • new! 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 world wide 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