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Volume 8, Issue 3 UPDATE-ERR Summer 2015

President's Message

Dear Friends and Colleagues:

Over the last few months, Med-ERRS has been involved in various types of safety-related projects in addition to our usual trademark safety testing evaluations to help proactively prevent medication errors from occurring. We have been keeping busy conducting a broad range of safety services covering many areas of medication safety and various stages of a product’s lifecycle including:

  • conducting proactive product risk assessments
  • performing packaging and labeling design and evaluations
  • arranging and overseeing Advisory Boards
  • conducting professional medication safety educational sessions

Over the years, we have found that our clients often need and value these types of proactive services to assist them in reducing the potential for future medication errors involving their products. In fact, the FDA has been encouraging proactive safety evaluations and risk assessments, such as the ones we have been conducting recently. We foresee these types of services keeping us very busy in the years to come.

To read more about some of these unique safety services that we offer, please click here and select either Safety Consulting or Package and Label on the left side of the screen.

Warm regards, 

Susan
Susan Proulx


In the News

 Upcoming Conferences 

 PTMG 2015 Fall Meeting in Warsaw

Med-ERRS will attend this year's annual Pharmaceutical Trademarks Group Autumn meeting in Warsaw, Poland from September 30 through October 2. Both Susan Proulx (President) and Nancy Globus (Director of Operations) plan to attend. If you would like to  schedule a time to speak with Susan or Nancy while in Warsaw, please email dbernstein@med-errs.com.


ISMP NAN Alert Warns of Potentially dangerous confusion between: 

Bloxiverz (neostigmine) injection and Vazculep (phenylephrine) injection

March 23, 2015 - ISMP is alerting hospitals, ambulatory surgical centers, and anesthesia professionals about the potential for dangerous mix-ups between two relatively new presentations of older medications, neostigmine injection and phenylephrine injection.

Elat Pharmaceuticals is currently manufacturing BLOXIVERZ (neostigmine) and VAZCULEP (phenylephrine). In the past 3 months, ISMP has received 8 practitioner reports expressing concern about look-alike packaging of Bloxiverz 10 mg/10 mL (1 mg/mL) and Vazculep 50 mg/5 mL (10 mg/mL). The vials and outer cartons look similar in size, color, and design. Several hospitals have reported that vials or cartons of the 10 mg Bloxiverz product were found mixed in with Vazculep 50 mg/5 mL (10 mg/mL) vials or cartons. Of the 8 reports, five were close calls in which the wrong product was actually used during sterile compounding. Fortunately, in each reported case, the error was identified during an independent check by a second person. If the wrong drug reached the patient, it could result in a serious adverse drug event.

Key Takeaway: It is vital for sponsors to develop safe and appropriately differentiated packaging and labeling for each of their products to minimize the potential for product confusion and future medication errors, especially when both products involve the same route of administration and have similar dosage strengths.

This article has been excerpted for this newsletter. To view the full article, including suggested steps to safeguard against mix-ups, please read the full NAN Alert from the ISMP website at http://www.ismp.org/NAN/files/NAN-20150320.pdf.


Med-ERRS is on LinkedIn® 

We invite you to connect with Med-ERRS to stay up-to-date on current industry-related news. To follow Med-ERRS on LinkedIn, please click the button below and select the 'follow us' button at the top right corner of your screen. 


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.
 

200 Lakeside Dr, Suite 200
Horsham, PA 19044
215-947-8306

info@med-errs.com
www.med-errs.com