Close

Volume 8, Issue 1 UPDATE-ERR Winter 2015

President's Message

Dear Friends and Colleagues:

A brand new year for more new regulatory changes!

If you were not already aware, EMA's revised guideline went into effect the first of the New Year and this guideline introduces a substantial change with regard to brand name submission rules. From this point forward, up to two proposed (or invented) names per marketing authorization application can be accepted by the Name Review Group (NRG). Only a maximum of two names per name review request can be proposed for consideration at each NRG meeting.

Before January 1, sponsors were able to propose up to four names for consideration. This change by the EMA has no retroactive effect and all names accepted by the NRG prior to January 1, 2015 will be retained.

This is the first change of many this year to officially go into effect. Health Canada's trademark guidance effective date is slated for June 13, 2015 and we are still anticipating the FDA to release their finalized trademark guidance sometime in the near future. 

Stay tuned for another exciting year in trademarks!

Warm regards, 

Susan


 
In the News

 Upcoming Conferences:

PTMG 2015 Spring Meeting in Venice

Med-ERRS will attend this year's Spring PTMG conference in Venice, Italy. For those who plan to attend the conference and are interested in meeting with us, please email Diane Bernstein at dbernstein@med-errs.com.


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

Look-alike brand name pairs: Covaryx HS and Covera HS

A prescriber intended to prescribe COVARYX HS (esterified estrogens and methyltestoterone) to help treat a patient's vasomotor symptoms associated with menopause. However, he inadvertently selected the calcium-channel blocker COVERA HS (verapamil extended release) from his electronic prescribing application. The Covera HS prescription was electronically sent to the pharmacy and dispensed. The patient took  Covera HS for 10 days before contacting her physician. It appears that Covaryx HS is an unapproved product. The US Food and Drug Administration should review the marketing status and investigate the safety and efficacy of the product. A name change should also be requested.

               

 

ISMP Medication Safety Alert®, Community/Ambulatory Care: Volume 13, Issue 10


ISMP's Thoughts on FDA's Proprietary Name Draft Guidance:

    OTC Drugs and Brand Name Extension Concerns

The Institute for Safe Medication Practices (ISMP) has submitted comments regarding the US Food and Drug Administration (FDA) Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs. ISMP is in support of FDA’s guidance to manufacturers for protecting patient safety during development of proprietary names for drug products.

ISMP's letter (www.ismp.org/sc?id=424) specifically calls attention to the issue of over-the-counter (OTC) drugs and umbrella names (brand name extensions), where a well-known, successful, OTC brand name is recycled for a new product that contains an active ingredient or ingredients that differ from those in the original product. For example, CLARITIN EYE (Bayer) does not contain loratadine, and ZYRTEC ITCHY EYE DROPS (McNeil) does not contain cetirizine. Instead, they each contain another antihistamine, ketotifen fumarate. Umbrella names have been associated with patient and practitioner confusion regarding the product’s actual ingredients, strength, and concentration. This has led to errors in which the wrong product or dose was taken or the product was used when contraindicated. 

Product names that are misleading can also cause confusion when treating side effects or accidental ingestion of these products. Although full ingredients are listed in a product’s Drug Facts panel, this information is sometimes overlooked by the consumer due to confirmation bias. 

ISMP's Suggestions: Brand-name extensions should not be allowed unless at least one ingredient from the original product is present in the new or modified product. 

ISMP Medication Safety Alert®, Community/Ambulatory Care: Volume 13, Issue 10


 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
www.med-errs.com

info@med-errs.com