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Volume 8, Issue 2 UPDATE-ERR Spring 2015

President's Message

Dear Friends and Colleagues:

Med-ERRS is excited to update you on yet another new trademark guidance that was released. In  October 2014, Brazil's Health Surveillance Agency (ANVISA) issued Resolution RDC No. 59/2014 which introduced new rules both regarding the composition of pharmaceutical trademarks themselves and the possible conflicts of new brand names with existing ones. 

This new resolution which came into force upon publication, repeals the 2003 ANVISA Resolution on medicine labeling and naming and brings some notable changes including:

  • elimination of the previous requirement of three separate letters to dissociate similar word signs
  • new rules for drug name acceptance (the drug name "must be graphically and phonetically different enough with regard to other registered drug names")
  • extension of ANVISA's discretionary power on the assessment of trademarks
  • some definitions and restrictions of important regulatory elements (e.g. modifiers and umbrella trademarks) 

Please keep in mind that these new rules are applicable to all products subject to registration, with the exception of generic and immunotherapy pharmaceuticals. To view the new resolution, please click here. Please see our In the News section of this newsletter for an article written in English summarizing the new resolution and its potential impact on the industry.

Warm regards, 

Susan
Susan Proulx


In the News

 Upcoming Conferences 

 

International Trademark Association Annual Meeting in San Diego

Med-ERRS will attend this year's annual INTA conference in San Diego, CA from May 2-6. We will be located at booth #2234 in the exhibit hall and would love to say hello to our valued clients and colleagues who are planning to attend. If you would like arrange a time to speak with Med-ERRS, please email Diane Bernstein at dbernstein@med-errs.com.


  Human Factors and Ergonomics Society's 2015 International Symposium in Baltimore

Med-ERRS will attend the HFES symposium in Baltimore from April 26-29. If you would like to  schedule a time to speak with Susan Proulx (President of Med-ERRS) while in Baltimore, please email dbernstein@med-errs.com.


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

Name confusion with FARXIGA and FETZIMA

The US FDA is aware of several reported mix-ups due to name confusion between FARXIGA (dapagliflozin) and FETZIMA (levomilnacipran). Farxiga was approved in January 2014 to lower blood glucose levels in adults with type 2 diabetes when used along with diet and exercise. It is available in 5 and 10 mg tablets. Fetzima was approved in July 2013. It is a selective norepinephrine and serotonin reuptake inhibitor for major depressive disorder. The drug is available in 20, 40, 80 and 120 mg extended-release capsules. 

Upon review of the 5 medication error reports received by FDA, it is believed that the errors can largely be attributed to the drugs being approved and marketed within 6 months of one another. Both drug names begin with the letter F and end with the letter A, and are of the same length and number of syllables. Prescribers and pharmacists may choose the wrong item from computer screens. Furthermore, the container labels might appear similar since both display the proprietary name of the product in red font (see figures below).

Med-ERRS Key Takeaway: The length and number of syllables in a name along with the beginning and ending letters can cause confusion, especially when both products enter the marketplace at about the same time.

                  

 
 
ISMP Medication Safety Alert®, Community/Ambulatory Care: Volume 14, Issue 1


FDA Drug Safety Communication:

FDA Requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients

In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. Food and Drug Administration (FDA) is requiring additional label warnings prohibiting sharing of these injectable medicines. Insulin pens and pens for other injectable diabetes medicines should never be shared among patients, even if the needle is changed. Sharing pens can result in the spread of serious infections from one patient to another. To promote safe use, we are requiring that pens and packaging containing multiple doses of insulin and other injectable diabetes medicines display a warning label stating “For single patient use only.”

Insulin and other injectable diabetes medicines are used to help lower or regulate blood sugar, which, when uncontrolled, can increase the risk for serious complications, including blindness, nerve and kidney damage, and heart disease. Injectable diabetes medicines can come in pen-shaped devices with either a reservoir or cartridge containing multiple doses of medicine (see list of medicines in Table 1 below). Each pen is designed to be safe for just one patient to use multiple times with a new, fresh needle for each injection. Pens must never be used for more than one patient because blood may be present in the pen after use. Sharing pens can lead to transmission of infections such as the human immunodeficiency virus (HIV) and hepatitis viruses.

Since 2008, we have learned of thousands of patients possibly exposed to infections that are transmitted through blood from the sharing of multi-dose pen devices for insulin and other injectable diabetes medicines (see Data Summary).1-4 No confirmed cases of actual infection transmission have been reported, but sources of infection are often difficult to identify and may go unreported. In response to the reports of potential exposure, FDA and other organizations have issued multiple safety alerts, including a 2009 FDA Health Care Professional Sheet, and launched campaigns warning against the sharing of insulin pens.

The “For single patient use only” warning will appear on the labels affixed to the pens and on the pen cartons. Additional warnings against sharing pens will also be added to the prescribing information and to the patient Medication Guides, Patient Package Inserts, and Instructions for Use.

We urge health care professionals and patients to report medication errors or side effects involving diabetes medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Article is excerpted from FDA.gov at http://www.fda.gov/Drugs/DrugSafety/ucm435271.htm (2-25-2015)


 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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