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Volume 4, Issue 2
UPDATE-ERR™ Spring 2011
News from ISMP
Brand name extension could be dangerous to kids. A community pharmacist alerted us to a concern regarding acetaminophen marketed under the Triaminic brand name, TRIAMINIC FEVER REDUCER. This product contains only acetaminophen. Since the brand name Triaminic has been used for many years as a decongestant-antihistamine combination product, most consumers probably associate "Triaminic" with a cough and cold medicine. The pharmacist had noticed a woman trying to purchase a bottle of store brand acetaminophen liquid along with a bottle of Triaminic Fever Reducer. After speaking with the woman, the pharmacist learned she had no idea that both products contained acetaminophen; she just knew that she wanted something for her child's fever and "Triaminic" for his cold symptoms. The cues on the Triaminic label were not enough to signal that this Triaminic product was different than the one she'd come to know. Had the pharmacist not intervened, the woman would have given both products to her children, risking toxicity. We've spoken in the past about the difficulties FDA has with regulating over-the-counter (OTC) brand name extensions, even when the actual product ingredient is completely different from ingredients in the original product that uses the brand name. For OTC "monograph" drugs, a new drug application or abbreviated new drug application does not have to be filed. Monograph drugs are designated OTC drugs that have not been approved by FDA by direct application but are legally marketed under regulations referred to as "OTC monographs" established through the FDA's OTC Drug Review. According to FDA, monograph drugs are "generally recognized as safe and effective" for their intended uses. Thus, companies are able to market certain OTC products, like Triaminic Fever Reducer, without prior FDA approval of the product name. FDA has occasionally acted when name confusion has led to errors, as it did last year when MAALOX TOTAL RELIEF, which contained only bismuth subsalicylate. The company was asked to change the name but instead took the product off the market. Perhaps it would be safest for pharmacies to avoid stocking Triaminic Fever Reducer.
ISMP Medication Safety Alert! March 24, 2011

President's Message

Dear Med-ERRS Friends and Colleagues,

In addition to our usual project workload, we are feverishly preparing for our exhibit at the INTA Annual Meeting in San Francisco. If you will be there, please visit us at Booth #711. While we won't be serving any convenience store fare, we will have plenty of information about safety and regulatory issues that may affect your current and proposed trademarks.

If you would like to make a specific appointment with us, we are happy to schedule that, please inquire.

If you will not be in San Francisco, but have medication error prevention questions about trademarks, package labels or other product attributes, please call or email us for a personalized consultation.

We look forward to seeing you in San Francisco!

Warm regards,

Susan


In the News

FDA issues Guidance for OTC product dosage delivery devices


Transition to single concentration for pediatric acetaminophen products

New REMS strategies announced for opioid drugs



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Med-ERRS 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.
  • 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. 


Med-ERRS, Inc.

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