Summer 2013 Med-ERRS Newsletter

Volume 6, Issue 3 UPDATE-ERR Summer 2013

President's Message

Dear Friends and Colleagues:

Happy Summer!

The regulatory agencies have been busy since our last newsletter. Two new guidances were recently released, one by the FDA and the other by the EMA.

In April, the FDA released its second guidance, in its planned series of three relating to medication safety. The draft guidance entitled, "Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” provides a set of principles and recommendations to ensure that crucial elements of a product’s package and labeling are designed to promote safe dispensing, administration and use of the product. While much of the information in the guidance coincides with our recommendations to clients, we believe some minor changes should be made before it is finalized. We provided the FDA with our thoughts and suggestions during the comment period that took place a few months ago.

In early June, the EMA released version 6 of its nomenclature guidance, titled, "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure." The 6th update further clarifies aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and product-specific concerns in proposed names. Also, the procedure for submission of proposed name requests is streamlined and further clarified. The most notable change in the new draft guidance is the number of names sponsors may submit per marketing-authorization application. Version 6 states that sponsors may submit only two names for consideration, whereas version 5 allowed for 4 names.

We expect the 3rd FDA guidance to be released later this year. This guidance will focus on best practices for the development and testing of proposed proprietary names to minimize risks associated with drug product nomenclature. We're also awaiting the final version of the Health Canada nomenclature guidance. We expect this to be released by the end of the year. Please see below for links to the three recently released draft guidances.

We hope you enjoy the rest of your summer. Please do not hesitate to reach out to us if you need assistance with any medication safety related activity.

Warm regards,

In the News



Upcoming Meetings Med-ERRS will be Attending

Med-ERRS will be attending PTMG's annual meeting from October 2-5, 2013 in Vienna, Austria. Susan Proulx will be speaking at this event regarding trademark safety issues and recently released guidances.

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

Ophthalmic Container Labels Changing 

FDA has apparently influenced eye drops manufacturers to stop using color coding on ophthalmic container labels. But the use of color-coded caps to indicate drug class is continuing. For example, Bausch and Lomb uses black and white print on eye drops container labels. Until people get used to the new style and realize the importance of reading labels within each color-coded class, medication errors will likely occur. An error was discovered recently when a pharmacy employee went to pull a cyclopentolate 1% eye drops container from a medication carousel and picked up tropicamide 1% instead. Both medications are cycloplegics (redcaps) and were mixed in the same storage bin. The new label also has very small print. This error highlights the importance of product verification using barcode scanning as well as reading each individual container label when selecting it and when returning it to the storage bin.
ISMP Medication Safety Alert®, Acute Care: Volume 18, Issue 14


A 15-year-old boy with Autism was prescribed TENEX (guanFACINE), a drug indicated to treat attention deficit and hyperactivity disorder (ADHD). The prescriber called in the prescription for Tenex along with 3 other medications. According to the prescriber, the pharmacy made a mistake when interpreting her telephone order and dispensed the anxiolytic agent XANAX (ALPRAZolam). Adding to the potential for confusion of these two sound-alike drug names is the fact that both Tenex and Xanax are available in 1 and 2 mg dosage strengths. The boy’s mother caught the error when she reviewed her son’s medication after arriving home from the pharmacy. When taking verbal orders, pharmacy staff should perform a read back (and spell back for drugs that are known to cause confusion) of the medication name, strength, dose, and frequency of administration for verification. When leaving voice mail prescriptions, the prescriber should spell out the drug name (e.g., T-E-N-E-X) and use single digit affirmation of the dose (e.g., one – five instead of fifteen) with confused drug names and doses. Another strategy to prevent this error is to use both brand and generic names when prescribing these drugs. Additionally, pharmacists should always review the patient’s profile.
ISMP Medication Safety Alert®, Community/Ambulatory Care: Volume 12, Issue 4

Over-the-Counter Brand Name Extensions: Family Tradenames

Over-the-counter (OTC) medication manufacturers can cause confusion and possible patient harm when they extend the use of popular brand names within a line of products. Many of these brand name extension products are packaged in the same type, size and color containers as the “original” product, but do not contain the same active ingredient. Without FDA review and specific approval of the OTC product names, companies have capitalized on well-known and trusted brand names and used them for other products, even if the product has different ingredients and uses.

Med-ERRS can provide consulting services for this type of issue using EVALUATE-ERRsm. This service offering can help develop appropriate tradenames across family brand names.

Examples of Brand Name Extensions

Same name, opposite effect

For many years, and despite several formulation changes, the well-known KAOPECTATE brand name has been used as an anti-diarrheal product. So imagine our surprise (and dismay) when we learned about a new Kaopectate product – a stool softener! Incredibly, the brand name Kaopectate is now replacing another well-known brand name, SURFAK, for a docusate calcium product. Thus, the same brand name is used for products with opposing indications.

Same name, different active ingredient


ALLEGRA ALLERGY contains the original active ingredient, fexofenadine, however the newly released ALLEGRA ANTI-ITCH COOLING RELIEF contains different active ingredients, diphenhydrAMINE and allantoin. In this case, the manufacturer carried over design elements from the existing Allegra trade dress (e.g., purple-colored cartons, stylized Allegra name) which reinforce the association of these products with the original Allegra products and increase the risk of confusion. The extension of the Allegra brand name increases the risk for a consumer to mistakenly believe that products that share a common proprietary name contain the same active ingredients. If patients do not identify that the product contains diphenhydrAMINE, they may use another topical or oral diphenhydrAMINE product in addition to the Allegra product. The overuse of diphenhydrAMINE can have serious adverse effects. The extension of the brand name Allegra may also introduce confusion when treating adverse effects of these products. Moreover, patients with allergies or contraindications to diphenhydrAMINE may not readily identify these products as ones they should avoid. 

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.
  • 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