1. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 1 rxmark is the division of Interbrand Wood Healthcare providing proprietary research methodologies and consulting services for brand intelligence and nomenclature validation for the pharmaceutical, biotechnology and healthcare sectors www.rxmark.comwww.rxmark.com :: rxmark@interbrandwood.com :: 212.739.9670rxmark@interbrandwood.com ‘Evaluating Names for Similarities: Methods and Approaches’ Public Meeting Food and Drug Administration Institute for Safe Medication Practices Pharmaceutical Research and Manufacturers of America June 26th, 2003

2. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 2 Responses to the Panel Moderator

3. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 3 rxmark Responses to Panel Moderator  Question 2 (rxmark #1) Question  “Who do you include in your sample”? Response  “Each assessment contains two distinct sample components. The first sample component is a quantitative primary research study that represents the profile of healthcare professionals who we anticipate will either prescribe, dispense or administer the product. For the vast majority of projects, we include physicians specific to the profile of anticipated prescribers, nurses specific to the anticipated dispensing environment, and pharmacists and other dispensers such as unit clerks representing cross-section of dispensing environments, primarily hospital and retail, which is independent of the product profile. For example, a hospital–only product would also be validated by retail pharmacists to reflect a larger number of presently prescribed products as opposed to only those products administered in a hospital environment. The second sample component is a qualitative primary research study managed by an independent consultant, Neil M. Davis of Safe Medication Practices Consultants, and his study is conducted with individuals such as practicing pharmacists, nurses or pharmacy administrators who share his interest in minimizing medication error.”

4. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 4 rxmark Responses to Panel Moderator  Question 4 (rxmark #2) Question  “Are questionnaires self-administered”? Response  “My response will use the same distinction as I stated in my earlier response to the first question relative to sample. To recap, each assessment contains two distinct components. For the first sample component, the quantitative primary research study representing the profile of healthcare professionals who we anticipate will either prescribe, dispense or administer the product, we implement a variety of methodologies specific to the respondent type. For physicians specific to the profile of anticipated prescribers, the majority of studies use a combination telephone, voice mail and fax methodology, however we use face-to-face and online surveys as well. The same holds true for nurses. For pharmacists and other dispensers such as unit clerks representing cross-section of dispensing environments, we employ a secure, online, self-administered survey which provides the integration of verbal and visual stimulus such as a verbal or written order. For the second sample component, the qualitative primary research study with dispensing analysts, in the U.S. SMPC employs a secure, electronic, self-administered assessment delivered using e-mail.”

5. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 5 rxmark Responses to Panel Moderator  Question 6 (rxmark #3) Question  “Are your questions multiple choice or open-ended”? Response  “For the first sample component, the quantitative primary research study, we incorporate a number of different measures, and very often customize a survey for a particular respondent type. For the identification of what is communicated relative to the visual or verbal stimulus, it is an open-end response. The assessment by the respondent of the anticipated ability of the proposed name to be clearly communicated when spoken or written within the dispensing environment, we use a Likert scale, e.g., from one to ten with one representing unclear and ten representing clear. For the overall assessment of the proposed name in the context of its anticipated use, we combine a multiple choice of suitable, questionable or unsuitable, with an open-end response to articulate their assessment. For the second sample component, the qualitative primary research study with dispensing analysts, SMPC employs a similar approach regarding identification of what is communicated relative to the visual or verbal stimulus and the overall assessment.”

6. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 6 rxmark Responses to Panel Moderator  Question 8 (rxmark #4) Question  “Do you use an individual expert or an expert committee”? Response  “We have enjoyed an outstanding professional relationship, and myself personally, with Dr. Neil M. Davis of Safe Medication Practices Consultants for close to fifteen years. Neil has served as our independent ‘eyes and ears’ relative to the subject of medication error. For those of you you do not know Neil, he is a co-founder of the Institute for Safe Medication Practices, and it was in that role close to fifteen years ago that Michael Cohen and himself shared their view of how Interbrand Wood and rxmark, as companies with a significant role in the development of pharmaceutical trademarks, could address the issue of preventing medication error due to perceptually similar trademarks. We integrated their approach within a model designed to address the multitude of factors that impact pharmaceutical name suitability in 1991, and Neil continues to provide his assessment to this day. What I would add is that although Neil provides an overall assessment, his assessment is a reflection of the many individuals not only here in the U.S. but worldwide that share his interest in preventing medication error. For the U.S., SMPC will normally have a complement of anywhere from 20 to 25 dispensing analysts as part of a qualitative primary research assessment.”

7. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 7 rxmark Responses to Panel Moderator  Question 9 (rxmark #5) Question  “Do you have objective measures or thresholds for establishing problematic name similarity”? Response  “To provide context, Interbrand Wood Healthcare has conducted over 1000 proposed pharmaceutical trademark evaluation studies over the past 25 years. Since 1991, over 400 of the studies were conducted by rxmark using the 10/10® model which incorporates the methodologies outlined here today. Within the model, we provide the error index, a dispensing assessment framework reflecting primary research and expert assessment. The error index employs a ten-point scale, resulting in a numerical assessment reflecting low risk, moderate risk or high risk of misprescription. In addition to an overall rating relative to the risk of misprescription, an individual rating is assigned for the approximately 10 dispensing factors that impact medication error, which is distinct from name similarity. Relative to the name, a rating is assigned for verbal (phonetic), visual (written) and perceptual similarity based on a combination of objective as well as subjective assessments. Relative to the respective product profiles, a rating is assigned for individual dispensing factors such as form, route of administration, dosing strength and regimen, etc. The ratings are assigned in the context of the benchmarks we have established. Beyond what I have just outlined reflecting the primary research and expert assessment, we also employ a fairly sophisticated computer-based analytical tool to identify similar names and determine the degree of similarity to assist with our overall assessment.

8. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 8 rxmark Presentation

9. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 9 Step 1: conflictfilter A set of preliminary screens to identify significant conflicts post-creative name development and pre- creative presentation The rxmark Pharmaceutical Trademark Validation Process Step 2: 10/10 Trademark Evaluation Model Comprehensive dispensing, regulatory and marketing assessment with qualitative and quantitative methodology/elements Step 3: rxpanel Online, asynchronous ‘threaded discussion’ providing primary qualitative research ‘Safety First’ Proposed nomenclature is pre-screened for potential dispensing conflicts using a computer- assisted decision analysis tool Combine Quantitative & Qualitative Assessment should reflect multiple data sets and independent opinion relative to the risk of medication error Dispensing Advisory Board Create an internal advisory board to provide independent assessment relative to safe medication practices and to reflect new trademark introductions Launch Project Start (Phase I or II)

10. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 1010 DISPENSING MARKETING REGULATORY ElementRespondentFocus phonetic index Research FieldworkPhonetic Communication visual index Research FieldworkVisual Communication error index ® Dispensing AnalysisDispensing Conflicts Verbal Velocity Linguistic ModelMemorability Cross Cultural rxmark AnalysisGlobal Suitability rxpersona Research FieldworkBrand Communication metanet rxmark AnalysiseCommerce USAN/WHO rxmark AnalysisGeneric/INN Conflicts FDA/EMEA rxmark AnalysisTrade Name Conflicts TM Registration Client/rxmark AnalysisTrademark Conflicts ‘The Power of Ten’  The 10/10® Trademark Evaluation Model

11. Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting :: FDA, ISMP, PMRA :: June 26th, 2003 1 Thank You