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rxmark is the division of Interbrand Wood Healthcare providing proprietary research methodologies an

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Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting : ... Relative to the name, a rating is assigned for verbal (phonetic), visual ... – PowerPoint PPT presentation

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Title: rxmark is the division of Interbrand Wood Healthcare providing proprietary research methodologies an


1
Evaluating Names for Similarities Methods and
ApproachesPublic MeetingFood and Drug
AdministrationInstitute for Safe Medication
PracticesPharmaceutical Research and
Manufacturers of AmericaJune 26th, 2003
  • 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.com rxmark_at_interbrandwood.com
    212.739.9670

2
Responses to the Panel Moderator
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 hospitalonly 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
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
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
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
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
rxmark Presentation
9
The rxmark Pharmaceutical Trademark Validation
Process
Project Start (Phase I or II)
Step 2 10/10 Trademark Evaluation Model
Comprehensive dispensing, regulatory and
marketing assessment with qualitative and
quantitative methodology/elements
Dispensing Advisory Board
Create an internal advisory board to provide
independent assessment relative to safe
medication practices and to reflect new trademark
introductions
Launch
10
The Power of Ten ? The 10/10 Trademark
Evaluation Model
Element
Respondent
Focus
DISPENSING
MARKETING
REGULATORY
11
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