Transcript Document 7650066

Screening Proprietary Drug
Names for Similarities:
Research Design and
Questionnaire Structure
.
Shari Diamond, J.D., Ph.D.
Northwestern University
June 26, 2003
Challenges to Test Design
Products are not yet on the market
 Difficulty of simulating conditions under
which prescriptions are:
 written
 delivered orally
 filled by pharmacists and hospital
personnel

Expert Panels
Knowledgeable about currently marketed
drugs
 Familiar with drug pairs that have generated
errors
 Can use source lists to generate potential
candidates with confusing name similarity
 Tacit knowledge

But Limits on Ability of Experts
to Predict Errors
May generate “similars” that don’t pose a
threat
 May miss potential errors because
 E.g., may fail to generate
mispronunciations that cause error
 E.g., may not anticipate similarities
generated by handwriting

Need to Test Expert Predictions
Individuals are often bad predictors of their
own (or others’) reactions
 Testing phase gauging actual reactions is
crucial
 Need sample drawn from relevant
population
 Responding to appropriate stimuli

Assume We Want to Test the
Name Taxol
Respondents are told they will see a series
of drug names, one at a time.
 Some will be drugs currently on the market,
and some will be drugs not yet available.

Procedures for Testing

Respondents will receive a set of handwritten drug
names, one at a time, including (but not limited to)
Taxol
 Self-administration is possible if respondents
are hooked up to the Internet
 Can be timed exposure to reflect usual time
spent in examining a prescription
 Order of presentation of a series of names can
be rotated
Instructions:
You will be shown the names of several
drugs, one at a time.
 Some of these drugs may be currently on
the market and some may not be.
 For each drug, the name of the drug will be
followed by several questions.
 These questions will ask about your
reactions to the drug name you just saw.

Questions Asked After Each
Name Is Shown:
Please type in the name of the drug you just
saw.
(What is the name of the drug?)
 Have you seen this name before today?
 If yes, do you happen to recall what
condition(s) it is used to treat?

Other Cues




Testing name alone maximizes likelihood of name
confusion
Other cues (e.g., dosage, directions for use) can
reduce it
In fact, best prevention of error is to provide
multiple cues (e.g., both brand and generic names)
Including cues in screening tests may reduce
apparent likelihood of error, but won’t reflect
reality if cues are inconsistently provided
A Potential Approach When the
Expert Panel Identifies A
Particular Similarly Named Drug

The respondent is shown the new drug.
 The respondent then views a line-up of
pharmaceutical products (or a picture of
them) and is asked:
“Line-up” Instructions
The drug whose name you were just
shown may or may not be displayed here.
 Please indicate whether or not it is in the
display.
 If it is, please indicate which number it is.

Caveats With The Line-up
Approach
Despite instruction, need to control for
guessing
 Reserve for:
 situations where similarly named drugs
are likely to be stored side by side

When Should the Questions Be
Closed-Ended? IT DEPENDS
Not when testing for comprehension/recall
of name
 Potentially in providing list of condition(s)
the drug may be used to treat
 Line-up is essentially a multiple-choice
question – a recognition task

Focus Groups as a Substitute?
Good for generating ideas (the expert panel)
 Weak for evaluating individual reactions to
specific stimuli
 Interdependence of responses from group
members – Low N
 Crucial role of moderator

Problems in Validating

One-sided and potentially incomplete
feedback:
 Are approvals followed or not followed
by reported medical errors?
 But disapprovals never tested
Future
Computerized communication (no
handwriting problems)
 Bar codes to permit computer reading of
prescriptions


In the present,
need to proceed with caution