Screening Proprietary Drug Names for Similarities:

Research Design and Questionnaire Structure

.

Shari Diamond, J.D., Ph.D.Shari Diamond, J.D., Ph.D.

Northwestern UniversityNorthwestern University

June 26, 2003June 26, 2003

Challenges to Test Design

Products are not yet on the marketProducts are not yet on the market Difficulty of simulating conditions under Difficulty of simulating conditions under

which prescriptions are:which prescriptions are: writtenwritten delivered orallydelivered orally filled by pharmacists and hospital filled by pharmacists and hospital

personnelpersonnel

Expert Panels

Knowledgeable about currently marketed Knowledgeable about currently marketed drugsdrugs

Familiar with drug pairs that have generated Familiar with drug pairs that have generated errors errors

Can use source lists to generate potential Can use source lists to generate potential candidates with confusing name similaritycandidates with confusing name similarity

Tacit knowledgeTacit knowledge

But Limits on Ability of Experts to Predict Errors May generate “similars” that don’t pose a May generate “similars” that don’t pose a

threat threat May miss potential errors becauseMay miss potential errors because

E.g., may fail to generate E.g., may fail to generate mispronunciations that cause errormispronunciations that cause error

E.g., may not anticipate similarities E.g., may not anticipate similarities generated by handwritinggenerated by handwriting

Need to Test Expert Predictions

Individuals are often bad predictors of their Individuals are often bad predictors of their own (or others’) reactionsown (or others’) reactions

Testing phase gauging actual reactions is Testing phase gauging actual reactions is crucialcrucial Need sample drawn from relevant Need sample drawn from relevant

populationpopulation Responding to appropriate stimuli Responding to appropriate stimuli

Assume We Want to Test the Name Taxol Respondents are told they will see a series Respondents are told they will see a series

of drug names, one at a time.of drug names, one at a time. Some will be drugs currently on the market, Some will be drugs currently on the market,

and some will be drugs not yet available.and some will be drugs not yet available.

Procedures for Testing

Respondents will receive a set of handwritten drug Respondents will receive a set of handwritten drug names, one at a time, including (but not limited to) names, one at a time, including (but not limited to) TaxolTaxol Self-administration is possible if respondents Self-administration is possible if respondents

are hooked up to the Internetare hooked up to the Internet Can be timed exposure to reflect usual time Can be timed exposure to reflect usual time

spent in examining a prescriptionspent in examining a prescription Order of presentation of a series of names can Order of presentation of a series of names can

be rotated be rotated

Instructions:

You will be shown the names of several You will be shown the names of several drugs, one at a time.drugs, one at a time.

Some of these drugs may be currently on Some of these drugs may be currently on the market and some may not be.the market and some may not be.

For each drug, the name of the drug will be For each drug, the name of the drug will be followed by several questions.followed by several questions.

These questions will ask about your These questions will ask about your reactions to the drug name you just saw. 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 Please type in the name of the drug you just

saw.saw.

(What is the name of the drug?)(What is the name of the drug?) Have you seen this name before today?Have you seen this name before today? If yes, do you happen to recall what If yes, do you happen to recall what

condition(s) it is used to treat?condition(s) it is used to treat?

Other Cues

Testing name alone maximizes likelihood of name Testing name alone maximizes likelihood of name confusionconfusion

Other cues (e.g., dosage, directions for use) can Other cues (e.g., dosage, directions for use) can reduce itreduce it

In fact, best prevention of error is to provide In fact, best prevention of error is to provide multiple cues (e.g., both brand and generic names)multiple cues (e.g., both brand and generic names)

Including cues in screening tests may reduce Including cues in screening tests may reduce apparent likelihood of error, but won’t reflect apparent likelihood of error, but won’t reflect reality if cues are inconsistently providedreality 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 is shown the new drug. The respondent then views a line-up of The respondent then views a line-up of

pharmaceutical products (or a picture of pharmaceutical products (or a picture of them) and is asked:them) and is asked:

“Line-up” Instructions

The drug whose name you were just The drug whose name you were just shown may or may not be displayed here.shown may or may not be displayed here.

Please indicate whether or not it is in the Please indicate whether or not it is in the display.display.

If it is, please indicate which number it is.If it is, please indicate which number it is.

Caveats With The Line-up Approach Despite instruction, need to control for Despite instruction, need to control for

guessingguessing Reserve for:Reserve for:

situations where similarly named drugs situations where similarly named drugs are likely to be stored side by sideare likely to be stored side by side

When Should the Questions Be Closed-Ended? IT DEPENDS Not when testing for comprehension/recall Not when testing for comprehension/recall

of name of name Potentially in providing list of condition(s) Potentially in providing list of condition(s)

the drug may be used to treat the drug may be used to treat Line-up is essentially a multiple-choice Line-up is essentially a multiple-choice

question – a recognition taskquestion – a recognition task

Focus Groups as a Substitute?

Good for generating ideas (the expert panel)Good for generating ideas (the expert panel) Weak for evaluating individual reactions to Weak for evaluating individual reactions to

specific stimulispecific stimuli Interdependence of responses from group Interdependence of responses from group

members – Low Nmembers – Low N Crucial role of moderatorCrucial role of moderator

Problems in Validating

One-sided and potentially incomplete One-sided and potentially incomplete feedback:feedback: Are approvals followed or not followed Are approvals followed or not followed

by reported medical errors?by reported medical errors? But disapprovals never testedBut disapprovals never tested

Future

Computerized communication (no Computerized communication (no handwriting problems)handwriting problems)

Bar codes to permit computer reading of Bar codes to permit computer reading of prescriptionsprescriptions

In the present,In the present,

need to proceed with caution need to proceed with caution