1. Screening Proprietary Drug Names for Similarities: Research Design and Questionnaire Structure. Shari Diamond, J.D., Ph.D. Northwestern University June 26, 2003

2. Challenges to Test Design Products are not yet on the market Products are not yet on the market Difficulty of simulating conditions under which prescriptions are: Difficulty of simulating conditions under which prescriptions are:  written  delivered orally  filled by pharmacists and hospital personnel

3. Expert Panels Knowledgeable about currently marketed drugs Knowledgeable about currently marketed drugs Familiar with drug pairs that have generated errors Familiar with drug pairs that have generated errors Can use source lists to generate potential candidates with confusing name similarity Can use source lists to generate potential candidates with confusing name similarity Tacit knowledge Tacit knowledge

4. But Limits on Ability of Experts to Predict Errors May generate “similars” that don’t pose a threat May generate “similars” that don’t pose a threat May miss potential errors because May miss potential errors because  E.g., may fail to generate mispronunciations that cause error  E.g., may not anticipate similarities generated by handwriting

5. Need to Test Expert Predictions Individuals are often bad predictors of their own (or others’) reactions Individuals are often bad predictors of their own (or others’) reactions Testing phase gauging actual reactions is crucial Testing phase gauging actual reactions is crucial  Need sample drawn from relevant population  Responding to appropriate stimuli

6. Assume We Want to Test the Name Taxol Respondents are told they will see a series of drug names, one at a time. 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. Some will be drugs currently on the market, and some will be drugs not yet available.

7. Procedures for Testing Respondents will receive a set of handwritten drug names, one at a time, including (but not limited to) Taxol 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

8. Instructions: You will be shown the names of several drugs, one at a time. 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. 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. 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. These questions will ask about your reactions to the drug name you just saw.

9. Questions Asked After Each Name Is Shown: Please type in the name of the drug you just saw. 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? Have you seen this name before today? If yes, do you happen to recall what condition(s) it is used to treat? If yes, do you happen to recall what condition(s) it is used to treat?

10. Other Cues Testing name alone maximizes likelihood of name confusion Testing name alone maximizes likelihood of name confusion Other cues (e.g., dosage, directions for use) can reduce it 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) 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 Including cues in screening tests may reduce apparent likelihood of error, but won’t reflect reality if cues are inconsistently provided

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

12. “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.

13. Caveats With The Line-up Approach Despite instruction, need to control for guessing Despite instruction, need to control for guessing Reserve for: Reserve for:  situations where similarly named drugs are likely to be stored side by side

14. When Should the Questions Be Closed-Ended? IT DEPENDS Not when testing for comprehension/recall of name Not when testing for comprehension/recall of name Potentially in providing list of condition(s) the drug may be used to treat 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 Line-up is essentially a multiple-choice question – a recognition task

15. 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 specific stimuli Weak for evaluating individual reactions to specific stimuli  Interdependence of responses from group members – Low N  Crucial role of moderator

16. Problems in Validating One-sided and potentially incomplete feedback: One-sided and potentially incomplete feedback:  Are approvals followed or not followed by reported medical errors?  But disapprovals never tested

17. Future Computerized communication (no handwriting problems) Computerized communication (no handwriting problems) Bar codes to permit computer reading of prescriptions Bar codes to permit computer reading of prescriptions In the present, In the present, need to proceed with caution need to proceed with caution