# Presentation: 180600

## 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