Screening Proprietary Drug Names for Similarities: Research Design and Questionnaire Structure .

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

Screening Proprietary Drug Names for Similarities: Research Design and Questionnaire Structure .