BACKGROUND: Several medicines are known to potentially impair patients' driving fitness. Appropriate communication towards patients about this risk can be supported by the use of package warning labels. OBJECTIVE: To compare the effectiveness of a standing practice yellow/black label-with written warning-with a newly developed rating model in communicating risk on driving-impairing medicines (DIMs). Furthermore, the added value of a side-text in the rating model was determined. SETTING: Community pharmacies in the Netherlands. METHOD: In a cross-sectional study, patients with a first dispensing of a DIM were asked by their community pharmacists (n = 38) to fill out a written questionnaire to compare each of the three warning labels. A 2 [yellow/black label vs. rating model (pair 1) and rating model with side-text vs. rating model without side-text (pair 2)] × 3 [category of driving-impairment: I = minor risk, II = moderate risk, III = severe risk] design was used. The category of driving-impairment varied per respondent, depending on the DIM the patient collected. MAIN OUTCOME MEASURE: (1) estimated level of driving risk valued by patients (2) intention to change driving behaviour after seeing the warning label. RESULTS: An estimated number of 992 patients were approached. As 298 questionnaires were analysed, the net response rate was 30%. With the yellow/black label, respondents considered DIMs of all three categories of driving-impairment to equally impair driving fitness, while with the rating model the estimated risk was higher when the category referred to a higher level of driving-impairment. Addition of a side-text to the rating model resulted in a significantly higher estimated level of driving risk and a significant increase in intention to change driving behaviour. Only 8.0% of the patients using a category III DIM estimated the level of driving risk correctly when seeing the yellow/black label, while this was 26.7% for the rating model and 43.0% for the rating model with side-text. CONCLUSION: The yellow/black label, which is standing practice in the Netherlands, is less effective in terms of estimated risk and intention to change driving behaviour, compared to a newly developed rating model. This model is even more effective when a side-text is added. Implementation of the rating model in clinical practice should be considered.
BACKGROUND: Several medicines are known to potentially impair patients' driving fitness. Appropriate communication towards patients about this risk can be supported by the use of package warning labels. OBJECTIVE: To compare the effectiveness of a standing practice yellow/black label-with written warning-with a newly developed rating model in communicating risk on driving-impairing medicines (DIMs). Furthermore, the added value of a side-text in the rating model was determined. SETTING: Community pharmacies in the Netherlands. METHOD: In a cross-sectional study, patients with a first dispensing of a DIM were asked by their community pharmacists (n = 38) to fill out a written questionnaire to compare each of the three warning labels. A 2 [yellow/black label vs. rating model (pair 1) and rating model with side-text vs. rating model without side-text (pair 2)] × 3 [category of driving-impairment: I = minor risk, II = moderate risk, III = severe risk] design was used. The category of driving-impairment varied per respondent, depending on the DIM the patient collected. MAIN OUTCOME MEASURE: (1) estimated level of driving risk valued by patients (2) intention to change driving behaviour after seeing the warning label. RESULTS: An estimated number of 992 patients were approached. As 298 questionnaires were analysed, the net response rate was 30%. With the yellow/black label, respondents considered DIMs of all three categories of driving-impairment to equally impair driving fitness, while with the rating model the estimated risk was higher when the category referred to a higher level of driving-impairment. Addition of a side-text to the rating model resulted in a significantly higher estimated level of driving risk and a significant increase in intention to change driving behaviour. Only 8.0% of the patients using a category III DIM estimated the level of driving risk correctly when seeing the yellow/black label, while this was 26.7% for the rating model and 43.0% for the rating model with side-text. CONCLUSION: The yellow/black label, which is standing practice in the Netherlands, is less effective in terms of estimated risk and intention to change driving behaviour, compared to a newly developed rating model. This model is even more effective when a side-text is added. Implementation of the rating model in clinical practice should be considered.
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