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A study comparing the effectiveness of three warning labels on the package of driving-impairing medicines.

Emich, B., Dijk, L. van, Monteiro, S.P., Gier, J.J. de. A study comparing the effectiveness of three warning labels on the package of driving-impairing medicines. International Journal of Clinical Pharmacy: 2014, 36(6), p. 1152-1159.
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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 drivingimpairing 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)] x 3 [category of drivingimpairment: I = minor risk, II = moderate risk, III = severe risk] design was used. The category of drivingimpairment 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. (aut. ref.)