Risk Communication on Medicines and Driving:

Transcription

1 Risk Communication on Medicines and Driving: The use of pictograms based on a European categorization system Susana Monteiro¹, René Huiskes¹, Liset van Dijk², Julia van Weert³, Marlies Geurts¹, Han de Gier¹ ¹ Department of Pharmacotherapy and Pharmaceutical Care, University of Groningen, The Netherlands ² Netherlands Institute for Health Services Research (NIVEL), Utrecht, The Netherlands ³ Amsterdam School of Communication Research (ASCoR), University of Amsterdam, The Netherlands Session J06/FIP Congress Hyderabad,

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3 37 Institutions from 18 European Countries DRUID - Overview IP - EU 6th Framework-Programme Start: October, 15th, 2006 Duration: 48 Months (+12 months) Total Budget: ~ 26 Mio 17 EU Member States + Norway EU-funding: 19 Mio 7 co-operative Work Packages 3

4 Introduction Risk communication is a two way exchange of information, leading to a better understanding of risk. It can make use of visual aids, such as pictograms. Pictograms Evidence indicates that people want to be informed of the benefits and the risks associated with medicines (Kalsher M J, Wogalter M S and Racicot B M. Pharmaceutical container labels: enhancing perceptions with alternative designs and pictorials. International Journal of Industrial Ergonomics 1996, 18: 83-90). Pictograms have been shown to enhance comprehension and recall of information (Mansoor L, Dowse R. Effect of pictograms on readability of patient information materials. Ann Pharmacother 2003;37:1003 9). 4

5 Categorization of driving impairing medicines Evaluation of : - Effects on psychomotor performance and risk studies - Epidemiology studies - Frequency of undesirable effects (relevant to driving) Four categories (at the start of treatment): - No or negligible influence (category 0) - Minor influence (category I) - Moderate influence (category II) - Major influence (category III) Limitations: no categorization by dose, same categorization during treatment 5

6 DRUID pictogram Category I II III 6

7 Objectives To evaluate the effectiveness of a pictogram in communicating risk associated with driving impairing medicines to patients. To assess patients level of understanding, and intention to change behaviour when looking at various pictograms. 7

8 Methods Setting Dutch community pharmacy. Method Interview of patients visiting a community pharmacy who possess a driving license. Comparison between two pictograms: French system vs DRUID (with and without side-text). 9 different groups (G1 to G9) 30 patients per group 270 patients in total 8

9 Group 1 st pictogram 2 nd pictogram G I Be careful! Read the patient information leaflet before driving. Vs G II Be very careful! Don t drive without the advice of your GP or pharmacist. Vs G III Attention: danger! Do not drive. Seek medical advice before driving again. Vs 9

10 Group 1 st pictogram 2 nd pictogram G IV Vs Be careful! Read the patient information leaflet before driving. G V Vs Be very careful! Don t drive without the advice of your GP or pharmacist. G VI Vs Attention: danger! Do not drive. Seek medical advice before driving again. 10

11 Group 1 st pictogram 2 nd pictogram G VII Be careful! Read the patient information leaflet before driving. Vs Be careful! Read the patient information leaflet before driving. G VIII Be very careful! Don t drive without the advice of your GP or pharmacist. Vs Be very careful! Don t drive without the advice of your GP or pharmacist. G IX Attention: danger! Do not drive. Seek medical advice before driving again. Vs Attention: danger! Do not drive. Seek medical advice before driving again. 11

12 Results Patients characteristics Gender = 50.7% male Mean age = 48.4 yrs (SD = 14.4) Education level = 45.6% high level of education Frequency of driving / use of motor vehicles = 54.8% very often 12

13 Change in driving behaviour (N = 270; both pictograms) 78.5% likely to change behaviour 36.3% drive less frequently 40.7% wouldn t drive anymore 13

14 Patients likelihood to change their driving behaviour after looking at the pictograms 14

15 Preferred pictogram DRUID pictogram with and without side-text. 15

16 Preferred pictogram (by age group) Clarity Level of impairment 74.4% preference for DRUID 82.6% preference for DRUID 16

17 Strengths and Limitations + Different study groups for comparison + Structured interviews by one interviewer + Calculated number of respondents was reached - Study population was highly educated - Reported behaviour - One country 17

18 Conclusions Both DRUID and the French pictograms appeared to be effective in communicating risk. The majority of the respondents recognized the risk of driving while taking driving impairing medicines. 18

19 Respondents were willing to change their driving behaviour by driving less frequently. DRUID pictogram - direct correlation between the likelihood of changing driving behaviour and the level of impairment of a medicine. Preference for DRUID pictogram over the French one. DRUID pictogram can be used as an effective and useful way of communicating risk to patients and, therefore, can possibly be adopted by the European Union. 19

20 Thank you for your attention!!! 20