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Medication warnings about driving: risk perceptions among French and Australian communities. Presentation by Tanya Smyth ICADTS 2010, Oslo 22- 26 August 2010. CRICOS No. 00213J. Acknowledgements. Supervisors France: Dr Charles Mercier-Guyon, Dr Michel Mallaret Australia:
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Medication warnings about driving: risk perceptions among French and Australian communities Presentation by Tanya Smyth ICADTS 2010, Oslo 22- 26 August 2010 CRICOS No. 00213J
Acknowledgements • Supervisors • France: • Dr Charles Mercier-Guyon, Dr Michel Mallaret • Australia: • Em Prof Mary Sheehan, Prof Vic Siskind, Prof Ian Shochet • PharmacovigilanceCentre, Grenoble • Grenoble Hospital • DRUID • NHMRC • NRMA
Overview • Background • Medications and crash risk • Drug impaired driving – Australia • Risk perceptions and behaviour • The role of warnings • Current warnings – QLD and France • Research aims • Method • Results • Risk perceptions according to warning label (QLD sample) • Impairment • Chance of having a crash • Implications and limitations
Medications and crash risk • Increased crash risk associated with use of sedative medications1: • e.g., Benzodiazepines, sedative antihistamines, tricyclic antidepressants2 • Even at therapeutic concentrations3 • Dose effects (start of treatment, increased dose)4 • When combined with other medications5 • When combined with alcohol and illicit drugs5 1 Longo, Hunter, Lokan, White & White, 2000; O’Hanlon & Ramaekers, 1995 2 Barbone et al., 1998; Drummer, Gerostamoulos, Batziris, Chu, Caplehorn & Robertson, 2004; Mura et al., 2003; Neutel, 1995, 1998; Ray, 1996; Ray, Fought & Decker, 1992 3 Longo et al., 2000 4 de Gier, 2006; Neutel, 1995 5 Ramaekers, Ansseau, Muntiewerff, Sweens & O’Hanlon, 1996
Drug impaired driving – Australia Risk perceptions and behaviour • Research by Australian Drug Foundation6 • Pharmaceutical drugs perceived as less impairing than illicit drugs or alcohol6 • Polydrug use is predominant pattern of use in Australia6 • Respondents reported driving within 3 hours of taking: • Analgesics (44.8%) • Prescription stimulants (43%) • Benzodiazepines (30.3%) • Users perceive less risk than non-users6 6 Mallick et al., 2007
The role of warning labels • Most information on pharmaceutical drugs and driving is given when medication is dispensed • Warning labels • Consumer medicines information (CMIs) • Verbal advice from pharmacist • Australian research findings6: • People often do not read the warnings • Need for research to investigate the effectiveness of warning labels • Comparison of two different approaches (QLD and French) to determine if there are any benefits of the French system that QLD can adopt 6 Mallick et al., 2007
Medication warnings – QLD • National scheduling of medicines and guidelines for warnings • Label characteristics differ between States/Territories • One mandatory sedation warning label • Other regulated labels are at pharmacists’ discretion
Medication warnings – QLD • Strengths: • Alerts the patient to take care • Visible in the situation of use • Warns of effect of alcohol • Weaknesses: • Small text (elderly have difficulty reading it) • People often don’t read them • Requires the user to self-assess their impairment
Medication warnings – France • Introduced new warning labels in 2005: • Visual system of grading • Pictogram to alert to driving risk • Use of colour to indicate level • Indication of the level of risk • Level 1, Level 2, Level 3 • Warning message and advice on driving • Seek advice from a health professional
Warning labels What influence can they have? • Influence risk perceptions • Perceived likelihood and/or severity of injury7 • Risk perceptions may then influence compliance behaviour8 7 Kalsher and Williams, 2006 8 Silver and Braun, 1999
Research aims • Overall research aim: • How do our labels in Queensland perform? • Comparison of QLD and updated French approach • Conducted to complement the work of DRUID in reviewing the effectiveness of existing campaigns and practice guidelines • Aims of this study: • Establish and compare risk perceptions associated with the Queensland and French warnings among medication users
Methodology • Participants • Medication users who drive regularly • France (N=75, n=39 Male, n=33 Female, n=3 unreported) • Queensland (N=358, n=186 Male, n=165 Female, n=7 unreported) • Materials • Written self-report survey • Key variables: • Perceptions of French and QLD warning labels • Both samples assessed for perceptions of the warning that carried the strongest message of risk • QLD study included perceptions of the likelihood of crash and level of impairment associated with the warning • Procedure • Surveyed at participating metropolitan public hospital pharmacies in QLD and France
Results • When all QLD and French labels were compared, the majority of the French and Queensland samples perceived the French Level-3 label as the strongest warning about risk concerning driving Soyez prudent Soyez prudent Ne pas conduire sans avoir Ne pas conduire sans avoir lu la notice lu la notice NIVEAU 1 NIVEAU 1 Soyez tr Soyez tr è è s prudent s prudent Ne pas conduire sans l Ne pas conduire sans l ’ ’ avis avis d d ’ ’ un professionnel de sant un professionnel de sant é é NIVEAU 2 NIVEAU 2 Attention, danger : Attention, danger : Ne pas conduire Ne pas conduire Pour la reprise de la conduite, Pour la reprise de la conduite, demandez l demandez l ’ ’ avis d avis d ’ ’ un m un m é é decin decin NIVEAU 3 NIVEAU 3
Results – QLD sample • Significantly stronger perceptions of risk after taking medication with the strongest French warning, compared with the strongest QLD warning: • Wilcoxon significance test (non-parametric) • Potential chance of having a crash, z = -11.87, p < .001 (n = 322) • Potential impairment to driving ability, z = -13.26, p <.001 (n = 325)
Perceived likelihood of being involved in a crash(Queensland sample) Percent of responses Very likely Very unlikely
Perceived impairment associated with warning label(Queensland sample) Percent of responses Very impaired Slightly impaired
Implications • Evidence suggests: • Warnings about driving displayed on medications can influence risk perceptions associated with use of the medication • The French Level-3 warning is associated with stronger perceptions of risk than the current QLD mandatory warning
Limitations • Sample size from French study • Future research using larger sample • Design • Case/control and/or randomised trials • Difficult in context of medication and labelling
Future research • Can these risk perceptions influence behaviour? • Research suggests that people are more likely to be cautious when perceived risk increases9 • Existing literature suggests increased perceived risk is associated with increased compliance with a warning10 9 Wogalter, Young, Brelsford & Barlow, 1999 10 Silver and Braun, 1999
Questions? t.smyth@qut.edu.au Mark your Diaries! International Council on Alcohol, Drugs and Traffic Safety Conference (ICADTS T2013) August 2013, Brisbane Convention and Exhibition Centre