medication warnings about driving: risk perceptions among french and australian communities
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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: - PowerPoint PPT PresentationTRANSCRIPT
CRICOS No. 00213J
Presentation by Tanya SmythICADTS 2010, Oslo
22- 26 August 2010
Medication warnings about driving: risk perceptions among French and Australian communities
Acknowledgements
• Supervisors– France:
• Dr Charles Mercier-Guyon, Dr Michel Mallaret
– Australia:• Em Prof Mary Sheehan, Prof Vic Siskind, Prof Ian Shochet
• Pharmacovigilance Centre, 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
1 Longo, Hunter, Lokan, White & White, 2000; O’Hanlon & Ramaekers, 19952 Barbone et al., 1998; Drummer, Gerostamoulos, Batziris, Chu, Caplehorn & Robertson, 2004;
Mura et al., 2003; Neutel, 1995, 1998; Ray, 1996; Ray, Fought & Decker, 19923 Longo et al., 20004 de Gier, 2006; Neutel, 19955 Ramaekers, Ansseau, Muntiewerff, Sweens & O’Hanlon, 1996
• 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
• 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
Drug impaired driving – AustraliaRisk perceptions and behaviour
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
• National scheduling of medicines and guidelines for warnings • Label characteristics differ between States/Territories
Medication warnings – QLD
• One mandatory sedation warning label
• Other regulated labels are at pharmacists’ discretion
– 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 – QLD
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
L E V E L 1
Be careful
Do not drive without having read the notice
L E V E L 2
Be very carefulDo not drive without the advice of a health professional
L E V E L 3
Attention, danger :
do not driveBefore returning to the wheel, seek the advice of a doctor
L E V E L 1
Be careful
Do not drive without having read the notice
L E V E L 2
Be very carefulDo not drive without the advice of a health professional
L E V E L 3
Attention, danger :
do not driveBefore returning to the wheel, seek the advice of a doctor
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduirePour la reprise de la conduite, demandez l’avis d’un médecin
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduirePour la reprise de la conduite, demandez l’avis d’un médecin
French English translation
Warning labels What influence can they have?
7 Kalsher and Williams, 20068 Silver and Braun, 1999
• Influence risk perceptions– Perceived likelihood and/or severity of injury7
– Risk perceptions may then influence compliance behaviour8
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
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduire
Pour la reprise de la conduite, demandez l’ avis d’un médecinNIVEAU 3
Attention, danger :Ne pas conduire
Pour la reprise de la conduite, demandez l’ avis d’un médecin
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)
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduirePour la reprise de la conduite, demandez l’avis d’un médecin
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduirePour la reprise de la conduite, demandez l’avis d’un médecin
Perceived likelihood of being involved in a crash
(Queensland sample)
L E V E L 1
Be careful
Do not drive without having read the notice
L E V E L 2
Be very carefulDo not drive without the advice of a health professional
L E V E L 3
Attention, danger :
do not driveBefore returning to the wheel, seek the advice of a doctor
L E V E L 1
Be careful
Do not drive without having read the notice
L E V E L 2
Be very carefulDo not drive without the advice of a health professional
L E V E L 3
Attention, danger :
do not driveBefore returning to the wheel, seek the advice of a doctor
Very unlikely Very likely
Per
cen
t of
res
pons
es
Perceived impairment associated with warning label
(Queensland sample)
L E V E L 1
Be careful
Do not drive without having read the notice
L E V E L 2
Be very carefulDo not drive without the advice of a health professional
L E V E L 3
Attention, danger :
do not driveBefore returning to the wheel, seek the advice of a doctor
L E V E L 1
Be careful
Do not drive without having read the notice
L E V E L 2
Be very carefulDo not drive without the advice of a health professional
L E V E L 3
Attention, danger :
do not driveBefore returning to the wheel, seek the advice of a doctor
Slightly impaired Very impaired
Per
cen
t of
res
pons
es
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
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduirePour la reprise de la conduite, demandez l’avis d’un médecin
NIVEAU 1
Soyez prudentNe pas conduire sans avoir lu la notice
NIVEAU 2
Soyez très prudentNe pas conduire sans l’avis d’un professionnel de santé
NIVEAU 3
Attention, danger :Ne pas conduirePour la reprise de la conduite, demandez l’avis d’un médecin
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, 199910 Silver and Braun, 1999
Mark your Diaries!
International Council on Alcohol, Drugs and Traffic Safety Conference (ICADTS T2013)
August 2013, Brisbane Convention and Exhibition Centre
Gender Male Gender Male
Age 71 – 80 Age 21 - 30
Drive regularly?
Yes Drive regularly?
Yes
Operate machinery?
No Operate machinery?
Yes
Medication class (warning labels)
• Narcotic analgesic #• Simple analgesic• Antiangina agent• Hypolipidaemic agent• Antidepressant #• Antihypertensive agent #• NSAID #
Medication class (warning labels)
• Narcotic analgesic1 #• Narcotic analgesic2 #• Antidepressant #• Antihypertensive agent #
Dose / frequency
Daily (all) Dose / frequency
Daily (all)
Alcohol? Daily Alcohol? Occasionally
Illicit drugs? No Illicit drugs? Cannabis (daily)Ecstasy (occasionally)Cocaine (at least once)
Examples polydrug use – QLD sample
Gender Male Gender Male
Age 71 - 80 Age 41 - 50
Drive regularly?
Yes Drive regularly?
Yes
Operate machinery?
No Operate machinery?
No
Medication class (warning labels)
• Immunomodifier• Adrenal steroid hormone• Hypolipidaemic agent• Antipsychotic agent #• Antidepressant #• Antihypertensive agent 1 #• Antihypertensive agent 2 #• Beta-adrenergic blocking agent #• Gout/hyperuricaemia agent #• Calcium/bone metabolism agent
Medication class (warning labels)
• Narcotic analgesic1 #• Narcotic analgesic2 #• Narcotic analgesic3 #• Antidepressant #
Dose / frequency
Daily (all) Dose / frequency
Daily (all)
Alcohol? Daily Alcohol? Occasionally
Illicit drugs? No Illicit drugs? No
Examples polydrug use – QLD sample