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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
•
•
•
•
•
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
• 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
Longo, Hunter, Lokan, White & White, 2000; O’Hanlon & Ramaekers, 1995
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
1
2
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
French
English translation
Soyez prudent
Ne pas conduire sans avoir
lu la notice
LEVEL 1
NIVEAU 1
Soyez très prudent
Be very careful
Ne pas conduire sans l’avis
d’un professionnel de santé
Do not drive without the
advice of a health
professional
NIVEAU 2
NIVEAU 3
Be careful
Do not drive without
having read the notice
LEVEL 2
Attention, danger :
Ne pas conduire
Attention, danger :
do not drive
Pour la reprise de la conduite,
demandez l’avis d’un médecin
Before returning to the wheel,
seek the advice of a doctor
LEVEL 3
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
and Braun, 1999
8 Silver
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
Ne pas conduire sans avoir
lu la notice
NIVEAU 1
Soyez très prudent
Ne pas conduire sans ’avis
l
d’un professionnel de santé
NIVEAU 2
Attention, danger :
Ne pas conduire
NIVEAU 3
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:
Soyez prudent
– Wilcoxon significance test (non-parametric)
Ne pas conduire sans avoir
lu la notice
NIVEAU 1
• Potential chance of having a crash, z = -11.87, p < .001 (n = 322)
Soyez très
prudent (n = 325)
• Potential impairment to driving ability, z = -13.26,
p <.001
Ne pas conduire sans l’avis
d’un professionnel de santé
NIVEAU 2
Attention, danger :
Ne pas conduire
NIVEAU 3
Pour la reprise de la conduite,
demandez l’avis d’un médecin
Perceived likelihood of being
involved in a crash
(Queensland sample)
60.0
Queensland
label
Be careful
Percent of responses
50.0
LEVEL 1
Do not drive without
having read the notice
40.0
Be very careful
Do not drive without the
advice of a health
professional
French label
LEVEL 2
30.0
Attention, danger :
do not drive
LEVEL 3
Before returning to the wheel,
seek the advice of a doctor
20.0
General
10.0
.0
1
2
Very unlikely
3
4
5
6
7
8
9
10
Very likely
Perceived impairment associated
with warning label
(Queensland sample)
60.0
Percent of responses
50.0
Queensland label
40.0
LEVEL 1
Be careful
Do not drive without
having read the notice
Be very careful
30.0
Do not drive without the
advice of a health
professional
French label
LEVEL 2
Attention, danger :
do not drive
20.0
LEVEL 3
10.0
.0
1
2
3
Slightly impaired
4
5
6
7
8
9
10
Very impaired
Before returning to the wheel,
seek the advice of a doctor
Implications
• Evidence suggests:
Soyez prudent
Ne pas conduireon
sansmedications
avoir
– Warnings about driving displayed
can influence
lu la notice
risk perceptions associated with use of the medication
– The French Level-3 warning is associated with stronger
Soyez très prudent
perceptions of risk than theNe pas
current
QLD mandatory warning
conduire sans l’avis
NIVEAU 1
d’un professionnel de santé
NIVEAU 2
Attention, danger :
Ne pas conduire
NIVEAU 3
Pour 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, 1999
Silver and Braun, 1999
10
Questions?
[email protected]
Mark your Diaries!
International Council on Alcohol, Drugs and Traffic Safety
Conference (ICADTS T2013)
August 2013, Brisbane Convention and Exhibition Centre
Examples polydrug use – QLD sample
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