CRICOS No. 00213J Presentation by Tanya Smyth ICADTS 2010, Oslo 22- 26 August 2010 Medication...

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


L E V E L 2


L E V E L 3

Attention, danger :


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


NIVEAU 2


NIVEAU 3


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


NIVEAU 2


NIVEAU 1


NIVEAU 2


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


NIVEAU 2


NIVEAU 3


NIVEAU 1


NIVEAU 2


NIVEAU 3


Perceived likelihood of being involved in a crash

(Queensland sample)

L E V E L 1

Be careful


L E V E L 2


L E V E L 3

Attention, danger :


L E V E L 1

Be careful


L E V E L 2


L E V E L 3

Attention, danger :


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


L E V E L 2


L E V E L 3

Attention, danger :


L E V E L 1

Be careful


L E V E L 2


L E V E L 3

Attention, danger :


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


NIVEAU 2


NIVEAU 3


NIVEAU 1


NIVEAU 2


NIVEAU 3


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

[email protected]

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 #


• 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


• 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


• 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

CRICOS No. 00213J Presentation by Tanya Smyth ICADTS 2010, Oslo 22- 26 August 2010 Medication...

Documents

Transcript of CRICOS No. 00213J Presentation by Tanya Smyth ICADTS 2010, Oslo 22- 26 August 2010 Medication...