Another perspective in pharmacovigilance -...
Transcript of Another perspective in pharmacovigilance -...
Eugène van Puijenbroek, MD, PhD, clinical pharmacologist
Another perspective in pharmacovigilance
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The importance of pharmacovigilance, 2002
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An adverse reaction is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from: • the use of a medicinal product within the terms of the marketing authorisation; • the use outside the terms of the marketing authorisation, including overdose, off-label use, misuse, abuse and medication errors; • occupational exposure.
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Who uses our information?
•! Regulatory agencies
•! Approval of drugs for marketing
•! Healthcare professionals
•! Patients
Widening the scope of pharmacovigilance
•! Stronger focus on non-serious ADRs
•! Information characterising occurrence of ADRs -! Risk factors
-! Time course, duration outcome
-! Circumstances under which ADRs occur
-! Behaviour towards ADRs
Clinical characteristics
Attitude and behaviour
Serious and non-serious ADRs
Information characterising ADRs
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Before During ADR Afterwards
Clinical aspects Risk factors, among which genetic polymorphisms and Co-morbidity and concomitant medication
Clinical symptoms Course of reaction Impact QOL
Outcome Sequellae
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Visit GP What do others expect from him?
Feasible to visit GP Practical circumstances
Treatment desired? Bad experience?
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Continue or stop treatment?
What do others expect from him?
Can I stop using the drug?
Treatment desired? Risk/benefit? Previous experiences?
Healthcare professional
Before During ADR Afterwards
Attitude and
subjective norms
Risk perception Acquiring knowledge on ADRs
Cautiousness Previous experience
Experience
Behavior Educational activities Adherence to guidelines Medication errors Off-label prescribing
Diagnostics Treatment of ADRs
Preventive measures Note contraindications Reporting ADRs
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Patient Before During ADR Afterwards
Attitude and
subjective norms
Risk perception Feeling of control
Level of acceptance Coping ability
Experience
Behaviour Adherence Off-label use Drug misuse or abuse Reading the SmPC Use of social media
Consumption of care Absenteeism from work
Consumption of care Absenteeism Adherence to future treatment
Can current data sources be used for studying the characterises of ADRs?
Type of reporters
•! Healthcare professionals
•! Patients
•! Nurses and nurse practitioners
•! Paramedical personnel
Healthcare professional as source of information
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Can current signal detection techniques be used for studying the characterisitics of ADRs?
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Pacurariu et al., Druf Saf 2014;37:1059-66
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Broos et a. Drug Saf 2010: 33(12): 1109-1115
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Broos et a. Drug Saf 2010: 33(12): 1109-1115
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Disproportionality analysis
Case by case
•! Value of the individual report •! Frame of reference: experience of
reporter and assessor •! Signal refers to the selected cases •! Causal relationship
Disproportionality analysis •! All reports contribute ‘equally’ •! Frame of reference: (part of) dataset •! Signal also refers to other reports in the
dataset •! Statistical dependency
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In conclusion
free after Burgers, D.J. Ned Tijdschr Geneeskd. 2015;159: A8376
Demand driven information
Practice driven information
Evidence based driven information on drug-ADR
True pharmacovigilance
Another perspective..
Thank you for your attention!
Statements
There is still a big gap between our knowledge of ADRs and their occurrence, course and impact on the lives of patients in daily practice.
A change to a more patient oriented approach in pharmacovigilance is needed