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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Use of social media

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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