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A plea for a more epidemiological and patient-oriented pharmacovigilance
Veronica Scurti1, Marilena Romero, Gianni Tognoni
1Department of Clinical Pharmacology and Epidemiology, Centro Studi SIFO, Consorzio Mario Negri Sud, Via Nazionale 8/a, 66030, S. Maria Imbaro, Italy. scurti@negrisud.it
European Journal of Clinical Pharmacology
|July 21, 2011
Summary
This study reviews pharmacovigilance history, advocating a shift from drug-focused to patient-centered safety monitoring. It highlights the need to consider real-world contexts for comprehensive drug benefit-risk assessment.
Area of Science:
- Pharmacovigilance and Drug Safety
- Public Health
- Regulatory Science
Background:
- The history of pharmacovigilance reveals evolving methodologies and legislation.
- Recurrent drug-related emergencies question current surveillance efficacy and regulatory roles.
Observation:
- Drugs must be evaluated within their real-world usage contexts.
- Contextual factors significantly impact drug efficacy, tolerability, and safety.
Findings:
- Pharmacovigilance requires a transition from a drug-centered to a patient/population-centered approach.
- Patient and population participation is crucial for knowledge generation in drug safety.
Implications:
- Evolving surveillance to assess the societal benefit/risk profile of drugs.
- Integrating patient-generated knowledge to enhance drug safety monitoring.
- Moving beyond controlling adverse reactions to comprehensive benefit-risk evaluation.
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