Rivista di formazione e aggiornamento professionale del pediatra e del medico di base, fondata nel 1982. In collaborazione con l'Associazione Culturale Pediatri.
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L’importanza dei case report in farmacovigilanza

THE IMPORTANCE OF CASE REPORTS IN PHARMACOVIGILANCE

Mauro Venegoni

Già responsabile del Servizio di Farmacovigilanza, Agenzia Italiana del Farmaco (AIFA)

Ottobre 2009 - pagg. 501 -507

LE REAZIONI AVVERSE AI FARMACI IN ETÀ PEDIATRICA
Abstract
The publication of case reports is one of the useful didactic instrument to disseminate the knowledge on many or very rare adverse reactions that physicians must know whenever they make prescriptions. Moreover, the activity of pharmacovigilance and the recommendations that have to follow certain rules are an indispensable collaboration tool by the physicians for the drug regulatory agencies.
Parole chiave
ADR Case report Paediatrics Pharmacovigilance
Suggerite dall'AI
adverse reaction reazione avversa
Classificazione MeSH
Health Care Facilities Workforce and Services Health Services Pharmaceutical Services Drug Information Services Adverse Drug Reaction Reporting Systems (10)
Diagnosis Diagnostic Techniques and Procedures Monitoring, Physiologic Drug Monitoring (8)
Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions (116)
Investigative Techniques Evaluation Studies as Topic Product Surveillance, Postmarketing Pharmacovigilance (24)
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Bibliografia
1. Sridhar AR, Willett LL, Castiglioni A, et al. Scholarship opportunities for trainees and clinician educators: learning outcomes from a case report writing workshop. J Gen Intern Med 2009;24:398-401.
2. Avorn J. Paying for drug approvals - who’s using whom? N Engl J Med 2007;356:1697- 700.
3. Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Pharmacoepidemiol Drug Saf 2007;16:581-7.

Corrispondenza: m.venegoni@aifa.gov.it