§ Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
§ Adverse drug reactions (ADRs) are frequently classified as…
¨ Type A (Augmented) reactions
¨ Type B (Bizarre) reactions
¨ Type C (Chronic) reactions
¨ Type D (Delayed) reactions
¨ Type E (End of use) reactions
§ Pharmacovigilance methodologies include…
¨ Passive drug Surveillance methodologies
o Spontaneous reports
¨ Active drug surveillance methodologies
o Enhanced spontaneous reporting
o Stimulated reporting through solicited reports
o Designated sentinel sites (sometimes referred to as geographic surveillance)
o Ad hoc assembly of a cohort of patients
o Systematic assembly of a cohort of patients
o Case-controlled surveillance (also called disease registries or disease-specific surveillance)
o Population-based surveillance
o Large automated multipurpose databases
§ Most ADRs can be prevented by following the basic principles of rational use of medicines.
§ Pharmacists and Prescribers play important roles in reporting of ADRs.
