Defining 'surveillance' in drug safety

Area of Science:

• Pharmacovigilance and Pharmacoepidemiology
• Public Health Research
• Infectious Disease Epidemiology

Background:

• The concept of surveillance in pharmacovigilance evolved from infectious disease epidemiology.
• Previous definitions of surveillance and its modifiers (e.g., active, passive) were surveyed.

Purpose of the Study:

• To survey the etymology, usages, and definitions of surveillance in health-care product contexts.
• To propose a refined, comprehensive definition of surveillance for health-care products.

Main Methods:

• Surveyed etymology, usages, and definitions of surveillance.
• Identified essential definitional features of surveillance.
• Proposed a new definition based on surveyed ideas and real-world pharmacovigilance.

Main Results:

• Surveillance involves populations, is distinct from monitoring, and can be performed repeatedly.
• Surveillance is non-interventional but can use diverse evidence types.
• Key features include data collection, management, analysis, interpretation, and post-signal actions for benefit/harm assessment.

Conclusions:

• Qualifiers like 'active' or 'passive' add ambiguity to surveillance.
• A proposed definition integrates systematic data collection, analysis, and interpretation of benefits and harms.
• The purpose of surveillance is to identify, evaluate, understand, and communicate product effects for harnessing benefits or mitigating harms.