What is Pharmacovigilance?

„To know of something that is harmful to another person, who does not know, and not telling, is unethical.” Ethics in Pharmacovigilance - WHO

Pharmacovigilance:          pharmakon (Greek)—medicinal substance
                                    vigilare (Latin)—to keep watch, to keep awake

Meaning: to keep watch over the safe use, effectiveness, new or known adverse reactions of a medicinal product. 
 
Used to cover all clinical aspects of drug safety:

- pre-marketing
- healthy and patient subjects 
- post-marketing

What is Pharmacovigilance?

WHO 2002: „The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

Objectives of PV:

  §         Identify previously unknown hazards
§         Evaluate changes in benefits and risks
§         Provide optimal information for users
§         Take action to promote safer use
§         Monitor impact of action taken

Why is PV so important?

for instance:

-  ADRs are one of the most common disease
- among the first ten cause of death is adverse event of medicine
- many percent of hospitalization is ADR-related