Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.
Adverse Drug Reaction:
The detection, assessment, understanding and prevention of ADR are the objectives of the Pharmacovigilance.
ADR in the European Union:
- An ADR is characterized as unintended and noxious responses to a drug and implies a possible causal relationship between the drug and the adverse event. ADR can happen during clinical trials or once the product is on the market.
- ADR should be distinguished from untoward medical occurrence occurring after drug administration and where a causal relationship between the drug and the medical occurrence is excluded (called. Adverse Event).
- Non-serious ADRs should be distinguished from the serious ones which can result in death, life-threatening, hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or congenial anomaly / birth defect.