Definitions

Clinical description

Adverse Event (AE)

• Any untoward medical occurrence in a patient. It does not necessarily have a causal relationship

with any medicine administered.

Adverse drug reaction (ADR)

• An unintended noxious response to a medicinal product

Suspected adverse drug reaction

• May present as a new sign, symptom, abnormal laboratory finding or specific disease
• Suspected, but not confirmed to be caused by any medicine administered. Common causes of AEs

include advancement/complication of the underlying disease, manifestation of a new disease, or indeed the medicine administered.

• Healthcare workers must report all suspected ADRs to the National Pharmacovigilance Centre at

Pharmacy and Medicines Regulatory Authority (PMRA)

Side effect (SE)

• An unintended effect of a medicinal product occurring at doses normally used in humans, which is

related to its pharmacological properties.

• All ADRs are AEs, but not all AEs are ADRs. All AEs and ADRs are harmful, but SEs can be either

harmful or beneficial.

Pharmacovigilance 117 Safety signal

• An ADR which was previously either unknown or poorly documented in terms of its distribution,

severity, incidence or clinical presentation.

• It is not possible, especially at bed side, to determine whether an individual case constitutes a

safety signal.

• Pharmacovigilance aims to detect safety signals for period evaluation of the benefit-risk balance

of the medicine.