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Glossary of Terms
 

Adverse Event: An adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.  

Adverse Drug Reaction: as established by regional regulations, guidance, and practices, concern noxious and unintended responses to a medicinal product.  The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.

A reaction, in contrast to an event, is characterized by the fact that a causal relationship between the drug and the occurrence is suspected. For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction.  

Health Care Professional includes but not limited to medical doctors, pharmacists, nurses, dentists, allied health professionals, midwives, caregivers etc. 

Medical Products: include Pharmaceutical products (prescription and non prescription drugs), vitamins and minerals, herbal medicines, traditional medicines, biotechnology products and biologically-derived products such as vaccines, serums, and blood derived products; cells, tissues and organs; disinfectants and radiopharmaceuticals. 

Serious AE and/or Serious ADR: any untoward medical occurrence that at any dose:

• results in death,
• is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe),
• requires inpatient hospitalization or results in prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity,
• is a congenital anomaly/birth defect,
• is a medically important event or reaction.

Medical and scientific judgment should be exercised in deciding whether other situations should be considered serious such as important medical events that might not be immediately life-threatening or result in death or hospitalization but might jeopardize the patient or might require intervention to prevent one of the other outcomes listed in the definition above. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, or development of drug dependency or drug abuse. 

Spontaneous Report or Spontaneous Notification

An unsolicited communication to a company, Competent Authority or other organization that describes an adverse drug reaction in a patient given one or more medicinal products and which does not derive from a study or any organized data collection scheme.