What Is a Serious Adverse Event (SAE)?
Introduction Drugs and medicines are released to the public after passing through several testing phases which are closely monitored by regulatory and governmental authorities.
Over and above this, all expected and noted side effects are examined and highlighted in the medicine's packaging or brochure material.
However, if a new reaction to a medicine occurs, which is not mentioned in the packaging material, this reaction is defined as a `side effect'.
A side effect can be symptomatic, like a headache or nausea or it can be severe and result in death or require hospitalization.
Such reactions to medicines are called 'Serious Adverse Reactions' or SAE's.
Serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others.
Understanding SAE's: The FDA describes serious adverse reactions as, 'any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others.
' The keyword in the above description to be noted is `untoward'.
This essentially means that the reaction is totally unexpected involving unmitigated risk.
Such reactions should be immediately reported to the FDA.
Serious adverse effects can be classified by their end results, which are: Death: If a person's death is the outcome of an adverse reaction to a medicine.
Life threatening: If the patient develops serious symptoms which may result in death, and the cause of this illness can only be attributed to a medicine and not to any existing ailments.
Hospitalization: If a patient requires immediate hospitalization or a prolonged stay to cure the ailment which is a result of a serious adverse reaction to a medicine.
Permanent Damage: If the person's normal ability to control and conduct life functions is hampered or disrupted and the end result is a permanent, incurable damage to the person's physical function or structure.
Congenital: A medical product consumed during pregnancy results in a serious ailment or affliction in the child.
Steps involved in reporting an SAE Protocol requires that all serious adverse reactions are reported within 48 hours of their occurrence to the FDA.
Grading the reaction: This is the first step in evaluating and reporting a serious adverse reaction, where the concerned healthcare professional grades or categorizes the reaction as serious or not serious.
Over and above this, all expected and noted side effects are examined and highlighted in the medicine's packaging or brochure material.
However, if a new reaction to a medicine occurs, which is not mentioned in the packaging material, this reaction is defined as a `side effect'.
A side effect can be symptomatic, like a headache or nausea or it can be severe and result in death or require hospitalization.
Such reactions to medicines are called 'Serious Adverse Reactions' or SAE's.
Serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others.
Understanding SAE's: The FDA describes serious adverse reactions as, 'any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others.
' The keyword in the above description to be noted is `untoward'.
This essentially means that the reaction is totally unexpected involving unmitigated risk.
Such reactions should be immediately reported to the FDA.
Serious adverse effects can be classified by their end results, which are: Death: If a person's death is the outcome of an adverse reaction to a medicine.
Life threatening: If the patient develops serious symptoms which may result in death, and the cause of this illness can only be attributed to a medicine and not to any existing ailments.
Hospitalization: If a patient requires immediate hospitalization or a prolonged stay to cure the ailment which is a result of a serious adverse reaction to a medicine.
Permanent Damage: If the person's normal ability to control and conduct life functions is hampered or disrupted and the end result is a permanent, incurable damage to the person's physical function or structure.
Congenital: A medical product consumed during pregnancy results in a serious ailment or affliction in the child.
Steps involved in reporting an SAE Protocol requires that all serious adverse reactions are reported within 48 hours of their occurrence to the FDA.
Grading the reaction: This is the first step in evaluating and reporting a serious adverse reaction, where the concerned healthcare professional grades or categorizes the reaction as serious or not serious.
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