What is a Serious Adverse Event (SAE)?

June 17, 2011 - PRLog -- Introduction
Drugs and medicines are released to the public after passing through several testing phases hich 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.

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. Attribution: The health professional further attributes the cause of the reaction by grading its cause to the concerned medicine. By a process of elimination, the process narrows down causes from `not related’ to `definite’. Collateral verification: All medicines available in the marketplace are mandatorily expected to outline side effects in their packaging material. In cases of therapy where more serious medication is necessary, i.e. anesthesia, it is a common practice to get the patients to sign a consent form. The consent form should necessarily detail the expected side effects of the medicine. Thus, using either or both of the above, the healthcare professional can determine the reaction as an unexpected adverse event or as an expected side effect. When the healthcare professional is convinced that the patient is undergoing a serious adverse reaction to a drug or medicine, he or she is duty bound to report this immediately to the FDA.

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