Serious Event or Serious Suspected Adverse Reaction-Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes

• Death
• A life-threatening adverse event
• Inpatient hospitalization, or prolonged of existing hospitalization
• A persistent disability to conduct normal functions
• A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

A Life Threatening Adverse Drug Experience
Any event that occurred due to the use of drug, if it places the patient or the subject at immediate risk of death or if the product or drug is continued it may result in death is described as a life threatening adverse event.
Some of the examples are:

• Hemorrhaging and internal bleeding with rapid drop in blood pressure,
• Loss of consciousness from increase in pressure on the brain etc.

Hospitalization
Any event that occurred due to which the patient/subject is admitted to the hospital for longer than 24 hours or if the stay in the hospital is prolonged due to the adverse event.
Disability
Any event that occurred due to which the patient/subject is unable to conduct normal life functions
Examples are

• Loss of speech,
• Fatigue( if the subject cannot get out of bed at all),
• Loss of memory,
• Paralysis etc

Congenital Anomaly
Exposure to a medical product before conception or during pregnancy results in an adverse outcome in the child is described as congenital anomaly. Thalidomide is the best example of a drug causing congenital anomalies with babies born with deformed arms and legs.

Author- Sirisha Boidapu, Pharmacist, PV Professional