Case assessments in Drug Safety and Pharmacovigilance
How does the information from a consumer having an adverse drug reaction reach a Drug Safety Associate or a Pharmacovigilance scientist in the Drug Safety Department? How is a case prioritized and classified as serious or non serious? How important is case assessment?
If one understands the importance of time and timeline in Pharmacovigilance – one would understand the necessity for case assessment. The immediate steps after triage is to assess if the reported Adverse Drug Reaction is “Serious or Non serious”, “Expected or Unexpected”. The Casualty assessment is also done wherein it’s established if the incident was related or unrelated. These above, are the three elements when assessing a case.
A case can be described as Serious : Fatal or Serious : Non-Fatal. Depending on the prerequisites given by the drug safety department and gauging the history of illness/comorbid conditions of a consumer – one assesses the serious case as Fatal or Non Fatal. The timelines for both are different and sincerely followed.
- Serious: Fatal/Life-threatening – 7 calendar days
- Serious: Non-fatal/Non-life-threatening -15 calendar days
A case assessed as non serious has a timeline of 90 days.
To understand the ‘Expected or Unexpected’ element of Case assessment, one can look at its definition – “One for which its nature or severity is consistent with that included in the appropriate reference safety information (e.g. Investigator’s brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product).”
The third element – “Causality” helps in establishing a direct relationship between the adverse drug reaction and the drug. As per the definition, it is a- “Method for assigning probability of causation to a suspected adverse drug reaction”.
After it’s assessment the case moves forward in the work flow in the Drug safety department as per the essential guidelines.
