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Mind Maps of Pharmacovigilance Basics Mind Maps of Pharmacovigilance Basics

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Methodology of Pharmacovigilance
Passive Pharmacovigilance
Active measures are not
taken to look for adverse
effects/safety concerns
This is the most common
form of reporting (also
known as "spontaneous"
or "voluntary" reporting)
This method totally
depends on the initiative
and motivation of the
potential reporters
Case processing is a processing of ADR reports that the company receives from various
sources.
Active Pharmacovigilance
Active measures are taken to
look for adverse effects/safety
concerns
The events may be detected by
asking patients directly or
screening patient's records
Most comprehensive metl1od is
"Cohort Event Monitoring
(CE1r1)" Example: Intensive
Medicines Monitoring Program
(IMMP) in New Zealand and
Prescrip tion Event Monitoring
(PEM) in England
• Once the case of adverse event/reaction is received from any source (Telephone, fax, email,
licensing agreement, form, the regulators or other companies), the case is checked for 4
valid criteria i.e. minimum safety information.
If the case is valid, the adverse event/reaction coding is done using standardized
terminology from MedDRA and then the case is evaluated for its seriousness criteria by
triage team.
• A unique identity number is assigned to each individual case.
• Then the case is sent to the safety associate for data entry. The work of case processing
team starts now.
• The safety associate enters the case into safety database, performs coding (for disease and
medicines) and writing narratives of the case.
• In case of any query he/she seeks the follow up information from the reporter.
• After the data entry, the case is assigned to the QC (quality control) team, where the QC
person checks the work done by Safety associates.

• The case moves in the workflow to the Medical Reviewer who assesses the case for Medical
Fig: Pharmacovigilance Methodologies aspects, performs the causality assessment (relationship of given ADR and specific drug)
and gives a company comment on each case.

• Next step is Signal detection (identifying signals i.e. potential indicator of new ADR)
3.14 Pharmacovigilance Process Overview (Generalized) and risk management plan (risk assessment and risk minimization plan) post which the
analysis is completed through various methods like statistical methods (e.g. t-test for the
comparison of mean), data manipulation (e.g. tabular and graphics).

• Now the case is ready for submission to the regulatory authority and communication
to other partners. The submission team submits the Case to the regulatory authority
according to the local requirement.
The case processing steps are depicted in Fig - PV overview.
Fig: PV Process summarized