PHARMACOVIGILANCE

Pharmacovigilance
The science and activities relating to the
detection, assessment, understanding, and
prevention of adverse effects or any other drug-
related problem.
Aim:
• To improve patient care and safety in relation to the use of medicines
• To contribute to the assessment of benefit, harm, effectiveness 
• Track serious adverse events
• Educate on drug safety
Difference between ADR and AE

• ADR is associated with a causational relationship between the

medication and the injury.

• Within AEs, such events are viewed as side effects and causative
relationships between a drug and the event cannot be established.
AEs can also be related to medical procedures.
several facets of AE reporting:

• Individual Case Safety Report.

• Expedited reporting.
• Clinical trial reporting.
• Spontaneous reporting.
• Aggregate reporting.
Regulatory authorities

• United States – FDA : Food and Drug Administration

• European Union - European Medicines Agency
• Canada -Health Canada
•  India- CDSCO : Central Drugs Standard Control Organization 
• UK- MHRA: Medicines and Healthcare products Regulatory Agency 
softwares used in pharmacovigilance are:

• Oracle Argus Safety.

• ArisG.
• Oracle Adverse Event Reporting System (AERS)
• ClinTrace.
• PvNET.
• repClinical.
• Vigilanz Dynamic Monitoring System.
• WebVDME Pharmacovigilance Signal detection and Signal management
software.
Yellow Card scheme

• UK system for collecting information on suspected adverse drug

interactions to medicines and vaccines.
• Created in 1964, after the Thalidomide tragedy.
• It is run by the Medicines Control Agency on behalf of the Committee
on Safety of Medicines.
• Anyone can report a Yellow Card, from healthcare professionals to
members of the public. 
VigiBase
• WHO's global database of reported potential side effects of medicinal
products, is regularly screened for possible safety signals requiring
further investigation and action to prevent harm to patients.
• According to the WHO-UMC definition, a safety signal refers
to information on a new or known side effect that may be caused by a
medicine and is typically generated from more than a single report of
a suspected side effect.
3 types of signals
• 1.confirmed signals-causal relationship between the drug and adverse
event
• 2.refuted(false) signals-no causal relationship
• 3.unconfirmed signals-require further investigation