• Appendix


It is possible to receive millions of adverse drug reaction reports. This represents a huge chunk of data, which can be analyzed to find both new and already existing relationships. It is also important, as a pharmacovigilance centre to constantly do research.

Pharmacovigilance is an interesting and ever changing field; new topics are being discussed and innovative methods are frequently introduced into the field. This is why constantly updated data should be an essential part of any pharmacovigilance centre’s activities.

Data sources

Data Analyses

Individual case assessment


The establishment of relationship between medicine intake and occurrence of adverse events is an important activity in pharmacovigilance. Different national pharmacovigilance centres have different procedures for carrying out case causality assessment, driven sometimes by differing philosophies on the need for and importance of case causality assessment. The material below is reproduced from the WHO Manual “A practical handbook on the pharmacovigilance of antiretroviral medicines” authored by Dr. David Coulter, formerly Director of the Intensive Medicines Monitoring Programme in New Zealand (WHO, 2009).


Establishing causality or a relationship between a drug and an adverse event involves two basic questions. These questions need to be addressed separately:

  • Is there a convincing relationship between the drug and the event?
  • Did the drug actually cause the event?

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