Many times, we come across Pharma companies that want to set up a Pharmacovigilance system but are clueless about how they should start. A similar situation may even be faced by some countries, which are not yet a part of the WHO Programme for International Drug Monitoring. The WHO PV Resources is a collection of resources and information needed for the practice of Pharmacovigilance. WHO has developed an interactive website and the same can be accessed from: https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/resources-and-support/

The primary objective for developing this ToolKit is to ensure that Pharmacovigilance practitioners in low- and middle-income countries get access to information on the processes and activities involved in Pharmacovigilance, and that too from a trusted source.

Which are the Sections?

1. Introduction – This section includes Pharmacovigilance basics and guidance regarding various Pharmacovigilance methods

2. Pharmacovigilance Systems – This section provides guidance on setting up a functional national Pharmacovigilance Centre.

3. Setting up a Pharmacovigilance Centre – As the name explains, this section guides steps, logistics as well as potential issues.

4. WHO PIDM – This section provides guidance on the WHO Programme for International Drug Monitoring (PIDM) and how to join the same.

5. Pharmacovigilance Data – This section provides information on how the collected data can be used or utilized.

6. Signal Detection – This section provides information on identification methods and data mining.

7. Benefit-Risk Assessment – This section provides information on the various benefit-risk assessment models and methods.

8. Communication in Pharmacovigilance – This section provides guidance on the importance of communication in Pharmacovigilance, the methods to be used, and how to communicate during a crisis.

9. Crisis Management – This section provides guidance on what is a crisis and how this can be managed.

There is also an exciting Quiz for those who know how to set up a Pharmacovigilance Centre. Further icing on the cake; there are lots of free and useful downloads too. There is also a video on benefit-risk assessment. The PV Toolkit is a fantastic initiative from WHO, which can benefit even the Pharma companies that want to set up a Pharmacovigilance System or redefine their existing systems.