Table of Contents  
Year : 2013  |  Volume : 4  |  Issue : 4  |  Page : 307-308  

The pharmacovigilance toolkit

Department of Pharmacology, Xavier University School of Medicine, Aruba, Dutch Caribbean

Date of Web Publication10-Oct-2013

Correspondence Address:
P Ravi Shankar
Xavier University School of Medicine, #23, Santa Helenastraat, Oranjestad Aruba, Dutch Caribbean

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Source of Support: None, Conflict of Interest: None

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How to cite this article:
Shankar P R. The pharmacovigilance toolkit. J Pharmacol Pharmacother 2013;4:307-8

How to cite this URL:
Shankar P R. The pharmacovigilance toolkit. J Pharmacol Pharmacother [serial online] 2013 [cited 2020 Nov 26];4:307-8. Available from:

Pharmacovigilance (PV), a key intervention for promoting the safe and rational use of medicines is especially important in developing countries where there is often no legal requirement for medicines to be tested in indigenous populations before marketing approval, medicines quality is not always assured and allopathic medicines are often used along with complementary and alternative remedies increasing the risk of drug interactions. Information about PV and setting up and running a reporting system are often lacking in developing countries. Considering the information needs of practitioners the World Health Organization (WHO) recently created an online collection of resources on PV titled "The PV toolkit." The toolkit brings together in easily accessible manner information and resources on PV. Disease specific PV tools are available for tuberculosis, human immunodeficiency virus and malaria.

The "quick tour" section on the home page has subsections titled "What is the PV toolkit?," "what is PV?," "setting up a PV center," "PV methods," "communication and crisis management in PV," "resources," "PV funding and support," "monitoring and evaluation," and "PV of special cases." The "what's new?" section contains hyperlinks to WHO publications dealing with medicine safety and a link to the e-learning course on vaccine safety. A hyperlink to the World Medicines situation 2011 dealing with PV and safety of medicines is also available. The home page of the toolkit demonstrates its focus on Africa as all photographs are from the continent.

The "regulatory authorities" section contains a link to the Uppsala Monitoring Center (UMC), the global center for PV and its different services. I especially liked the links provided to drug regulatory authority websites of different countries. The links have been arranged in the alphabetical order of country names. The "Forum" section takes you to the website of UMC Africa with the discussion forum presented below it. The reader has access to different sections of the UMC Africa website and at the same time can participate in the forum discussions from the same webpage.

The toolkit section contains different sub-sections like setting up a PV center, joining the international PV program, definition and terminologies, signal identification, resources, links to organization websites, which provide information on this subject and universities and the organization offering courses in PV. The chapters dealing with different areas have been linked with the quick tour section on the home page using hyperlinks to different chapters. Once the reader navigates to a particular chapter, hyperlinks to different chapters in ascending order are displayed on the left.

Chapter 1 provides a basic introduction to PV and a link to a WHO booklet dealing with safety monitoring of medical products. Chapter 3 deals with the practical issue of setting up a PV center with a link to a WHO manual on the subject and organizations which could assist in the process. The fourth chapter describes how to join the WHO international program for drug monitoring. Methods of PV and terminologies are covered in Chapters 5 and 6. Chapter 11 deals with resources for PV. The literature resources section provides a comprehensive list of books, journals, WHO-UMC publications, data sources, scientific article providers dealing with patient safety. Chapter 12 provides links to various organizations involved in PV. The PV assessment tool will be of interest to organizations involved in setting up and developing a PV program. The appendix contains standard operating procedure for both spontaneous reporting and cohort event monitoring and a glossary of terms. The procedure for spontaneous reporting will be of special interest as it is the major form of reporting in most regions. The buttons enabling you to download a PDF version of the information on the webpage, to print the webpage and to e-mail the page to a friend are useful.

The search function on the website works well and the contact section enables the reader to contact the WHO Collaborating Centre for advocacy and training in PV, Accra, Ghana who maintain the website. The site brings together resources from a number of sources and can serve as a one-stop shop for PV requirements. Certain sections of the website are however password protected while others are under construction. The website is well-designed and easy to use. It is very effective as a portal leading to a wealth of information resources about PV. The toolkit is also available on a USB drive for use in areas with poor internet connectivity. However, I would like certain sections of the website to also focus on PV issues in other regions of the globe though I am aware of and appreciate the pressing need for PV in Africa.

About the toolkit: WHO Collaborating Center for Advocacy and Training in Pharmacovigilance, Accra, Ghana. Pharmacovigilance Toolkit. version 2.4. Version date March 2013. Available from:


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