An Article on Pharmacovigilance in Vaccines

Here you go with the link on Pharmacovigilance in Vaccines -

http://www.ijp-online.com/article.asp?issn=0253-7613;year=2010;volume=42;issue=2;spage=117;epage=117;aulast=Budhiraja

Signal in Pharmacovigilance

A signal is a set of data constituting a hypothesis that is relevant to the rational and safe use of a drug in humans-  R. Meyboom et al. 1997

A signal is reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously- Edwards et al. 2000

Signal Generation:
i) three convincing ADR-reports
ii) # specified ADR-Reports/ # Prescriptions
iii)# specified ADR-Reports (PRRs)/ all Reports
iv) # specified Reports / Exposed Persons //Background Incidence

Purple Guide in Pharmacovigilance

In November 2008, the MHRA issued the 'Good Pharmacovigilance Practice Guide'. Also known as 'The Purple Guide  

Commercial pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions. This text complements current legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance.

This guide was primarily developed for UK Marketing Authorisation Holders (MAHs). It will also be of great interest to pharmacovigilance consultants. The use of third-party service providers for pharmacovigilance activities is quite common, particularly for smaller organisations which do not have in-house pharmacovigilance expertise. The guide references European legislation and guidance and so should be applicable across Europe.