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.

 

Schedule Y

The legislative requirements of pharmacovigilance in India are guided by specifications of  Schedule Y7 of the DC Act and the DC Rules thereto. It sets forth, for example, regulations pertaining to preclinical and clinical studies for the development of a new drug, as well as clinical trial requirements for the import,manufacture and receipt of marketing approval for a new drug in India. It also includes the approval procedures for clinical trial and other documentation to be submitted with the sponsor’s application, with attention to the responsibilities of the sponsor, requirements of informed consent, responsibilities of Ethics Committees and details of the four phases of trials. Schedule Y also requires compliance with Good Clinical Practice Guidelines issued by CDSCO, the Directorate General of Health Services and the government of India.


Global Pharmacovigilance Laws & Regulations: The Essential Reference 156 Schedule Y underwent thorough review several years ago. Its latest amendment, dated January 20, 2005, aimed to underscore the continued commitment of DCGI to ensure pharmaceutical companies’ adequate compliance with pharmacovigilance obligations. The amended Schedule Y also attempts to better define the responsibilities of pharmaceutical companies for their marketed products, as well as responsibilities for reporting adverse events from clinical trials. For a complete understanding of reporting responsibilities specific to clinical trials conducted in India, Schedule Y should be read along with Rules 122A,122B, 122D, 122DA, 122DA and 122E of the DC Rules.


As specified in Schedule Y, a pharmaceutical company holding one or more marketing  licenses in India should ensure that it has in place an adequate pharmacovigilance system for its product(s). When two or more marketed products are identical in all aspects except  their trade names, each pharmaceutical company holding a marketing license is obliged to independently meet their own pharmacovigilance obligations. This includes the establishment and maintenance of appropriate systems to collect, collate and evaluate information
about suspected adverse reactions. A pharmaceutical company can achieve this either by setting up in-house systems for pharmacovigilance or by entering into contractual agreements  with Contract Research Organizations (CROs) specializing in pharmacovigilance  functions.