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More AMCs to be identified for access to WHO database through Vigiflow software as part of PvPI

Shardul Nautiyal, Mumbai
Tuesday, February 3, 2015, 08:00 Hrs  [IST]

Around 40 ADR Monitoring Centres (AMCs) out of the 150 are in the process of getting identified for registration with the Vigiflow software which is meant to report adverse drug reaction (ADR) data to World Health Organization (WHO) database on a consistent basis, as a part of the Pharmacovigilance Programme of India (PvPI), informed an official associated with the development.

Of the 150 AMCs set up under the PvPI, 110 centres have the Swedish software Vigiflow which helps in accurate reporting of ADRs with the help of Technical Data Associates (TDAs) working in 82 centres as of today. They are working in coordination with Indian Pharmacopoeia Commission (IPC) Ghaziabad for final analysis and reports.

TDAs are accountable to collect information from the patients, perform follow up with them, enter information in the prescribed software (Vigiflow) and sending them to IPC for further analysis and documentation. IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through VigiFlow to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.

Vigiflow is a software given to the PvPI free of cost and prescribed to AMCs based on their efficiency to deliver in terms of frequency and quality of reports. Drug Controller General of India (DCGI) is the authority to identify the AMCs to further train them on using Vigiflow software and thereafter authorise password to them for linking with the data base of WHO called as Vigibase.

Pharmacovigilance as a science and specialty is slowly picking up in the country but research and reporting outcomes are limited. Experts inform, "Effective communication of the safety data to the general public is a key challenge which need to be addressed on a war footing. Letter writing, package insert warnings are some of the conventional methods used for communication of pharmacovigilance knowledge."

It has also been given to understand that there has also been lack of methodological approach and the specialty of pharmacovigilance has been more hospital focussed than community focussed. Single-centered studies has been done versus multiple centres and a lot of research on the subject remains unpublished are some of the key drivers fueling the demand for an effective pharmacovigilance programme in India.

 

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