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IPC Ghaziabad becomes WHO collaborative centre for PV in public health programmes
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Shardul Nautiyal, Mumbai
July 27 , 2017
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In order to support Word Health Organisation (WHO) in areas of
pharmacovigilance(PV) in public health programmes and regulatory
services, Indian Pharmacopoeia Commission (IPC) PV division has been
assigned the status of WHO collaborating centre which will help promote
medicine safety not only in India and globally but will also provide
guidelines and support in policy decision making process of WHO.
There
are 7 WHO collaborative centre globally in pharmacovigilance and WHO
collaborative centre for PV in public health and regulatory services
from India will serve as the 8th centre.
Uppsala Monitoring
Centre (UMC) was the first WHO Collaborating Centre to be established
for pharmacovigilance when, in 1978, the scientific and technical
responsibility of the WHO programme for international drug monitoring
was transferred to Sweden.
The WHO programme for international
drug monitoring is a group of more than 150 countries that share the
vision of safer and more effective use of medicines. UMC has been
responsible for the technical and operational aspects of the programme
since 1978.
The UMC is involved closely with WHO HQ in
initiatives in promoting pharmacovigilance in HIV/AIDS, malaria and
tuberculosis treatment programmes that major donors (Global Fund, Gates
Foundation etc) are supporting in countries where only rudimentary
systems for pharmacovigilance exist.
Many of the medicines
employed by these public health programmes are new and/or have safety
concerns associated with them. This includes collaboration with WHO and
others on the establishment and training of a pharmacovigilance field
force to actively assemble case information from the programme treatment
centres.
Other organisations provide staff to enter this data
into country-specific databases, using the UMC's VigiFlow software. A
team of signal reviewers will be trained to analyse the collected case
information and to highlight any indication of new patient safety
concerns. Such information will be provided to programme managers and
regulatory authorities in each country in which the system is operating
as well as to the international community where relevant.
UMC has
a key role by providing a number of services like training of the field
force in the collection of relevant patient and case details, access to
the VigiFlow software for management of individual case safety reports,
providing tools for data analysis, training of staff in case
assessment, signal analysis and benefit/harm evaluation and
communicating results to relevant national authorities and international
partners.
Vigiflow is a software given to the Pharmacovigilance
Programme of India (PvPI) free of cost and prescribed to Adverse Drug
Monitoring Centres (AMCs) based on their efficiency to deliver in terms
of frequency and quality of reports.
IPC has been assigned to
update information on ADRs that is being reported in India from across
all its centres through Vigiflow software to the Uppsala Monitoring
Centre (UMC) in Sweden, which is WHO's collaborating centre for
international drug monitoring.
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