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TN PWT trains selected Pharm D graduates for pharmacovigilance, to be outsourced by companies
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Peethaambaran Kunnathtoor, Chennai
August 08 , 2017
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With a view to help the pharmaceutical companies’ efforts in
pharmacovigilance activities by enabling them outsource trained people
for assessing the risks and benefits of medicines, the Tamil Nadu
Pharmaceutical Sciences Welfare Trust (TNPWT) has decided to hold
training programmes for Pharm D graduates in pharmacovigilance.
With
this, the industry as well as clinical research organisations (CROs),
can utilize the potential of the trained Pharm D graduates in collecting
new information about benefits and risks associated with drugs, newly
developed and already in the market. The manufacturers can, either
recruit them for setting up their own pharmacovigilance programmes (PvP)
or they can outsource them on contract basis.
The Trust
office-bearers, who belong to various segments in the pharmacy
profession, industry and regulatory agencies, find that graduates with
Pharm D qualification are appropriate candidates to identify, assess,
monitor, report and document the adverse reactions of a drug (ADR). So,
they have selected 50 Pharm D graduates passed out from ten pharmacy
colleges in the state to be trained for pharmacovigilance activities.
The
first batch of the training programme was started at the Trust office
on August 3 and culminated on August 5. The chairman of the Trust, SV
Veeramani inaugurated the first training programme.
“Since the
Pharm D graduates have expert knowledge on patients’ health conditions,
disease state, therapeutic knowledge and evidence based practice
compared to graduates of B Pharm or any others, they can take active
roles in pharmacovigilance. The trained personnel can be hired by each
manufacturing company for their PvP activities or appoint them in their
independent pharmacovigilance centre,” said SV Veeramani, chairman of
TNPWT.
He said a pharmaceutical company can meet its
pharmacovigilance obligations either by setting up in-house systems for
pharmacovigilance or can enter into contractual arrangements with
contract research organizations specializing in pharmacovigilance
function.
According to sources from the Pharmaceutical Welfare
Trust, the selected Pharm D graduates will be given hands-on training in
‘Terminology & involving pharmacovigilance and methods of adverse
event reports, role of healthcare professionals including pharmacists in
PvP, effective communication setting up of pharmacovigilance system,
transcription of data case study to reporting form, ADR/AE and its
clinical relevance, logistic methodology of causality of assessment,
pharmacovigilance programme in India & its regulatory implication,
regulatory aspect of pharmacovigilance, role of CDSCO in PvP and
integration of national health programmes in PvP.
While speaking
to Pharmabiz, Veeramani, who is the immediate past president of the
Indian Drugs Manufacturers Association (IDMA), said, in compliance with
the recent amendment to Schedule Y of the Drugs & Cosmetics Rules,
1945, vide Gazette notification No.GSR 287 (E) dated March 8, 2016,
pharmacovigilance has become mandatory for marketing authorization
holders (MAHs) in India. To ensure the effective implementation, there
is an urgent need for the MAHs (manufacturers & importers) to set up
a pharmacovigilance system in their sites.
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